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1.  A systematic mapping review of effective interventions for communicating with, supporting and providing information to parents of preterm infants 
BMJ Open  2011;1(1):e000023.
Background and objective
The birth of a preterm infant can be an overwhelming experience of guilt, fear and helplessness for parents. Provision of interventions to support and engage parents in the care of their infant may improve outcomes for both the parents and the infant. The objective of this systematic review is to identify and map out effective interventions for communication with, supporting and providing information for parents of preterm infants.
Design
Systematic searches were conducted in the electronic databases Medline, Embase, PsychINFO, the Cochrane library, the Cumulative Index to Nursing and Allied Health Literature, Midwives Information and Resource Service, Health Management Information Consortium, and Health Management and Information Service. Hand-searching of reference lists and journals was conducted. Studies were included if they provided parent-reported outcomes of interventions relating to information, communication and/or support for parents of preterm infants prior to the birth, during care at the neonatal intensive care unit and after going home with their preterm infant. Titles and abstracts were read for relevance, and papers judged to meet inclusion criteria were included. Papers were data-extracted, their quality was assessed, and a narrative summary was conducted in line with the York Centre for Reviews and Dissemination guidelines.
Studies reviewed
Of the 72 papers identified, 19 papers were randomised controlled trials, 16 were cohort or quasi-experimental studies, and 37 were non-intervention studies.
Results
Interventions for supporting, communicating with, and providing information to parents that have had a premature infant are reported. Parents report feeling supported through individualised developmental and behavioural care programmes, through being taught behavioural assessment scales, and through breastfeeding, kangaroo-care and baby-massage programmes. Parents also felt supported through organised support groups and through provision of an environment where parents can meet and support each other. Parental stress may be reduced through individual developmental care programmes, psychotherapy, interventions that teach emotional coping skills and active problem-solving, and journal writing. Evidence reports the importance of preparing parents for the neonatal unit through the neonatal tour, and the importance of good communication throughout the infant admission phase and after discharge home. Providing individual web-based information about the infant, recording doctor–patient consultations and provision of an information binder may also improve communication with parents. The importance of thorough discharge planning throughout the infant's admission phase and the importance of home-support programmes are also reported.
Conclusion
The paper reports evidence of interventions that help support, communicate with and inform parents who have had a premature infant throughout the admission phase of the infant, discharge and return home. The level of evidence reported is mixed, and this should be taken into account when developing policy. A summary of interventions from the available evidence is reported.
Article summary
Article focus
A systematic mapping review to identify and synthesise evidence of effective interventions for communicating with, supporting and providing information for parents of preterm infants.
Key messages
The review highlights the importance of encouraging and involving parents in the care of their preterm infant at the neonatal unit to enhance their ability to cope with and improve their confidence in caring for the infant, which may also lead to improved infant outcomes and reduced length of stay at the neonatal unit.
Interventions for supporting parents included: (1) involving parents in individualised developmental and behavioural care programmes (eg, Creating Opportunities for Parent Empowerment (COPE), Neonatal Individualised Developmental Care and Assessment Programme, Mother–Infant Transaction Programme (MITP)) and behavioural assessment programmes; (2) breastfeeding, kangaroo-care and infant-massage programmes; (3) support forums for parents; (4) interventions to alleviate parental stress; (5) preparation of parents for various stages—for example, seeing their infant for the first time, preparing to go home; (6) home-support programmes.
Involving parents in the exchange of information with and between health professionals is important, with various modes of providing this information reported—for example, ward rounds with doctors, discussion around infant notes, websites and hard-copy information.
Strengths and limitations of this study
Strengths
This is the first review to synthesise the evidence of interventions to support parents of preterm infants through improved provision of information, improved communications between parents and health professionals, and alleviation of stress at all stages of a parent's journey through the neonatal unit. It highlights relatively inexpensive interventions that can be integrated into their pathway through the neonatal unit and return home, enhancing parental coping and potentially improving infant outcomes and reducing the infants length of stay at the neonatal unit.
Limitations
The quality of the evidence that this review reports is variable, and includes all types of study designs. It has been difficult to evaluate one piece of evidence over another because of the nature of the evidence. For example, whether randomised controlled trials (RCTs) are an appropriate method of evaluating the parents' experiences of interventions over and above, say, a qualitative study is debatable. While the RCT studies are more objective, they often fail to provide a more in-depth empirical reality of parents' experiences of having a premature infant. A well-conducted RCT may not provide a true reflection of improved self-esteem or empowerment, for example, whereas a qualitative study provides an understanding of the experiences. Furthermore, evaluation of such complex interventions is challenging because of the various interconnecting parts of the pathway reported in figure 2.
It is therefore very difficult to evaluate the results to say that one study method is better than another. For this reason, we have been inclusive in our selection of studies, resulting in a large number of studies selected for the review. Being inclusive of studies benefits the evidence base by bringing together ‘experience’ studies in a systematic way gaining a greater breadth of perspectives and a deeper understanding of issues from the point of view of those targeted by the interventions. However, if studies were fatally flawed, they were excluded from the review.
doi:10.1136/bmjopen-2010-000023
PMCID: PMC3191395  PMID: 22021730
Social Health; community child health; paediatric intensive and critical care; education and training; quality in healthcare
2.  Post-neonatal Mortality, Morbidity, and Developmental Outcome after Ultrasound-Dated Preterm Birth in Rural Malawi: A Community-Based Cohort Study 
PLoS Medicine  2011;8(11):e1001121.
Using data collected as a follow-up to a randomized trial, Melissa Gladstone and colleagues show that during the first two years of life, infants born preterm in southern Malawi are disadvantaged in terms of mortality, growth, and development.
Background
Preterm birth is considered to be associated with an estimated 27% of neonatal deaths, the majority in resource-poor countries where rates of prematurity are high. There is no information on medium term outcomes after accurately determined preterm birth in such settings.
Methods and Findings
This community-based stratified cohort study conducted between May–December 2006 in Southern Malawi followed up 840 post-neonatal infants born to mothers who had received antenatal antibiotic prophylaxis/placebo in an attempt to reduce rates of preterm birth (APPLe trial ISRCTN84023116). Gestational age at delivery was based on ultrasound measurement of fetal bi-parietal diameter in early-mid pregnancy. 247 infants born before 37 wk gestation and 593 term infants were assessed at 12, 18, or 24 months. We assessed survival (death), morbidity (reported by carer, admissions, out-patient attendance), growth (weight and height), and development (Ten Question Questionnaire [TQQ] and Malawi Developmental Assessment Tool [MDAT]). Preterm infants were at significantly greater risk of death (hazard ratio 1.79, 95% CI 1.09–2.95). Surviving preterm infants were more likely to be underweight (weight-for-age z score; p<0.001) or wasted (weight-for-length z score; p<0.01) with no effect of gestational age at delivery. Preterm infants more often screened positively for disability on the Ten Question Questionnaire (p = 0.002). They also had higher rates of developmental delay on the MDAT at 18 months (p = 0.009), with gestational age at delivery (p = 0.01) increasing this likelihood. Morbidity—visits to a health centre (93%) and admissions to hospital (22%)—was similar for both groups.
Conclusions
During the first 2 years of life, infants who are born preterm in resource poor countries, continue to be at a disadvantage in terms of mortality, growth, and development. In addition to interventions in the immediate neonatal period, a refocus on early childhood is needed to improve outcomes for infants born preterm in low-income settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Being born at term in Africa is not necessarily straightforward. In Malawi, 33 of every 1,000 infants born die in the first 28 days after birth; the lifetime risk for a mother dying during or shortly after pregnancy is one in 36. The comparable figures for the United Kingdom are three infants dying per 1,000 births and a lifetime risk of maternal death of one in 4,700. But for a baby, being born preterm is even more risky and the gap between low- and high-income countries widens still further. According to a World Health Organization report in 2010, a baby born at 32 weeks of gestation (weighing around 2,000 g) in Africa has little chance of survival, while the chances of survival for a baby born at 32 weeks in North America or Europe are similar to one born at term. There are very few data on the longer term outcomes of babies born preterm in Africa and there are multiple challenges involved in gathering such information. As prenatal ultrasound is not routinely available, gestational age is often uncertain. There may be little routine follow-up of preterm babies as is commonplace in high-income countries. Data are needed from recent years that take into account both improvements in perinatal care and adverse factors such as a rising number of infants becoming HIV positive around the time of birth.
Why Was This Study Done?
We could improve outcomes for babies born preterm in sub-Saharan Africa if we understood more about what happens to them after birth. We cannot assume that the progress of these babies will be the same as those born preterm in a high-income country, as the latter group will have received different care, both before and after birth. If we can document the problems that these preterm babies face in a low-income setting, we can consider why they happen and what treatments can be realistically tested in this setting. It is also helpful to establish baseline data so that changes over time can be recorded.
The aim of this study was to document four specific outcomes up to the age of two years, on which there were few data previously from rural sub-Saharan Africa: how many babies survived, visits to a health center and admissions to the hospital, growth, and developmental delay.
What Did the Researchers Do and Find?
The researchers examined a group of babies that had been born to mothers who had taken part in a randomized controlled trial of an antibiotic to prevent preterm birth. The trial had previously shown that the antibiotic (azithromycin) had no effect on how many babies were born preterm or on other measures of the infants' wellbeing, and so the researchers followed up babies from both arms of the trial to look at longer term outcomes. From the original group of 2,297 women who took part in the trial, they compared 247 infants born preterm against 593 term infants randomly chosen as controls, assessed at 12, 18, or 24 months. The majority of the preterm babies who survived past a month of age (all but ten) were born after 32 weeks of gestation. Compared to the babies born at term, the infants born preterm were nearly twice as likely to die subsequently in the next two years, were more likely to be underweight (a third were moderately underweight), and to have higher rates of developmental delay. The commonest causes of death were gastroenteritis, respiratory problems, and malaria. Visits to a health center and admissions to hospital were similar in both groups.
