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1.  Randomised controlled trial of behavioural infant sleep intervention to improve infant sleep and maternal mood 
BMJ : British Medical Journal  2002;324(7345):1062.
Objective
To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.
Design
Randomised controlled trial.
Setting
Well child clinics, Melbourne, Australia
Participants
156 mothers of infants aged 6-12 months with severe sleep problems according to the parents.
Main outcome measures
Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months.
Intervention
Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.
Results
At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar.
Conclusions
Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores.
What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant sleep problems improves postnatal depression, but there is no good quality evidence in the community for such effectivenessWhat this study addsA brief community based sleep intervention based on teaching the controlled crying method effectively decreased infant sleep problems and symptoms of maternal depression, particularly for “depressed” mothersThe intervention was acceptable to mothers and reduced the need for other sources of help
PMCID: PMC104332  PMID: 11991909
2.  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
3.  Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 
BMC Pediatrics  2012;12:135.
Background
Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.
Methods/Design
Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.
Discussion
An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention’s simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.
Trial Registration
Current Controlled Trials ISRCTN95287767
doi:10.1186/1471-2431-12-135
PMCID: PMC3508922  PMID: 22928654
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota
4.  Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial 
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design Double blind, placebo controlled randomised trial.
Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions Oral daily L reuteri (1×108 colony forming units) versus placebo for one month.
Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial registration Current Controlled Trials ISRCTN95287767.
doi:10.1136/bmj.g2107
PMCID: PMC3972414  PMID: 24690625
5.  Admission to day stay early parenting program is associated with improvements in mental health and infant behaviour: A prospective cohort study 
Background
Australia’s Early Parenting Services support families and intervene early in mental health problems in parents. The Victorian Early Parenting Strategy, a platform for government policy recommended a stronger evidence base for early parenting services. Tweddle Child and Family Health Service (TCFHS) is a not-for-profit public sector early parenting centre, which provides residential, day stay, home visiting and outreach programs. This study aimed i) to examine the health, social circumstances and presenting needs of clients attending the Tweddle Day Stay Program (DSP) with infants under 12 months old and ii) to assess the parent mental health and infant behaviour outcomes and the factors associated with program success.
Methods
A cohort of clients was recruited prior to admission and followed-up 8 weeks after discharge. Data were collected using standardised measures in a study specific questionnaire at baseline, participant’s Tweddle records and a follow-up telephone interview. Health, social circumstances and presenting needs of clients were described. Changes in parents’ symptoms of depression and infants’ sleep and settling between admission and follow-up were calculated. Multiple regression analyses were conducted to examine factors associated with changes in primary outcomes.
Results
Of the total 162 clients who were eligible and invited to participate, 115 (72%) were recruited. Parents admitted to the DSP had worse general self-reported physical and mental health than community samples. Infants of DSP participants were no more likely to be premature or have low birth weight, but significantly more unsettled than other community samples. Participants’ mental health and their infants’ behaviours were significantly improved after DSP admission. In multivariate analysis, higher depression score at baseline and greater educational attainment were significantly associated with improvements in parents’ mental health. Worse unsettled infant behaviours and longer time between discharge and follow up were significantly associated with improvements in infant sleep and settling.
Conclusions
Tweddle DSPs appear to respond effectively to the needs of families presenting with substantial physical and emotional health morbidity and a range of vulnerabilities by treating parental mental health and infant behaviour problems together. DSPs offer important potential benefits for prevention of more serious family problems and consequent health care cost savings.
doi:10.1186/1752-4458-6-11
PMCID: PMC3464700  PMID: 22889314
Parenting; Infants; Mental health; Health services
6.  Distinguishing infant prolonged crying from sleep-waking problems 
Archives of disease in childhood  2011;96(4):340-344.
Objective
Infants who cry a lot, or are unsettled in the night, are common sources of concern for parents and costly problems for health services. The two types of problems have been linked together and attributed to a general disturbance of infant regulation. Yet the infant behaviours involved present differently, at separate ages and times of day. To clarify causation, this study aims to assess whether prolonged crying at 5–6 weeks (the peak age for crying) predicts which infants are unsettled in the night at 12 weeks of age (when most infants become settled at night).
Methods
Data from two longitudinal studies are analysed. Infant crying data were obtained from validated behaviour diaries; sleep-waking data from standard parental questionnaires.
Results
A significant, weak relationship was found between crying at 5–6 weeks and 12-week night waking and signalling in one study, but not the other. Most infants who met the definition for prolonged crying/colic at 5–6 weeks were settled during the night at 12 weeks of age; they were not more likely than other infants to be unsettled.