What Do these Findings Mean?
This study documents longer term outcomes of babies born preterm in sub-Saharan Africa in detail for the first time. The strengths of the study include prenatal ultrasound dating and correct adjustment of follow-up age (which takes into account being born before term). Because the researchers defined morbidity using routine health center attendances and self-report of illnesses by parents, this outcome does not seem to have been as useful as the others in differentiating between the preterm and term babies. Better means of measuring morbidity are needed in this setting.
In the developed world, there is considerable investment being made to improve care during pregnancy and in the neonatal period. This investment in care may help by predicting which mothers are more likely to give birth early and preventing preterm birth through drug or other treatments. It is to be hoped that some of the benefit will be transferable to low-income countries. A baby born at 26 weeks' gestation and admitted to a neonatal unit in the United Kingdom has a 67% chance of survival; preterm babies born in sub-Saharan Africa face a starkly contrasting future.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001121.
UNICEF presents useful statistics on mother and child outcomes
The World Health Organization has attempted to analyse preterm birth rates worldwide, including mapping the regional distribution and has also produced practical guides on strategies such as Kangaroo Mother Care, which can be used for the care of preterm infants in low resource settings
Healthy Newborn Network has good information on initiatives taking place to improve neonatal outcomes in low income settings
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on research being conducted into preterm birth
Tommy's is a nonprofit organization that funds research and provides information on the risks and causes of premature birth
doi:10.1371/journal.pmed.1001121
PMCID: PMC3210771  PMID: 22087079
3.  Randomised trial of a parenting intervention during neonatal intensive care 
Objective
To evaluate the influence of parenting intervention on maternal responsiveness and infant neurobehavioural development following a very premature birth.
Design
Cluster‐randomised controlled trial, with a crossover design and three‐month washout period.
Setting
Six neonatal intensive care units.
Patients
Infants born <32 weeks' gestation.
Intervention
The Parent Baby Interaction Programme (PBIP) is a supportive, educational intervention delivered by research nurses in the neonatal intensive care unit, with optional home follow‐up for up to six weeks after discharge.
Main outcome measures
Parenting stress at 3 months adjusted age, as measured by the Parenting Stress Index (PSI). Other outcomes included the Neurobehavioural Assessment of the Preterm Infant (NAPI) and maternal interaction as assessed by the Nursing Child Assessment Teaching Scale (NCATS) and the responsivity subscale for Home Observation for Measurement of the Environment (HOME).
Results
112 infants were recruited in the intervention phases and 121 in the control phases. Mean standardised NAPI scores at 35 weeks did not differ between the PBIP and control groups. Both groups had low but similar NCATS caregiver scores before discharge (36.6 in the PBIP group and 37.4 in control, adjusted mean difference −0.7, 95% CI −2.7 to 1.4). At three months, adjusted age mean PSI scores for the PBIP group were 71.9 compared with 67.1 for controls (adjusted mean difference 3.8, 95% CI −4.7 to 12.4). NCATS scores and HOME responsivity scores were similarly distributed between the groups.
Conclusion
This early, nurse‐delivered, parent‐focused interaction programme intervention had no measurable effects on short‐term infant neurobehavioural function, mother–child interaction or parenting stresses.
doi:10.1136/adc.2006.103135
PMCID: PMC2675386  PMID: 17301114
cluster randomised trial; interaction; parental stress; preterm infant; very premature birth
4.  The effects of designation and volume of neonatal care on mortality and morbidity outcomes of very preterm infants in England: retrospective population-based cohort study 
BMJ Open  2014;4(7):e004856.
Objective
To examine the effects of designation and volume of neonatal care at the hospital of birth on mortality and morbidity outcomes in very preterm infants in a managed clinical network setting.
Design
A retrospective, population-based analysis of operational clinical data using adjusted logistic regression and instrumental variables (IV) analyses.
Setting
165 National Health Service neonatal units in England contributing data to the National Neonatal Research Database at the Neonatal Data Analysis Unit and participating in the Neonatal Economic, Staffing and Clinical Outcomes Project.
Participants
20 554 infants born at <33 weeks completed gestation (17 995 born at 27–32 weeks; 2559 born at <27 weeks), admitted to neonatal care and either discharged or died, over the period 1 January 2009–31 December 2011.
Intervention
Tertiary designation or high-volume neonatal care at the hospital of birth.
Outcomes
Neonatal mortality, any in-hospital mortality, surgery for necrotising enterocolitis, surgery for retinopathy of prematurity, bronchopulmonary dysplasia and postmenstrual age at discharge.
Results
Infants born at <33 weeks gestation and admitted to a high-volume neonatal unit at the hospital of birth were at reduced odds of neonatal mortality (IV regression odds ratio (OR) 0.70, 95% CI 0.53 to 0.92) and any in-hospital mortality (IV regression OR 0.68, 95% CI 0.54 to 0.85). The effect of volume on any in-hospital mortality was most acute among infants born at <27 weeks gestation (IV regression OR 0.51, 95% CI 0.33 to 0.79). A negative association between tertiary-level unit designation and mortality was also observed with adjusted logistic regression for infants born at <27 weeks gestation.
Conclusions
High-volume neonatal care provided at the hospital of birth may protect against in-hospital mortality in very preterm infants. Future developments of neonatal services should promote delivery of very preterm infants at hospitals with high-volume neonatal units.
doi:10.1136/bmjopen-2014-004856
PMCID: PMC4091399  PMID: 25001393
5.  The Effect of Changing Patterns of Obstetric Care in Scotland (1980–2004) on Rates of Preterm Birth and Its Neonatal Consequences: Perinatal Database Study 
PLoS Medicine  2009;6(9):e1000153.
Jane Norman and colleagues analyzed linked perinatal surveillance data in Scotland and find that between 1980 and 2004 increases in spontaneous and medically induced preterm births contributed equally to the rising rate of preterm births.
Background
Rates of preterm birth are rising worldwide. Studies from the United States and Latin America suggest that much of this rise relates to increased rates of medically indicated preterm birth. In contrast, European and Australian data suggest that increases in spontaneous preterm labour also play a role. We aimed, in a population-based database of 5 million people, to determine the temporal trends and obstetric antecedents of singleton preterm birth and its associated neonatal mortality and morbidity for the period 1980–2004.
Methods and Findings
There were 1.49 million births in Scotland over the study period, of which 5.8% were preterm. We found a percentage increase in crude rates of both spontaneous preterm birth per 1,000 singleton births (10.7%, p<0.01) and medically indicated preterm births (41.2%, p<0.01), which persisted when adjusted for maternal age at delivery. The greater proportion of spontaneous preterm births meant that the absolute increase in rates of preterm birth in each category were similar. Of specific maternal complications, essential and pregnancy-induced hypertension, pre-eclampsia, and placenta praevia played a decreasing role in preterm birth over the study period, with gestational and pre-existing diabetes playing an increasing role. There was a decline in stillbirth, neonatal, and extended perinatal mortality associated with preterm birth at all gestation over the study period but an increase in the rate of prolonged hospital stay for the neonate. Neonatal mortality improved in all subgroups, regardless of obstetric antecedent of preterm birth or gestational age. In the 28 wk and greater gestational groups we found a reduction in stillbirths and extended perinatal mortality for medically induced but not spontaneous preterm births (in the absence of maternal complications) although at the expense of a longer stay in neonatal intensive care. This improvement in stillbirth and neonatal mortality supports the decision making behind the 34% increase in elective/induced preterm birth in these women. Although improvements in neonatal outcomes overall are welcome, preterm birth still accounts for over 66% of singleton stillbirths, 65% of singleton neonatal deaths, and 67% of infants whose stay in the neonatal unit is “prolonged,” suggesting this condition remains a significant contributor to perinatal mortality and morbidity.
Conclusions
In our population, increases in spontaneous and medically induced preterm births have made equal contributions to the rising rate of preterm birth. Despite improvements in related perinatal mortality, preterm birth remains a major obstetric and neonatal problem, and its frequency is increasing.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Most pregnancies last about 40 weeks but increasing numbers of babies are being born preterm, before they reach 37 weeks of gestation (gestation is the period during which a baby develops in its mother). Nowadays in the US, for example, more than half a million babies arrive earlier than expected every year (1 in 8 babies). Although improvements in the care of newborn babies (neonatal care) mean that preterm babies are more likely to survive than in the past, preterm birth remains the single biggest cause of infant death in many developed countries, and many preterm babies who survive have long-term health problems and disabilities, particularly those born before 32 weeks of gestation. Preterm births can be spontaneous or medically induced. At present, it impossible to predict which mothers will spontaneously deliver early and there is no effective way to prevent these preterm births; medically induced early labor is undertaken when either the unborn baby or mother would be at risk if the pregnancy continued to full term.
Why Was This Study Done?
Preterm birth rates need to be reduced, but before this can be done it is important to know how the causes of preterm birth, the numbers of preterm stillbirths, and the numbers of preterm babies who die at birth (neonatal deaths) or soon after (perinatal deaths) are changing with time. If, for example, the rise in preterm births is mainly due to an increase in medically induced labor and if this change in practice has reduced neonatal deaths, it would be unwise to try to reduce the preterm birth rate by discouraging medically induced preterm births. So far, data from the US and Latin America suggest that the increase in preterm births in these countries is solely due to increased rates of medically induced preterm births. However, in Europe and Australia, the rate of spontaneous preterm births also seems to be increasing. In this study, the researchers examine the trends over time and causes of preterm birth and of neonatal death and illness in Scotland over a 25-year period.
What Did the Researchers Do and Find?
By searching a Scottish database of linked maternity records and infant health and death records, the researchers identified 1.49 million singleton births that occurred between 1980 and 2004 of which nearly 90,000 were preterm births. Over the study period, the rates of spontaneous and of medically induced preterm births per 1,000 births increased by 10.7% and 41.2%, respectively, but because there were more spontaneous preterm births than medically induced preterm births, the absolute increase in the rates of each type of birth was similar. Several maternal complications including preeclampsia (a condition that causes high blood pressure) and placenta previa (covering of the opening of the cervix by the placenta) played a decreasing role in preterm births over the study period, whereas gestational and preexisting diabetes played an increasing role. Finally, there was a decline in stillbirths and in neonatal and perinatal deaths among preterm babies, although more babies remained in the hospital longer than 7 days after birth. More specifically, after 28 weeks of gestation, stillbirths and perinatal deaths decreased among medically induced preterm births but not among spontaneous preterm births.
What Do These Findings Mean?
These findings indicate that in Scotland between 1980 and 2004, increases in spontaneous and medically induced preterm births contributed equally to the rising rate of preterm births. Importantly, they also show that the increase in induced preterm births helped to reduce stillbirths and neonatal and perinatal deaths, a finding that supports the criteria that clinicians currently use to decide whether to induce an early birth. Nevertheless, preterm births still account for two-thirds of all stillbirths, neonatal deaths, and extended neonatal stays in hospital and thus cause considerable suffering and greatly increase the workload in neonatal units. The rates of such births consequently need to be reduced and, for Scotland at least, ways will have to be found to reduce the rates of both spontaneous and induced preterm births to achieve this goal while continuing to identify those sick babies who need to be delivered early to give them the best chance of survival.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000153
Tommys is a nonprofit organization that funds research and provides information on the causes and prevention of miscarriage, premature birth, and stillbirth
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on preterm birth (in English and Spanish)
The Nemours Foundation, another nonprofit organization for child health, also provides information on premature babies (in English and Spanish)
The US Centers for Disease Control and Prevention provides information on maternal and infant health (in English and Spanish)
The US National Women's Health Information Center has detailed information about pregnancy, including a section on pregnancy complications
MedlinePlus provides links to other information on premature babies and to information on pregnancy (in English and Spanish)
doi:10.1371/journal.pmed.1000153
PMCID: PMC2740823  PMID: 19771156
6.  Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol 
Reproductive Health  2010;7:14.
Background
Spontaneous preterm deliveries that occur before the 34th week of gestation, and particularly before the 32nd week of gestation, have been strongly associated to intrauterine infection, ascending from vagina, and represent the largest portion of neonatal deaths and neurological problems. Bacterial vaginosis, characterized by a diminished or absent flora of lactobacilli and increased colonization of several anaerobic or facultative microorganisms, increases two times the risk of preterm delivery before the 34th week. Trials of antibiotics failed to show efficacy and effectiveness against spontaneous preterm birth related to bacterial vaginosis. Some studies indicate benefit from selected probiotics to treat genitourinary infections, including bacterial vaginosis.
Objective
The purpose of this study is to evaluate the effectiveness of the early administration of selected probiotics to pregnant women with asymptomatic bacterial vaginosis/intermediate degree infection to reduce the occurrence of spontaneous preterm delivery and related neonatal mortality and morbidity.
Methods/Design
Women attending public prenatal care services in Rio de Janeiro will be screened to select asymptomatic pregnant women, less than 20 weeks' gestation, with no indication of elective preterm delivery. Those with vaginal pH > = 4.5 and a Nugent score between 4 and 10 (intermediate degree infection or bacterial vaginosis) will be randomized to either the placebo or the intervention group, after written informed consent. Intervention consists in the use of probiotics, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, 2 capsules a day, each capsule containing more than one million bacilli of each strain, for 6-12 weeks, up to the 24th-25th wk of gestation. Ancillary analyses include quantification of selected cervicovaginal cytokines and genotyping of selected polymorphisms. The randomization process is stratified for history of preterm delivery and blocked. Allocation concealment was designed as well as blinding of women, caregivers and outcome evaluators. The study will be supervised by an independent monitoring committee. Outcomes under study are preterm delivery (< 34- < 32 weeks of gestation) and associated neonatal complications: early neonatal sepsis, bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, and prematurity-related retinopathy; definitions were adapted from those recommended by the 2002 version of the Vermont-Oxford Network. Trial registration at NIH register: NCT00303082.
doi:10.1186/1742-4755-7-14
PMCID: PMC2911410  PMID: 20591191
7.  Clinical Benefits, Costs, and Cost-Effectiveness of Neonatal Intensive Care in Mexico 
PLoS Medicine  2010;7(12):e1000379.
Joshua Salomon and colleagues performed a cost-effectiveness analysis using health and economic outcomes following preterm birth in Mexico and showed that neonatal intensive care provided high value for the money in this setting.
Background
Neonatal intensive care improves survival, but is associated with high costs and disability amongst survivors. Recent health reform in Mexico launched a new subsidized insurance program, necessitating informed choices on the different interventions that might be covered by the program, including neonatal intensive care. The purpose of this study was to estimate the clinical outcomes, costs, and cost-effectiveness of neonatal intensive care in Mexico.
Methods and Findings
A cost-effectiveness analysis was conducted using a decision analytic model of health and economic outcomes following preterm birth. Model parameters governing health outcomes were estimated from Mexican vital registration and hospital discharge databases, supplemented with meta-analyses and systematic reviews from the published literature. Costs were estimated on the basis of data provided by the Ministry of Health in Mexico and World Health Organization price lists, supplemented with published studies from other countries as needed. The model estimated changes in clinical outcomes, life expectancy, disability-free life expectancy, lifetime costs, disability-adjusted life years (DALYs), and incremental cost-effectiveness ratios (ICERs) for neonatal intensive care compared to no intensive care. Uncertainty around the results was characterized using one-way sensitivity analyses and a multivariate probabilistic sensitivity analysis. In the base-case analysis, neonatal intensive care for infants born at 24–26, 27–29, and 30–33 weeks gestational age prolonged life expectancy by 28, 43, and 34 years and averted 9, 15, and 12 DALYs, at incremental costs per infant of US$11,400, US$9,500, and US$3,000, respectively, compared to an alternative of no intensive care. The ICERs of neonatal intensive care at 24–26, 27–29, and 30–33 weeks were US$1,200, US$650, and US$240, per DALY averted, respectively. The findings were robust to variation in parameter values over wide ranges in sensitivity analyses.
Conclusions
Incremental cost-effectiveness ratios for neonatal intensive care imply very high value for money on the basis of conventional benchmarks for cost-effectiveness analysis.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Most pregnancies last about 40 weeks but increasing numbers of babies are being born preterm, before they reach 37 weeks of gestation (the period during which a baby develops in its mother). In developed countries and some middle-income countries such as Mexico, improvements in the care of newborn babies (neonatal intensive care) mean that more preterm babies survive now than in the past. Nevertheless, preterm birth is still a major cause of infant death worldwide that challenges attainment of Target 5 of Millennium Development Goal 4—the reduction of the global under-five mortality rate by two-thirds of the 1990 rate by 2015 (the Millennium Development Goals, which were agreed by world leaders in 2000, aim to reduce world poverty). Furthermore, many preterm babies who survive have long-term health problems and disabilities such as cerebral palsy, deafness, or learning difficulties. The severity of these disabilities and their long-term costs to families and to society depend on the baby's degree of prematurity.
Why Was This Study Done?
Mexico recently reformed its health system in an effort to improve access to care, particularly for the poorest sections of its population, and to improve the quality of its health care. The central component of this health care reform is the System of Social Protection of Health (SSPH). The SSPH contains a family health insurance program—Seguro Popular—that aims to provide the 50 million uninsured people living in Mexico with free access to an explicit set of health care interventions. As with any insurance program, decisions have to be made about which interventions Seguro Poplar should cover. Should neonatal intensive care be covered, for example? Do the benefits of this intervention (increased survival of babies) outweigh the costs of neonatal care and of long-term care for survivors with disabilities? In other words, is neonatal intensive care cost-effective? In this study, the researchers investigate this question by estimating the clinical benefits, costs, and cost-effectiveness of neonatal intensive care in Mexico.
What Did the Researchers Do and Find?
The researchers built a decision analytic model, a mathematical model that combines evidence on the outcomes and costs of alternative treatments to help inform decisions about health care policy. They gathered data about the health outcomes of preterm births in Mexico from registers of births and deaths and from hospital discharge databases, and estimated the costs of neonatal intensive care and long-term care for disabled survivors using data from the Mexican Ministry of Health and the World Health Organization. They then applied their model, which estimates changes in parameters such as life expectancy, lifetime costs, disability-adjusted life years (DALYs; one DALY represents the loss of a year of healthy life), and incremental cost-effectiveness ratios (ICERs; the additional cost expended for each DALY averted) for neonatal intensive care compared to no intensive care, to a group of 2 million infants. Neonatal intensive care for infants born at 24–26, 27–29, and 30–33 weeks gestation prolonged life expectancy by 28, 43, and 34 years and averted 9, 15, and 12 DALYs at incremental costs of US$11,000, US$10,000, and US$3000, respectively, compared to no intensive care. The ICERs of neonatal intensive care for babies born at these times were US$1200, US$700, and US$300 per DALY averted, respectively.
What Do These Findings Mean?