Conclusions
Most infants who cry a lot at 5–6 weeks of age ‘sleep through the night’ at 12 weeks of age. This adds to evidence that the two types of problematic behaviour have different causes, and that infant sleep-waking problems usually involve maintenance of signalling behaviours rather than a generalised disturbance.
doi:10.1136/adc.2010.200204
PMCID: PMC3202670  PMID: 21220260
7.  Economic evaluation of strategies for managing crying and sleeping problems 
AIMS—To estimate the financial cost to the NHS of infant crying and sleeping problems in the first 12 weeks of age and to assess the cost effectiveness of behavioural and educational interventions aimed at reducing infant crying and sleeping problems relative to usual services.
METHODS—A cost burden analysis and cost effectiveness analysis were conducted using data from the Crying Or Sleeping Infants (COSI) Study, a three armed prospective randomised controlled trial that randomly allocated 610 mothers to a behavioural intervention (n = 205), an educational intervention (n = 202), or existing services (control, n = 203). Main outcome measures were annual total cost to the NHS of infant crying and sleeping problems in the first 12 weeks, and incremental cost per interruption free night gained for behavioural and educational interventions relative to control.
RESULTS—The annual total cost to the NHS of infant crying and sleeping problems in the first 12 weeks was £65 million (US$104 million). Incremental costs per interruption free night gained for the behavioural intervention relative to control were £0.56 (US$0.92). For the educational intervention relative to control they were £4.13 (US$6.80).
CONCLUSIONS—The annual total cost to the NHS of infant crying and sleeping problems is substantial. In the cost effectiveness analysis, the behavioural intervention incurred a small additional cost and produced a small significant benefit at 11 and 12 weeks of age. The educational intervention incurred a small additional cost without producing a significant benefit.


doi:10.1136/adc.84.1.15
PMCID: PMC1718606  PMID: 11124777
8.  Improving infant sleep and maternal mental health: a cluster randomised trial 
Archives of Disease in Childhood  2006;92(11):952-958.
Objectives
To determine whether a community‐delivered intervention targeting infant sleep problems improves infant sleep and maternal well‐being and to report the costs of this approach to the healthcare system.
Design
Cluster randomised trial.
Setting
49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.
Participants
328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.
Intervention
Behavioural strategies delivered over individual structured MCH consultations versus usual care.
Main outcome measures
Maternal report of infant sleep problem, depression symptoms (Edinburgh Postnatal Depression Scale (EPDS)), and SF‐12 mental and physical health scores when infants were 10 and 12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.
Results
Prevalence of infant sleep problems was lower in the intervention than control group at 10 months (56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50 (0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference −1.4 (−2.3 to −0.4) and 12 months (−1.7 (−2.6 to −0.7)). SF‐12 mental health scores indicated better health at 10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs including intervention design, delivery and use of non‐MCH nurse services were £96.93 and £116.79 per intervention and control family, respectively.
Conclusions
Implementing this sleep intervention may lead to health gains for infants and mothers and resource savings for the healthcare system.
Trial registration
Current Controlled Trial Registry, number ISRCTN48752250 (registered November 2004).
doi:10.1136/adc.2006.099812
PMCID: PMC2083609  PMID: 17158146
9.  Effect of behavioural-educational intervention on sleep for primiparous women and their infants in early postpartum: multisite randomised controlled trial 
Objective To evaluate the effectiveness of a behavioural-educational sleep intervention delivered in the early postpartum in improving maternal and infant sleep.
Design Randomised controlled trial.
Setting Postpartum units of two university affiliated hospitals.
Participants 246 primiparous women and their infants randomised while in hospital with an internet based randomisation service to intervention (n=123) or usual care (n=123) groups.
Interventions The behavioural-educational sleep intervention included a 45-60 minute meeting with a nurse to discuss sleep information and strategies to promote maternal and infant sleep, a 20 page booklet with the content discussed, and phone contacts at one, two, and four weeks postpartum to reinforce information, provide support, and problem solve. The usual care group received calls at weeks one, two, and four to maintain contact without provision of advice.
Main outcome measures Primary outcome was maternal nocturnal (9 pm to 9 am) sleep (minutes) and secondary outcome was longest stretch of infant nocturnal sleep (minutes) measured at six and 12 weeks postpartum by actigraphy. Other outcomes measured at six and 12 weeks were number of maternal and infant night time awakenings by actigraphy, fatigue visual analogue scale, general sleep disturbance scale, and Edinburgh postnatal depression scale. Rates of exclusive breast feeding were measured at 12 weeks postpartum only.