Interventions with ICERs of less than a country's per capita gross domestic product (GDP) are highly cost-effective; those with ICERs of 1–3 times the per capita GDP are potentially cost-effective. Mexico's per capita GDP in 2005 was approximately US$8,200. Thus, neonatal intensive care could provide exceptional value for money in Mexico (and maybe in other middle-income countries), even for very premature babies. The accuracy of these findings inevitably depends on the assumptions used to build the decision analytic model and on the accuracy of the data fed into it, but the findings were little changed by a wide range of alterations that the researchers made to the model. Importantly, however, this cost-effectiveness analysis focuses on health and economic consequences of different intervention choices, and does not capture all aspects of well-being. Decisions regarding neonatal intensive care will need to be based on a full consideration of all relevant factors, including ethical issues, and cost-effectiveness analyses should continue to be updated as new data emerge on health outcomes and costs associated with neonatal intensive care.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000379.
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on preterm birth (in English and Spanish)
The Nemours Foundation, another nonprofit organization for child health, also provides information on premature babies (in English and Spanish)
MedlinePlus provides links to other information on premature babies (in English and Spanish)
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development and protection around the world; it provides information on Millennium Development Goal 4 and its Childinfo website provides detailed statistics about child survival and health (some information in several languages)
A PLoS Medicine Policy Forum by Núria Homedes and Antonio Ugalde discusses health care reforms in Mexico
doi:10.1371/journal.pmed.1000379
PMCID: PMC3001895  PMID: 21179496
8.  Multiple pregnancies and its relationship with the development of retinopathy of prematurity (ROP) 
Background
The influence of multiple gestation on the occurrence of retinopathy of prematurity (ROP) is still not completely understood.
Objectives
To verify the incidence of any stage of ROP and threshold ROP in singletons and in multiple gestation among preterm infants.
Methods
This was an institutional, prospective, and descriptive cohort study, which included preterm newborns with birth weight (BW) of 1500 g or less and/or gestational age (GA) of 32 weeks or less, as admitted to the neonatal units at Laranjeiras and Amparo Hospitals in Rio de Janeiro, Brazil, between January 2001 and July 2005, and whom remained hospitalized for at least 28 days. There were no exclusion criteria. Patients were divided into two groups: Group 1 included multiples; and Group 2 consisted of singletons.
Results
A total of 159 infants that remained in neonatal unit care for at least 28 days were included in this study. Group 1 comprised 56 (35%) multiples; and Group 2 comprised 103 (65%) singletons. Mean BW was 1072 g ± 272 and 1089 g ± 282 in Groups 1 and 2, respectively (analysis of variance [ANOVA] P > 0.05). Mean GA among multiple gestation (Group 1) was 29 weeks ± 2.1; and 29 weeks ± 2.4 among singletons (Group 2) (ANOVA P > 0.05). Days in oxygen therapy ranged from 0 to 188 days. Median among Group 1 was 15 days, while median in Group 2 was 10 days (Kruskal–Wallis P > 0.05). Any stage ROP was detected in 66 (41.5%) of the whole cohort comprising 159 babies. Among the 56 multiples, 30 (53.6%) achieved any stage ROP, and among 103 singletons, 36 (35%) achieved any stage ROP (Chi-square test P < 0.05). Threshold ROP occurred in 12 (7.5%) of the 159 patients included. Three (5.3%) patients from Group 1 and nine (8.7%) patients in Group 2 reached threshold ROP needing laser treatment (Fisher’s exact test P > 0.05).
Conclusion
This study showed higher frequency of any stage of ROP in twins and triplets but not regarding threshold disease. Because of the relatively small number of patients in this sample, other studies are necessary to determine if gemelarity plays a role in the occurrence of ROP.
doi:10.2147/OPTH.S25431
PMCID: PMC3258087  PMID: 22267912
prematurity; retinopathy of prematurity; gemelarity; prevalence
9.  A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results 
Trials  2011;12:239.
Background
Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation.
Objective
The purpose of this study was to evaluate the efficacy of the early administration of selected lactobacilli strains (probiotics) to pregnant women with asymptomatic bacterial vaginosis/intermediate-degree infections to prevent spontaneous premature delivery and associated neonatal morbidity.
Methods/Design
Asymptomatic pregnant women at less than 20 weeks of gestation, with no indication of elective preterm delivery, with a vaginal pH ≥ 4.5 and Nugent score > 3 were randomly assigned to the placebo or intervention group (oral administration of selected lactobacilli up to the 24th to 26th week of gestation). The randomisation was stratified for the history of premature delivery (HPD) and blocked. The allocation was concealed, and the participating health professionals and patients were blinded. The primary outcome was preterm delivery (<34 to <32 weeks), and the secondary outcomes were associated neonatal complications.
Results
In total, 4,204 pregnant women were screened; 320 and 324 individuals were respectively randomly assigned to the placebo and intervention groups, and 62% finished the trial. None of the randomised patients were lost to follow-up. For the non-HPD stratum, the intent-to-treat relative risks of spontaneous premature birth at < 34 and < 37 weeks' gestation were 0.33 (0.03, 3.16) and 0.49 (0.17, 1.44), respectively, and they were non-significant (ns) with p = 0.31 and 0.14. The corresponding actual treatment figures were zero and 0.32 (0.09, 1.19), which were ns with p = 0.12 and 0.06. The intent-to-treat relative risk of spontaneous premature birth at < 37 weeks of gestation for the trial as a whole, including HPD and non-HPD participants, was 0.69 (0.26, 1.78), p = 0.30 (ns). The neonatal complications under evaluation occurred in only one infant (< 34 weeks; placebo group) who presented with respiratory distress syndrome and suspected early neonatal sepsis. The recorded adverse events were minor and relatively non-specific.
Conclusions
The efficacy of the tested probiotics to prevent preterm delivery among women without a history of preterm delivery was not determined because the study sample was insufficient to estimate statistically significant intent-to-treat effects; additional studies are needed to evaluate this intervention among these women.
Trial registration
Trial registration at NIH register: NCT00303082. Sources of funding: the Brazilian Health Ministry and the State of Rio de Janeiro Research Foundation.
doi:10.1186/1745-6215-12-239
PMCID: PMC3264514  PMID: 22059409
spontaneous preterm delivery; prevention; randomised controlled parallel-group trial; probiotics; history of preterm delivery
10.  Haemoglobin level at birth is associated with short term outcomes and mortality in preterm infants 
BMC Medicine  2015;13:16.
Background
Blood volume and haemoglobin (Hb) levels are increased by delayed umbilical cord clamping, which has been reported to improve clinical outcomes of preterm infants. The objective was to determine whether Hb level at birth was associated with short term outcomes in preterm infants born at ≤32 weeks gestation.
Methods
Data were collected retrospectively from electronic records: Standardised Electronic Neonatal Database, Electronic Patient Record, Pathology (WinPath), and Blood Bank Electronic Database. The study was conducted in a tertiary perinatal centre with around 5,500 deliveries and a neonatal unit admission of 750 infants per year. All inborn preterm infants of 23 to 32 weeks gestational age (GA) admitted to the neonatal unit from January 2006 to September 2012 were included.
The primary outcomes were intra-ventricular haemorrhage, necrotising entero-colitis, broncho-pulmonary dysplasia, retinopathy of prematurity, and death before discharge. The secondary outcomes were receiving blood transfusion and length of intensive care and neonatal unit days. The association between Hb level (g/dL) at birth and outcomes was analysed by multiple logistic regression adjusting for GA and birth weight (BWt).
Results
Overall, 920 infants were eligible; 28 were excluded because of missing data and 2 for lethal congenital malformation. The mean (SD) GA was 28.3 (2.7) weeks, BWt was 1,140 (414) g, and Hb level at birth was 15.8 (2.6) g/dL.
Hb level at birth was significantly associated with all primary outcomes studied (P <0.001) in univariate analyses. Once GA and BWt were adjusted for, only death before discharge remained statistically significant; the OR of death for infants with Hb level at birth <12 g/dL compared with those with Hb level at birth of ≥18 g/dL was 4.1 (95% CI, 1.4–11.6). Hb level at birth was also significantly associated with blood transfusion received (P <0.01) but not with duration of intensive care or neonatal unit days.
Conclusions
Low Hb level at birth was significantly associated with mortality and receiving blood transfusion in preterm infants born at ≤32 weeks gestation. Further studies are needed to determine the association between Hb level at birth and long-term neurodevelopmental outcomes.
Electronic supplementary material
The online version of this article (doi:10.1186/s12916-014-0247-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s12916-014-0247-6
PMCID: PMC4307132  PMID: 25622597
Haemoglobin; Mortality; Outcome; Preterm
11.  Community Mobilization in Mumbai Slums to Improve Perinatal Care and Outcomes: A Cluster Randomized Controlled Trial 
PLoS Medicine  2012;9(7):e1001257.
David Osrin and colleagues report findings from a cluster-randomized trial conducted in Mumbai slums; the trial aimed to evaluate whether facilitator-supported women's groups could improve perinatal outcomes.
Introduction
Improving maternal and newborn health in low-income settings requires both health service and community action. Previous community initiatives have been predominantly rural, but India is urbanizing. While working to improve health service quality, we tested an intervention in which urban slum-dweller women's groups worked to improve local perinatal health.
Methods and Findings
A cluster randomized controlled trial in 24 intervention and 24 control settlements covered a population of 283,000. In each intervention cluster, a facilitator supported women's groups through an action learning cycle in which they discussed perinatal experiences, improved their knowledge, and took local action. We monitored births, stillbirths, and neonatal deaths, and interviewed mothers at 6 weeks postpartum. The primary outcomes described perinatal care, maternal morbidity, and extended perinatal mortality. The analysis included 18,197 births over 3 years from 2006 to 2009. We found no differences between trial arms in uptake of antenatal care, reported work, rest, and diet in later pregnancy, institutional delivery, early and exclusive breastfeeding, or care-seeking. The stillbirth rate was non-significantly lower in the intervention arm (odds ratio 0.86, 95% CI 0.60–1.22), and the neonatal mortality rate higher (1.48, 1.06–2.08). The extended perinatal mortality rate did not differ between arms (1.19, 0.90–1.57). We have no evidence that these differences could be explained by the intervention.
Conclusions
Facilitating urban community groups was feasible, and there was evidence of behaviour change, but we did not see population-level effects on health care or mortality. In cities with multiple sources of health care, but inequitable access to services, community mobilization should be integrated with attempts to deliver services for the poorest and most vulnerable, and with initiatives to improve quality of care in both public and private sectors.
Trial registration
Current Controlled Trials ISRCTN96256793
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Substantial progress is being made to reduce global child mortality (deaths of children before the age of 5 years) and maternal mortality (deaths among women because of complications of pregnancy and childbirth)—two of the Millennium Development Goals agreed by world leaders in 2000 to end extreme poverty. Even so, worldwide, in 2010, 7.6 million children died before their fifth birthday and there were nearly 360,000 maternal deaths. Almost all child and maternal deaths occur in developing countries—a fifth of under-five deaths and more than a quarter of neonatal deaths (deaths during the first month of life, which account for two-fifths of all child deaths) occur in India alone. Moreover, most child and maternal deaths are caused by avoidable conditions. Specifically, the major causes of neonatal death—complications of preterm delivery, breathing problems during or after delivery, and infections of the blood (sepsis) and lungs (pneumonia)—and of maternal deaths—hemorrhage (abnormal bleeding), sepsis, unsafe abortion, obstructed labor, and hypertensive diseases of pregnancy—could all be largely prevented by improved access to reproductive health services and skilled health care workers.
Why Was This Study Done?
Experts believe that improvements to maternal and newborn health in low-income settings require both health service strengthening and community action. That is, the demand for better services, driven by improved knowledge about maternal and newborn health (perinatal issues), has to be increased in parallel with the supply of those services. To date, community mobilization around perinatal issues has largely been undertaken in rural settings but populations in developing countries are becoming increasingly urban. In India, for example, 30% of the population now lives in cities. In this cluster randomized controlled trial (a study in which groups of people are randomly assigned to receive alternative interventions and the outcomes in the differently treated “clusters” are compared), City Initiative for Newborn Health (CINH) researchers investigate the effect of an intervention designed to help women's groups in the slums of Mumbai work towards improving local perinatal health. The CINH aims to improve maternal and newborn health in slum communities by improving public health care provision and by working with community members to improve maternal and newborn care practices and care-seeking behaviors.
What Did the Researchers Do and Find?
The researchers enrolled 48 Mumbai slum communities of at least 1,000 households into their trial. In each of the 24 intervention clusters, a facilitator supported local women's groups through a 36-meeting learning cycle during which group members discussed their perinatal experiences, improved their knowledge, and took action. To measure the effect of the intervention, the researchers monitored births, stillbirths, and neonatal deaths in all the clusters and interviewed mothers 6 weeks after delivery. During the 3-year trial, there were 18,197 births in the participating settlements. The women in the intervention clusters were enthusiastic about acquiring new knowledge and made substantial efforts to reach out to other women but were less successful in undertaking collective action such as negotiations with civic authorities for more amenities. There were no differences between the intervention and control communities in the uptake of antenatal care, reported work, rest, and diet in late pregnancy, institutional delivery, or in breast feeding and care-seeking behavior. Finally, the combined rate of stillbirths and neonatal deaths (the extended perinatal mortality rate) was the same in both arms of the trial, as was maternal mortality.
What Do These Findings Mean?
These findings indicate that it is possible to facilitate the discussion of perinatal health care by urban women's groups in the challenging conditions that exist in the slums of Mumbai. However, they fail to show any measureable effect of community mobilization through the facilitation of women's groups on perinatal health at the population level. The researchers acknowledge that more intensive community activities that target the poorest, most vulnerable slum dwellers might produce measurable effects on perinatal mortality, and they conclude that, in cities with multiple sources of health care and inequitable access to services, it remains important to integrate community mobilization with attempts to deliver services to the poorest and most vulnerable, and with initiatives to improve the quality of health care in both the public and private sector.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001257.
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development, and protection around the world; it provides information on the reduction of child mortality (Millennium Development Goal 4); its Childinfo website provides information about all the Millennium Development Goals and detailed statistics about on child survival and health, newborn care, and maternal health (some information in several languages)
The World Health Organization also has information about Millennium Development Goal 4 and Millennium Development Goal 5, the reduction of maternal mortality, provides information on newborn infants, and provides estimates of child mortality rates (some information in several languages)
Further information about the Millennium Development Goals is available
Information on the City Initiative for Newborn Health and its partners and a detailed description of its trial of community mobilization in Mumbai slums to improve care during pregnancy, delivery, postnatally and for the newborn are available
Further information about the Society for Nutrition, Education and Health Action (SNEHA) is available
doi:10.1371/journal.pmed.1001257
PMCID: PMC3389036  PMID: 22802737
12.  Touch and Massage for Medically Fragile Infants 
Research investigating the efficacy of infant massage has largely focused on premature and low birth weight infants. The majority of investigations have neglected highly acute patients in academic neonatal intensive care units (NICUs). The current study was developed with two aims: (Phase 1) to develop, implement and demonstrate the feasibility and safety of a parent-trained compassionate touch/massage program for infants with complex medical conditions and (Phase 2) to conduct a longitudinal randomized control trial (RCT) of hand containment/massage versus standard of care in a level III academic Center for Newborn and Infant Critical Care (CNICC). Certified infant massage instructors (CIMIs) taught parents to massage their hospitalized infants. Massage therapy and instruction were performed for seven consecutive days and health outcomes were collected for up to 1 month following treatment. Caregivers, nurses and certified infant massage therapists indicated moderate to high levels of satisfaction and feasibility with the implementation of hand containment/massage in a level III academic center CNICC. In addition, infant behavioral and physiological measures were within safe limits during the massage sessions. All caregivers participating in the massage group reported high levels of satisfaction 7 days into the intervention and at the 1-month follow-up with regards to their relationship with their infant, the massage program's impact on that relationship and the massage program. Due to unequal and small sample sizes, between group analyses (control versus massage) were not conducted. Descriptive infant characteristics of health outcomes are described. Preliminary data from this study indicates feasibility and safety of infant massage and satisfaction among the caregivers, CIMIs and the nurses in the CNICC. An important contribution from this study was the demonstration of the infants’ safety based on physiological stability and no change in agitation/pain scores of the infants receiving massage. Massage in a tertiary urban academic NICU continues to be an area of needed study. Future studies examining infant health outcomes, such as weight gain, decreased length of hospitalization and caregiver–infant bonding, would provide greater insight into the impact of massage for medically fragile infants.
doi:10.1093/ecam/nem076
PMCID: PMC2781772  PMID: 18955228
medically fragile; infant massage; neonatal intensive care; caregiver depression; pediatric psychology; CAM; integrative medicine
13.  Antenatal Syphilis Screening Using Point-of-Care Testing in Sub-Saharan African Countries: A Cost-Effectiveness Analysis 
PLoS Medicine  2013;10(11):e1001545.
Yukari Manabe and colleagues evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in sub-Saharan Africa and estimate the impact of universal screening on averted stillbirths, neonatal deaths, congenital syphilis, and DALYs.
Please see later in the article for the Editors' Summary
Background
Untreated syphilis in pregnancy is associated with adverse clinical outcomes for the infant. Most syphilis infections occur in sub-Saharan Africa (SSA), where coverage of antenatal screening for syphilis is inadequate. Recently introduced point-of-care syphilis tests have high accuracy and demonstrate potential to increase coverage of antenatal screening. However, country-specific cost-effectiveness data for these tests are limited. The objective of this analysis was to evaluate the cost-effectiveness and budget impact of antenatal syphilis screening for 43 countries in SSA and estimate the impact of universal screening on stillbirths, neonatal deaths, congenital syphilis, and disability-adjusted life years (DALYs) averted.
Methods and Findings
The decision analytic model reflected the perspective of the national health care system and was based on the sensitivity (86%) and specificity (99%) reported for the immunochromatographic strip (ICS) test. Clinical outcomes of infants born to syphilis-infected mothers on the end points of stillbirth, neonatal death, and congenital syphilis were obtained from published sources. Treatment was assumed to consist of three injections of benzathine penicillin. Country-specific inputs included the antenatal prevalence of syphilis, annual number of live births, proportion of women with at least one antenatal care visit, per capita gross national income, and estimated hourly nurse wages. In all 43 sub-Saharan African countries analyzed, syphilis screening is highly cost-effective, with an average cost/DALY averted of US$11 (range: US$2–US$48). Screening remains highly cost-effective even if the average prevalence falls from the current rate of 3.1% (range: 0.6%–14.0%) to 0.038% (range: 0.002%–0.113%). Universal antenatal screening of pregnant women in clinics may reduce the annual number of stillbirths by up to 64,000, neonatal deaths by up to 25,000, and annual incidence of congenital syphilis by up to 32,000, and avert up to 2.6 million DALYs at an estimated annual direct medical cost of US$20.8 million.
Conclusions
Use of ICS tests for antenatal syphilis screening is highly cost-effective in SSA. Substantial reduction in DALYs can be achieved at a relatively modest budget impact. In SSA, antenatal programs should expand access to syphilis screening using the ICS test.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Syphilis is a sexually transmitted infection caused by a bacterium called Treponema pallidum. In many countries, the screening and treatment program for syphilis in pregnancy is inadequate, leading to babies being affected. It is estimated that between 2.5% and 17% of pregnant women in sub-Saharan Africa are infected with syphilis; recent estimates suggest that more than 535,000 pregnancies occur in women with active syphilis each year. Maternal syphilis in pregnancy has been estimated to cause approximately half a million adverse outcomes in babies, including stillbirths, neonatal deaths, preterm or low-birth-weight babies, and congenital infections. If a pregnant woman is tested, and given penicillin if positive, then many of these harmful outcomes can be avoided. The best time to screen and treat is in the first half of pregnancy.