Results All women who completed any outcome measures at six or 12 weeks were included in analysis. Sleep outcomes were completed at one or both of six and 12 weeks postpartum for 215 of 246 (87%) women (110/123 intervention and 105/123 usual care). Longitudinal mixed effects model analyses indicated no significant differences between the groups on any of the outcomes. The estimated mean difference in maternal nocturnal sleep between the intervention and usual care groups was 5.97 minutes (95% confidence interval −7.55 to 19.5 minutes, P=0.39). No differences in any outcomes were noted based on the specific nurse delivering the intervention or the number of phone contacts received.
Conclusion A behavioural-educational intervention delivered in the early postpartum, in hospital, and in the first weeks at home, was ineffective in improving maternal and infant sleep or other health outcomes in the first months postpartum.
Trial registration ISRCT No 13501166.
doi:10.1136/bmj.f1164
PMCID: PMC3603553  PMID: 23516146
10.  Development of a universal psycho-educational intervention to prevent common postpartum mental disorders in primiparous women: a multiple method approach 
BMC Public Health  2010;10:499.
Background
Prevention of postnatal mental disorders in women is an important component of comprehensive health service delivery because of the substantial potential benefits for population health. However, diverse approaches to prevention of postnatal depression have had limited success, possibly because anxiety and adjustment disorders are also problematic, mental health problems are multifactorially determined, and because relationships amongst psychosocial risk factors are complex and difficult to modify. The aim of this paper is to describe the development of a novel psycho-educational intervention to prevent postnatal mental disorders in mothers of firstborn infants.
Methods
Data from a variety of sources were synthesised: a literature review summarised epidemiological evidence about neglected modifiable risk factors; clinical research evidence identified successful psychosocial treatments for postnatal mental health problems; consultations with clinicians, health professionals, policy makers and consumers informed the proposed program and psychological and health promotion theories underpinned the proposed mechanisms of effect. The intervention was pilot-tested with small groups of mothers and fathers and their first newborn infants.
Results
What Were We Thinking! is a psycho-educational intervention, designed for universal implementation, that addresses heightened learning needs of parents of first newborns. It re-conceptualises mental health problems in mothers of infants as reflecting unmet needs for adaptations in the intimate partner relationship after the birth of a baby, and skills to promote settled infant behaviour. It addresses these two risk factors in half-day seminars, facilitated by trained maternal and child health nurses using non-psychiatric language, in groups of up to five couples and their four-week old infants in primary care. It is designed to promote confidence and reduce mental disorders by providing skills in sustainable sleep and settling strategies, and the re-negotiation of the unpaid household workload in non-confrontational ways. Materials include a Facilitators' Handbook, creatively designed worksheets for use in seminars, and a book for couples to take home for reference. A website provides an alternative means of access to the intervention.
Conclusions
What Were We Thinking! is a postnatal mental health intervention which has the potential to contribute to psychologically-informed routine primary postnatal health care and prevent common mental disorders in women.
doi:10.1186/1471-2458-10-499
PMCID: PMC2931475  PMID: 20718991
11.  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
12.  A cluster randomised controlled trial of a brief couple-focused psychoeducational intervention to prevent common postnatal mental disorders among women: study protocol 
BMJ Open  2014;4(9):e006436.
Introduction
Postnatal common mental disorders among women are an important public health problem internationally. Interventions to prevent postnatal depression have had limited success. What Were We Thinking (WWWT) is a structured, gender-informed, psychoeducational group programme for parents and their first infant that addresses two modifiable risks to postnatal mental health. This paper describes the protocol for a cluster randomised controlled trial to test the clinical effectiveness and cost-effectiveness of WWWT when implemented in usual primary care.
Methods and analysis
48 maternal and child health (MCH) centres from six diverse Local Government Areas, in Victoria, Australia are randomly allocated to the intervention group (usual care plus WWWT) or the control group (usual care). The required sample size is 184 women in each group. English-speaking primiparous women receiving postpartum healthcare in participating MCH centres complete two computer-assisted telephone interviews: baseline at 4 weeks and outcome at 6 months postpartum. Women attending intervention MCH centres are invited to attend WWWT in addition to usual care. The primary outcome is meeting Diagnostic and Statistical Manual-IV (DSM-IV) diagnostic criteria for major depressive episode; generalised anxiety disorder; panic disorder with or without agoraphobia, agoraphobia with or without panic, social phobia, adult separation anxiety or adjustment disorder with depressed mood, anxiety or mixed depressed mood and anxiety within the past 30 days at 6 months postpartum. Secondary outcomes are self-rated general and emotional health, infant sleep problems, method of infant feeding, quality of mother–infant relationship and intimate partner relationship, and healthcare costs and outcomes.