Until recently, tests for syphilis were done in a laboratory as an enzyme immunoassay, requiring technical staff. Recently, rapid tests for syphilis became available for use at the point of care. There are considerable advantages to this approach: the tests can be undertaken using a finger prick to obtain a small amount of blood, and require minimal staff training and no specialist laboratory equipment. A result can be given within minutes, avoiding the need for a return visit in settings where antenatal care is infrequent.
Why Was This Study Done?
Although the advantages to the mother and baby of testing seem clear, the cost-effectiveness of a screening and treatment program using rapid point-of-care tests has not previously been assessed for most sub-Saharan African countries. The program has the greatest potential value in settings where syphilis is common. In local guidelines, testing is often recommended, but uncertainty over the costs and technical requirements has meant that antenatal syphilis screening has not been comprehensively introduced. The aim of this study was to assess whether antenatal syphilis screening was cost-effective for 43 countries in sub-Saharan Africa by estimating the extent of infant mortality and disability that could be prevented if maternal syphilis was diagnosed and treated.
What Did the Researchers Do and Find?
The researchers created a model that allowed them to determine the cost-effectiveness of antenatal syphilis screening and treatment. They included many factors including the performance of the test, how common syphilis is in each country, the number of births, the likelihood of harmful outcomes, the effectiveness of penicillin therapy, the cost of an antenatal visit, and the cost of the test and the penicillin treatment, if positive. Then they calculated how many deaths and how much disability could be prevented by screening and treatment. The results were expressed in disability-adjusted life years (DALYs), which give the number of years affected by ill health, disability, or early death. The study found that screening was highly cost-effective, with each DALY prevented on average costing only US$11.
What Do These Findings Mean?
Across sub-Saharan Africa, only about 40% of women are screened for syphilis during one of their antenatal care visits. These findings suggest that it would be an efficient use of health care resources to scale up antenatal screening programs for syphilis using the rapid point-of-care test. Comparing these results to those for other health care interventions in resource-limited settings suggests that screening pregnant women for syphilis in sub-Saharan Africa could achieve a substantial improvement in public health at relatively little cost. The researchers propose that combining HIV and syphilis tests into one antenatal screening package could be an efficient way of introducing a care package into settings where uptake is currently limited.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001545.
The World Health Organization provides information on syphilis in pregnant women
The London School of Hygiene & Tropical Medicine has information on efforts to reduce congenital syphilis and a rapid syphilis test toolkit
The US Centers for Disease Control and Prevention's STD Curriculum includes materials on syphilis
doi:10.1371/journal.pmed.1001545
PMCID: PMC3818163  PMID: 24223524
14.  A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality 
Trials  2010;11:88.
Background
The UN Millennium Development Goals call for substantial reductions in maternal and child mortality, to be achieved through reductions in morbidity and mortality during pregnancy, delivery, postpartum and early childhood. The MaiMwana Project aims to test community-based interventions that tackle maternal and child health problems through increasing awareness and local action.
Methods/Design
This study uses a two-by-two factorial cluster-randomised controlled trial design to test the impact of two interventions. The impact of a community mobilisation intervention run through women's groups, on home care, health care-seeking behaviours and maternal and infant mortality, will be tested. The impact of a volunteer-led infant feeding and care support intervention, on rates of exclusive breastfeeding, uptake of HIV-prevention services and infant mortality, will also be tested. The women's group intervention will employ local female facilitators to guide women's groups through a four-phase cycle of problem identification and prioritisation, strategy identification, implementation and evaluation. Meetings will be held monthly at village level. The infant feeding intervention will select local volunteers to provide advice and support for breastfeeding, birth preparedness, newborn care and immunisation. They will visit pregnant and new mothers in their homes five times during and after pregnancy.
The unit of intervention allocation will be clusters of rural villages of 2500-4000 population. 48 clusters have been defined and randomly allocated to either women's groups only, infant feeding support only, both interventions, or no intervention. Study villages are surrounded by 'buffer areas' of non-study villages to reduce contamination between intervention and control areas. Outcome indicators will be measured through a demographic surveillance system. Primary outcomes will be maternal, infant, neonatal and perinatal mortality for the women's group intervention, and exclusive breastfeeding rates and infant mortality for the infant feeding intervention.
Structured interviews will be conducted with mothers one-month and six-months after birth to collect detailed quantitative data on care practices and health-care-seeking. Further qualitative, quantitative and economic data will be collected for process and economic evaluations.
Trial registration
ISRCTN06477126
doi:10.1186/1745-6215-11-88
PMCID: PMC2949851  PMID: 20849613
15.  Retinopathy of prematurity and risk factors: a prospective cohort study 
BMC Pediatrics  2005;5:18.
Background
Increased survival of extremely low birth infants due to advances in antenatal and neonatal care has resulted in a population of infants at high risk of developing retinopathy of prematurity (ROP). Therapeutic interventions include the use of antenatal and postnatal steroids however, their effects on the severity of ROP is in dispute. In addition, it has not been investigated whether severe ROP is due to therapeutic interventions or due to the severity of illness. The aim of the present study was to assess the association between the incidence of severe retinopathy of prematurity (greater than stage 2 – International classification of ROP) and mechanical ventilation, oxygen therapy, gestational age, antenatal and postnatal steroids in extremely low birth weight infants.
Methods
Neonates admitted to the neonatal intensive care unit in Lansing, Michigan, during 1993–2000 were followed to determine factors influencing the development of severe retinopathy of prematurity. Ophthalmologic examinations were started at 6 weeks and followed until resolution. We used logistic regression to estimate the relative risk (odds ratio) associated with risk factors of ROP.
Results
Of the neonates with ≤ 1500 g birth weight, admitted to the neonatal intensive care unit, 85% (616/725) survived. Severe retinopathy of prematurity was detected in 7.8% of 576 neonates who had eye examinations. Neonates of lower gestational age (≤ 25 weeks and 26–28 weeks) had an increased odds ratio of 8.49 and 3.19 for the development of severe retinopathy of prematurity, respectively, compared to those 29 weeks and older. Late postnatal steroid treatment starting after 3 weeks of life showed 2.9-fold increased odds ratio, in particular administration for two weeks and more (OR: 4.09, 95% CI: 1.52–11.03). With increasing antenatal steroids courses the risk of severe retinopathy of prematurity decreased, however, it was not significant. Lower gestational age, dependence on ventilation, and use of postnatal steroids were intertwined. Simultaneous presence of these factors seems to indicate severe disease status.
Conclusion
Prolonged and late postnatal steroids treatment in very low birth weight infants may pose an increased risk for the development of severe retinopathy of prematurity; however, use of postnatal steroids may also be a marker for severity of illness. Further studies need to focus on biologic markers in the pathogenesis of retinopathy of prematurity and to better understand the influence of therapies.
doi:10.1186/1471-2431-5-18
PMCID: PMC1175091  PMID: 15985170
16.  Demographics, clinical characteristics and neonatal outcomes in a rural Ugandan NICU 
Background
Ninety-six percent of the world’s 3 million neonatal deaths occur in developing countries where the majority of births occur outside of a facility. Community-based approaches to the identification and management of neonatal illness have reduced neonatal mortality over the last decade. To further expand life-saving services, improvements in access to quality facility-based neonatal care are required. Evaluation of rural neonatal intensive care unit referral centers provides opportunities to further understand determinants of neonatal mortality in developing countries. Our objective was to describe demographics, clinical characteristics and outcomes from a rural neonatal intensive care unit (NICU) in central Uganda from 2005–2008.
Methods
The NICU at Kiwoko hospital serves as a referral center for three rural districts of central Uganda. For this cross sectional study we utilized a NICU clinical database that included admission information, demographics, and variables related to hospital course and discharge. Descriptive statistics are reported for all neonates (<28 days old) admitted to the NICU between December 2005 and September 2008, disaggregated by place of birth. Percentages reported are among neonates for which data on that indicator were available.
Results
There were 809 neonates admitted during the study period, 68% (490/717) of whom were inborn. The most common admission diagnoses were infection (30%, 208/699), prematurity (30%, 206/699), respiratory distress (28%, 198/699) and asphyxia (22%, 154/699). Survival to discharge was 78% (578/745). Mortality was inversely proportional to birthweight and gestational age (P-value test for trend <0.01). This was true for both inborn and outborn infants (p < 0.01). Outborn infants were more likely to be preterm (44%, (86/192) vs. 33%, (130/400), P-value <0.01) and to be low birthweight (58%, (101/173) vs. 40%, (190/479), P-value <0.01) than inborn infants. Outborn neonates had almost twice the mortality (33%, 68/208) as inborn neonates (17%, 77/456) (P-value <0.01).
Conclusions
Understanding determinants of neonatal survival in facilities is important for targeting improvements in facility based neonatal care and increasing survival in low and middle income countries.
doi:10.1186/1471-2393-14-327
PMCID: PMC4174605  PMID: 25234069
Millennium development goals; Neonatal mortality; Sick newborn care; Infant mortality; Low-resource settings; Global health; Birthweight; Gestational age; Low and Middle Income Countries
17.  Congenital diaphragmatic hernia in the preterm infant 
Surgery  2010;148(2):404-410.