Ethics and dissemination
Approval to conduct the study has been granted. A comprehensive dissemination plan has been devised.
Trial registration number
Australian New Zealand Clinical Trials Registry ACTRN12613000506796.
UTN
U1111-1125-8208.
doi:10.1136/bmjopen-2014-006436
PMCID: PMC4173107  PMID: 25248497
MENTAL HEALTH; PRIMARY CARE; PREVENTIVE MEDICINE; PUBLIC HEALTH
13.  Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project 
BMC Pediatrics  2010;10:101.
Background
Up to 70% of children with Attention-Deficit/Hyperactivity Disorder (ADHD) experience sleep problems including difficulties initiating and maintaining sleep. Sleep problems in children with ADHD can result in poorer child functioning, impacting on school attendance, daily functioning and behaviour, as well as parental mental health and work attendance. The Sleeping Sound with ADHD trial aims to investigate the efficacy of a behavioural sleep program in treating sleep problems experienced by children with ADHD. We have demonstrated the feasibility and the acceptability of this treatment program in a pilot study.
Methods/Design
This randomised controlled trial (RCT) is being conducted with 198 children (aged between 5 to 12 years) with ADHD and moderate to severe sleep problems. Children are recruited from public and private paediatric practices across the state of Victoria, Australia. Upon receiving informed written consent, families are randomised to receive either the behavioural sleep intervention or usual care. The intervention consists of two individual, face-to-face consultations and a follow-up phone call with a trained clinician (trainee consultant paediatrician or psychologist), focusing on the assessment and management of child sleep problems. The primary outcome is parent- and teacher-reported ADHD symptoms (ADHD Rating Scale IV). Secondary outcomes are child sleep (actigraphy and parent report), behaviour, daily functioning, school attendance and working memory, as well as parent mental health and work attendance. We are also assessing the impact of children's psychiatric comorbidity (measured using a structured diagnostic interview) on treatment outcome.
Discussion
To our knowledge, this is the first RCT of a behavioural intervention aiming to treat sleep problems in children with ADHD. If effective, this program will provide a feasible non-pharmacological and acceptable intervention improving child sleep and ADHD symptoms in this patient group.
Trial Registration
Current Controlled Trials ISRCTN68819261.
ISRCTN: ISRCTN68819261
doi:10.1186/1471-2431-10-101
PMCID: PMC3022790  PMID: 21192797
14.  Preventing sleeping problems in infants who are at risk of developing them 
Archives of Disease in Childhood  2003;88(2):108-111.
Aims: (1) To identify factors at 1 week of age which put infants at risk of failing to sleep through the night at 12 weeks of age. (2) To assess whether a behavioural programme increases the likelihood that these infants will sleep through the night at 12 weeks of age.
Methods: A community sample of 316 newborn infants was employed to identify the risk factors at 1 week of age which increased the likelihood of failing to sleep through the night at 12 weeks of age. Infants who met these risk criteria and were randomly assigned to a behavioural programme were compared with at risk infants in the control group on measures of sleeping, crying, and feeding at 12 weeks of age.
Results: Infants who had a high number (>11) of feeds in 24 hours at 1 week were 2.7 times (95% CI 1.5 to 4.8) more likely than other control group infants to fail to sleep through the night at 12 weeks of age. At 12 weeks, 82% of these at risk infants assigned to the behavioural programme, compared to 61% in the control group, slept through the night. The findings were similar in breast and bottle feeders.
Conclusions: Preventing infant sleeping problems should be more cost effective than treating them after they have arisen. This study provides evidence that it is possible to identify infants who are at risk of failing to sleep through the night at an early age, and that a simple, three step, preventive behavioural programme increases the number who sleep through the night by 21%.
doi:10.1136/adc.88.2.108
PMCID: PMC1719431  PMID: 12538307
15.  The contribution of Australian residential early parenting centres to comprehensive mental health care for mothers of infants: evidence from a prospective study 
Background
Australia's public access residential early parenting services provide programs to assist parents who self-refer, to care for their infants and young children. Treatment programs target infant feeding and sleeping difficulties and maternal mental health. There is limited systematic evidence of maternal and infant mental health, psychosocial circumstances or presenting problems, or the effectiveness of the programs. The aim of this study was to contribute to the evidence base about residential early parenting services.
Methods
A prospective cohort design was used. A consecutive sample of mothers with infants under one year old recruited during admission to a public access residential early parenting service for a 4 or 5 night stay in Melbourne, Australia was recruited. They completed structured self-report questionnaires, incorporating standardised measures of infant behaviour and maternal mood, during admission and at one and six months after discharge. Changes in infant behaviour and maternal psychological functioning after discharge were observed.