Background
Congenital diaphragmatic hernia (CDH) remains a significant cause of death in newborns. With advances in neonatal critical care and ventilation strategies, survival in the term infant now exceeds 80% in some centers. Although prematurity is a significant risk factor for morbidity and mortality in most neonatal diseases, its associated risk with infants with CDH has been described poorly. We sought to determine the impact of prematurity on survival using data from the Congenital Diaphragmatic Hernia Registry (CDHR).
Methods
Prospectively collected data from live-born infants with CDH were analyzed from the CDHR from January 1995 to July 2009. Preterm infants were defined as <37 weeks estimated gestational age at birth. Univariate and multivariate logistic regression analysis were performed.
Results
During the study period, 5,069 infants with CDH were entered in the registry. Of the 5,022 infants with gestational age data, there were 3,895 term infants (77.6%) and 1,127 preterm infants (22.4%). Overall survival was 68.7%. A higher percentage of term infants were treated with extracorporeal membrane oxygenation (ECMO) (33% term vs 25.6% preterm). Preterm infants had a greater percentage of chromosomal abnormalities (4% term vs 8.1% preterm) and major cardiac anomalies (6.1% term vs 11.8% preterm). Also, a significantly higher percentage of term infants had repair of the hernia (86.3% term vs 69.4% preterm). Survival for infants that underwent repair was high in both groups (84.6% term vs 77.2% preterm). Survival decreased with decreasing gestational age (73.1% term vs 53.5% preterm). The odds ratio (OR) for death among preterm infants adjusted for patch repair, ECMO, chromosomal abnormalities, and major cardiac anomalies was OR 1.68 (95% confidence interval [CI], 1.34–2.11).
Conclusion
Although outcomes for preterm infants are clearly worse than in the term infant, more than 50% of preterm infants still survived. Preterm infants with CDH remain a high-risk group. Although ECMO may be of limited value in the extremely premature infant with CDH, most preterm infants that live to undergo repair will survive. Prematurity should not be an independent factor in the treatment strategies of infants with CDH.
doi:10.1016/j.surg.2010.03.018
PMCID: PMC3097021  PMID: 20471048
18.  Effect of Facilitation of Local Maternal-and-Newborn Stakeholder Groups on Neonatal Mortality: Cluster-Randomized Controlled Trial 
PLoS Medicine  2013;10(5):e1001445.
Lars Åke Persson and colleagues conduct a cluster randomised control in northern Vietnam to analyze the effect of the activity of local community-based maternal-and-newborn stakeholder groups on neonatal mortality.
Please see later in the article for the Editors' Summary
Background
Facilitation of local women's groups may reportedly reduce neonatal mortality. It is not known whether facilitation of groups composed of local health care staff and politicians can improve perinatal outcomes. We hypothesised that facilitation of local stakeholder groups would reduce neonatal mortality (primary outcome) and improve maternal, delivery, and newborn care indicators (secondary outcomes) in Quang Ninh province, Vietnam.
Methods and Findings
In a cluster-randomized design 44 communes were allocated to intervention and 46 to control. Laywomen facilitated monthly meetings during 3 years in groups composed of health care staff and key persons in the communes. A problem-solving approach was employed. Births and neonatal deaths were monitored, and interviews were performed in households of neonatal deaths and of randomly selected surviving infants. A latent period before effect is expected in this type of intervention, but this timeframe was not pre-specified. Neonatal mortality rate (NMR) from July 2008 to June 2011 was 16.5/1,000 (195 deaths per 11,818 live births) in the intervention communes and 18.4/1,000 (194 per 10,559 live births) in control communes (adjusted odds ratio [OR] 0.96 [95% CI 0.73–1.25]). There was a significant downward time trend of NMR in intervention communes (p = 0.003) but not in control communes (p = 0.184). No significant difference in NMR was observed during the first two years (July 2008 to June 2010) while the third year (July 2010 to June 2011) had significantly lower NMR in intervention arm: adjusted OR 0.51 (95% CI 0.30–0.89). Women in intervention communes more frequently attended antenatal care (adjusted OR 2.27 [95% CI 1.07–4.8]).
Conclusions
A randomized facilitation intervention with local stakeholder groups composed of primary care staff and local politicians working for three years with a perinatal problem-solving approach resulted in increased attendance to antenatal care and reduced neonatal mortality after a latent period.
Trial registration
Current Controlled Trials ISRCTN44599712
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Over the past few years, there has been enormous international effort to meet the target set by Millennium Development Goal 4 to reduce the under-five child mortality rate by two-thirds and to reduce the number of maternal deaths by three-quarters, respectively, from the 1990 level by 2015. There has been some encouraging progress and according to the latest figures from the World Health Organization, in 2011, just under 7 million children aged under 5 years died, a fall of almost 3 million from a decade ago. However, currently, 41% of all deaths among children under the age of 5 years occur around birth and the first 28 days of life (perinatal and neonatal mortality). Simple interventions can substantially reduce neonatal deaths and there have been several international, national, and local efforts to implement effective care packages to help reduce the number of neonatal deaths.
Why Was This Study Done?
In order for these interventions to be most effective, it is important that the local community becomes involved. Community mobilization, especially through local women's groups, can empower women to prioritize specific interventions to help improve their own health and that of their baby. An alternative strategy might be to mobilize people who already have responsibility to promote health and welfare in society, such as primary care staff, village health workers, and elected political representatives. However, it is unclear if the activities of such stakeholder groups result in improved neonatal survival. So in this study from northern Vietnam, the researchers analyzed the effect of the activity of local maternal-and-newborn stakeholder groups on neonatal mortality.
What Did the Researchers Do and Find?
Between 2008 and 2011, the researchers conducted a cluster-randomized controlled trial in 90 communes within the Quang Ninh province of northeast of Vietnam: 44 communes were allocated to intervention and 46 to the control. The local women's union facilitated recruitment to the intervention, local stakeholder groups (Maternal and Newborn Health Groups), which comprised primary care staff, village health workers, women's union representatives, and the person with responsibility for health in the commune. The groups' role was to identify and prioritize local perinatal health problems and implement actions to help overcome these problems.
Over the three-year period, the Maternal and Newborn Health Groups in the 44 intervention communes had 1,508 meetings. Every year 15–27 unique problems were identified and addressed 94–151 times. The problem-solving processes resulted in an annual number of 19–27 unique actions that were applied 297–649 times per year. The top priority problems and actions identified by these groups dealt with antenatal care attendance, post-natal visits, nutrition and rest during pregnancy, home deliveries, and breast feeding. Neonatal mortality in the intervention group did not change over the first two years but showed a significant improvement in the third year. The three leading causes of death were prematurity/low birth-weight (36%), intrapartum-related neonatal deaths (30%), and infections (15%). Stillbirth rates were 7.4 per 1,000 births in the intervention arm and 9.0 per 1,000 births in the control arm. There was one maternal death in the intervention communes and four in the control communes and there was a significant improvement in antenatal care attendance in the intervention arm. However, there were no significant differences between the intervention and control groups of other outcomes, including tetanus immunization, delivery preparedness, institutional delivery, temperature control at delivery, early initiation of breastfeeding, or home visit of a midwife during the first week after delivery.
What Do These Findings Mean?
These findings suggest that local stakeholder groups comprised of primary care staff and local politicians using a problem-solving approach may help to reduce the neonatal mortality rate after three years of implementation (although the time period for an expected reduction in neonatal mortality was not specified before the trial started) and may also increase the rate of antenatal care attendance. However, the intervention had no effect on other important outcomes such as the rate of institutional delivery and breast feeding. This study used a novel approach of community-based activity that was implemented into the public sector system at low cost. A further reduction in neonatal deaths around delivery might be achieved by neonatal resuscitation training and home visits to the mother and her baby.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001445.
The World Health Organization provides comprehensive statistics on neonatal mortality
The Healthy Newborn Network has information on community interventions to help reduce neonatal mortality from around the world
doi:10.1371/journal.pmed.1001445
PMCID: PMC3653802  PMID: 23690755
19.  The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial 
BMC Pediatrics  2012;12:76.
Background
Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG) is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour.
Methods/design
This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA), n = 70 moderate term infants (32–37 weeks GA) which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (<32 weeks GA) recruited by the NICU of 2 specialized hospitals. The participating families will be divided into 3 groups: a reference group (i.e. full term infants and their parents, receiving care as usual), a control group (i.e. premature infants and their parents, receiving care as usual) and an intervention group (i.e. premature infants and their parents, receiving VIG). The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic) stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying, eating, and sleeping.
Discussion
This is the first prospective study to empirically evaluate the effect of VIG in parents of premature infants. Family recruitment is expected to be completed in January 2012. First results should be available by 2012.
Trail registration number
NTR3423
doi:10.1186/1471-2431-12-76
PMCID: PMC3464160  PMID: 22709245
20.  Preterm birth 
Clinical Evidence  2011;2011:1404.
Introduction
Preterm birth occurs in about 5% to 10% of all births in resource-rich countries, but in recent years the incidence seems to have increased in some countries, particularly in the USA. We found little reliable evidence for incidence in resource-poor countries. The rate in northwestern Ethiopia has been reported to vary from 11% to 22%, depending on the age group of mothers studied, and is highest in teenage mothers.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in women at high risk of preterm delivery? What are the effects of interventions to improve neonatal outcome after preterm rupture of membranes? What are the effects of treatments to stop contractions in preterm labour? What are the effects of elective compared with selective caesarean delivery for women in preterm labour? What are the effects of interventions to improve neonatal outcome in preterm delivery? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 58 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: amnioinfusion for preterm rupture of membranes, antenatal corticosteroids, antibiotic treatment, bed rest, beta-mimetics, calcium channel blockers, elective caesarean, enhanced antenatal care programmes, magnesium sulphate, oxytocin receptor antagonists (atosiban), progesterone, prophylactic cervical cerclage, prostaglandin inhibitors (e.g., indometacin), selective caesarean, and thyrotropin-releasing hormone (TRH) (plus corticosteroids).
Key Points
Around 5% to 10% of all births in resource-rich countries occur before 37 weeks' gestation, leading to increased risks of neonatal and infant death, and of neurological disability in surviving infants.
Progesterone may reduce preterm birth in women with prior preterm birth and a short cervix, but are unlikely to be beneficial and may even be harmful in women with multiple gestations.
Enhanced antenatal care programmes and bed rest have repeatedly been shown to be ineffective or harmful. Prophylactic cervical cerclage may reduce preterm births in women with cervical changes but is unlikely to be effective — and may increase infection — in women with no cervical changes or with twin pregnancies. We don't know how effective it is in women with protruding membranes.
A single course of antenatal corticosteroids reduces respiratory distress syndrome, intraventricular haemorrhage, and neonatal mortality compared with placebo in babies born before 37 weeks' gestation. Adding TRH to corticosteroids has not been shown to improve outcomes compared with corticosteroids alone, and increases the risk of adverse effects.
Antibiotics may prolong the pregnancy and reduce infection after premature rupture of the membranes, but are not beneficial when the membranes are intact.
It is unclear if amnioinfusion for preterm rupture of membranes reduces preterm birth or neonatal mortality, as we found few RCTs.
Calcium channel blockers may be effective at delaying labour compared with other tocolytics. Beta-mimetics and magnesium sulphate do not prevent premature birth, and may increase fetal and maternal adverse effects compared with placebo. Oxytocin receptor antagonists (such as atosiban) and prostaglandin inhibitors (such as indometacin) may prevent preterm delivery but we cannot be certain as we found few trials.Most tocolytic therapies don't prevent perinatal mortality or morbidity, although trials of these treatments are usually underpowered to detect clinically significant differences in these outcomes.
Elective caesarean section increases maternal morbidity compared with selective caesarean section, but rates of neonatal morbidity and mortality seem equivalent.
PMCID: PMC3217816  PMID: 21463540
21.  Maintaining Optimal Oxygen Saturation in Premature Infants 
The Permanente Journal  2011;15(1):e108-e113.
Introduction: Advances in technology have resulted in increasing survival rates for premature infants. Oxygen therapy is commonly used in neonatal units as part of respiratory support. The number of premature infants in our institution surviving with severe (stage ≥3) retinopathy of prematurity (ROP) prompted a review of oxygen therapy as a contributing factor. Prolonged exposure to high concentrations of oxygen may cause irreversible damage to the eyes of very-low-birth-weight preterm infants and is a potential cause of blindness.
Objective: We developed strategies to reduce incidence of severe ROP requiring laser surgery in premature infants.
Methods: We studied 37 preterm infants who were born at a gestational age of <32 weeks, with a birth weight of <1500 g, receiving supplemental oxygen, and had been admitted to our neonatal intensive care unit. Infants received oxygen via mechanical ventilator, nasal continuous positive airway pressure (CPAP), or intranasal (I/N) and titration of oxygen was based on each infant's measured oxygen saturation (Spo2). For each infant, we monitored the Spo2 trend, Spo2 alarm limit, and the percentage of time that the alarm limit was set incorrectly. We implemented a Spo2 targeting protocol and developed an algorithm for titrating fraction of inspired oxygen (Fio2).
Results: After phase 1 of implementation, the percentage of time that Spo2 readings were >95% was reduced to between 20% and 50%. However, our findings raised concern regarding the wide fluctuation of Spo2 readings because of inconsistency in Fio2 titration, which can contribute to deviation from the optimal target range. Accordingly, we developed an algorithm for titrating Fio2 aimed at maintaining each infant's Spo2 within the optimal target range. After phase 2 of implementation, the percentage of Spo2 readings >95% was markedly reduced to between 0% and 15%. The incidence of infants with severe ROP requiring laser surgery decreased from 5 to 1.
Conclusions: A change in clinical practice aimed at maintaining oxygen within the target range to avoid a high Spo2 was associated with a significant decrease in the incidence of both severe ROP and the need for laser surgery, thus reducing hospital costs and length of hospital stays for premature infants.
PMCID: PMC3138176  PMID: 21892344
22.  A comparison of Wisconsin Neonatal Intensive Care Units with National data on outcomes and practices 
Context:
Improvements in neonatal care over the past three decades have resulted in increased survival of infants at lower birthweights and gestational ages. However, outcomes and practices vary considerably between hospitals.
Objective:
To describe maternal and infant characteristics, NICU practices, morbidity, and mortality in Wisconsin neonatal intensive care units (NICU) and to compare outcomes in Wisconsin to the National Institute of Child Health and Human Development network of large academic medical center NICUs.
Design and Setting:
The Newborn Lung Project Statewide Cohort is a prospective observational study of all very low birthweight (≤ 1500 grams) infants admitted during 2003 and 2004 to the 16 level III NICUs in Wisconsin. Anonymous data were collected for all admitted infants (N=1463).
Main outcome measures:
Major neonatal morbidities, including bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity were evaluated.
Results:
The overall incidence of bronchopulmonary dysplasia was 24% (range 8-56% between NICUs); intraventricular hemorrhage incidence was 23% (9-41%); the incidence of necrotizing enterocolitis was 7% (0-21%); and the incidence of grade III or higher retinopathy of prematurity was 10% (0-35%).
Conclusion:
The incidence rates of major neonatal morbidities in Wisconsin were similar to those of a national network of academic NICUs.
PMCID: PMC2650395  PMID: 19180870
23.  Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol 
Reproductive Health  2012;9:22.
Background
Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births.
Methods
We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants.
Trial registration
ClinicalTrials.gov. Identifier: NCT01084096
doi:10.1186/1742-4755-9-22
PMCID: PMC3477119  PMID: 22992312
Neonatal mortality; Antenatal corticosteroids; Implementation research; Preterm birth
24.  Short term outcomes after extreme preterm birth in England: comparison of two birth cohorts in 1995 and 2006 (the EPICure studies) 
Objective To determine survival and neonatal morbidity for babies born between 22 and 26 weeks’ gestation in England during 2006, and to evaluate changes in outcome since 1995 for babies born between 22 and 25 weeks’ gestation.
Design Prospective national cohort studies.
Setting Maternity and neonatal units in England.
Participants 3133 births between 22 and 26 weeks’ gestation in 2006; 666 admissions to neonatal units in 1995 and 1115 in 2006 of babies born between 22 and 25 weeks’ gestation.
Main outcome measures Survival to discharge from hospital, pregnancy and delivery outcomes, infant morbidity until discharge.
Results In 2006, survival of live born babies was 2% (n=3) for those born at 22 weeks’ gestation, 19% (n=66) at 23 weeks, 40% (n=178) at 24 weeks, 66% (n=346) at 25 weeks, and 77% (n=448) at 26 weeks (P<0.001). At discharge from hospital, 68% (n=705) of survivors had bronchopulmonary dysplasia (receiving supplemental oxygen at 36 weeks postmenstrual age), 13% (n=135) had evidence of serious abnormality on cerebral ultrasonography, and 16% (n=166) had laser treatment for retinopathy of prematurity. For babies born between 22 and 25 weeks’ gestation from March to December, the number of admissions for neonatal care increased by 44%, from 666 in 1995 to 959 in 2006. By 2006 adherence to evidence based practice associated with improved outcome had significantly increased. Survival increased from 40% to 53% (P<0.001) overall and at each week of gestation: by 9.5% (confidence interval −0.1% to 19%) at 23 weeks, 12% (4% to 20%) at 24 weeks, and 16% (9% to 23%) at 25 weeks. The proportions of babies surviving in 2006 with bronchopulmonary dysplasia, major cerebral scan abnormality, or weight and/or head circumference <−2 SD were similar to those in 1995, but the proportion treated for retinopathy of prematurity had increased from 13% to 22% (P=0.006). Predictors of mortality and morbidity were similar in both cohorts.
Conclusion Survival of babies born between 22 and 25 weeks’ gestation has increased since 1995 but the pattern of major neonatal morbidity and the proportion of survivors affected are unchanged. These observations reflect an important increase in the number of preterm survivors at risk of later health problems.
doi:10.1136/bmj.e7976
PMCID: PMC3514472  PMID: 23212881
25.  Birth weight and gestational age on retinopathy of prematurity in discordant twins in China 
AIM
To assess the relative effect of birth weight and gestational age on retinopathy of prematurity (ROP) using preterm twin pairs discordant for birth weigh in a tertiary neonatal intensive care unit in China.
METHODS
Fifty-six discordant twin pairs of 112 preterm infants were retrospectively analyzed. The twin pairs were divided into two subgroups based on birth weight in each pair. The occurrence of ROP and severe ROP requiring treatment were compared between the lower birth weight infants and their co-twins with the higher birth weight. Some neonatal morbidities related to prematurity and neonatal characteristics were also compared between the twin pairs.
RESULTS
Based on the univariate analysis, gestational age and birth weight were significantly associated with the occurrence and progression of ROP. But no significant differences in ROP between larger and smaller infants were observed in the twin-paired analysis. The incidence of neonatal morbidities regarding respiratory distress syndrome (RDS), patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), sepsis and neonatal characteristics regarding gender distribution, one- and five-minute Apgar score, postnatal steroid treatment, blood transfusion, supplemental oxygen therapy, and mechanical ventilation were not different between the twins. However, gestational age of ≤28wk was significantly associated with significantly higher rates of ROP and severe ROP.
CONCLUSION
Gestational age is a better predictor of ROP than birth weight in the twin-paired study.
doi:10.3980/j.issn.2222-3959.2014.04.14
PMCID: PMC4137203  PMID: 25161939
retinopathy of prematurity; gestational age; birth weight

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