Results
79 women completed the first questionnaire during admission, and 58 provided complete data. Women admitted to the residential program have poor physical and mental health, limited family support, and infants with substantial behaviour difficulties. One month after discharge significant improvements in infant behaviour and maternal psychological functioning were observed (mean (SD) daily crying and fussing during admission = 101.02 (100.8) minutes reduced to 37.7 (55.2) at one month post discharge, p < 0.001; mean (SD) Edinburgh Postnatal Depression Scale at admission = 11.3 (5.7) reduced to 6.78 (4.44), at one month, p < 0.001) which were sustained at six months. Participant satisfaction with the program was high; 58 (88%) found the support of the nurses and 50 (75%) the social support of other mothers very helpful.
Conclusions
This psycho-educational approach is an effective and acceptable early intervention for parenting difficulties and maternal mood disturbance, and contributes to a system of comprehensive mental health care for mothers of infants.
doi:10.1186/1752-4458-4-6
PMCID: PMC2873569  PMID: 20380739
16.  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
17.  Sleep and breathing in premature infants at 6 months post-natal age 
BMC Pediatrics  2014;14(1):303.
Background
Poor sleep contributes to the developmental problems seen in preterm infants. We evaluated sleep problems in preterm infants 6 months of post-gestational age using the subjective Brief Infant Sleep Questionnaire (BISQ) and objective sleep tests. We also compared the sleep of premature infants with that of full-term infants.
Methods
The study included 68 6-month-old full-term healthy infants and 191 premature infants born at <37 weeks gestation. All parents completed the BISQ-Chinese version and sleep diaries. At the same time, all premature infants were submitted to one night of polysomnography (PSG) in the sleep laboratory and also were set up with an actigraph kept for 7 days. Statistical analyses were performed using correlation coefficients and the t-test with SPSS version 18 to compare questionnaire responses with other subjective and objective measures of sleep.
Results
The sleep problems indicated in the subjective questionnaire for the premature infants, particularly: “the nocturnal sleep duration, number of night awakenings, daytime sleep duration, duration of time with mouth breathing, and loud-noisy breathing” had significant correlations with sleep diaries, actigraphy and PSG results. The BISQ showed that duration of infant’s sleeping on one side, nocturnal sleep duration, being held to fall asleep, number of nighttime awakenings, daytime sleep duration, subjective consideration of sleep problems, loud-noisy breathing, and duration spent crying during the night were significantly different between the premature infants and the term infants. PSG confirmed the presence of a very high percentage (80.6%) of premature infants with AHI > 1 event/hour as indicated by the questionnaire.
Conclusion
Premature infants have more sleep problems than full-term infants, including the known risk of abnormal breathing during sleep, which has been well demonstrated already with the BISQ-Chinese (CBISQ).
Electronic supplementary material
The online version of this article (doi:10.1186/s12887-014-0303-6) contains supplementary material, which is available to authorized users.
doi:10.1186/s12887-014-0303-6
PMCID: PMC4272529  PMID: 25510740
Sleep questionnaire; Sleep-disordered breathing; Prematurity; Full-term infant
18.  An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness 
Trials  2013;14:210.
Background
Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant’s physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents.
An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent–infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby’s development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems.
Methods/design
The study comprises a multicentre randomised controlled trial using a mixed-methods approach to data collection and analysis in order to identify which families are most able to benefit from this intervention.
The study is being conducted in six family centres across the UK, and targets primary caregivers of children less than 2.5 years of age who are substance dependent. Consenting participants are randomly allocated to either the 20-week PuP programme or to standard care.
The primary outcome is child abuse potential, and secondary outcomes include substance use, parental mental health and emotional regulation, parenting stress, and infant/toddler socio-emotional adjustment scale.
Discussion
This is one the first UK studies to examine the effectiveness of a programme targeting the parenting of substance-dependent parents of infants and toddlers, in terms of its effectiveness in improving the parent–infant relationship and reducing the potential for child abuse.
Trial registration
International Standard Randomised Controlled Trial Number Register: ISRCTN47282925
doi:10.1186/1745-6215-14-210
PMCID: PMC3717037  PMID: 23841920
Parenting; Substance misuse; Drug abuse; Alcohol abuse; Infants; Parents under pressure
19.  Pregnancy and Infant Outcomes among HIV-Infected Women Taking Long-Term ART with and without Tenofovir in the DART Trial 
PLoS Medicine  2012;9(5):e1001217.
Diana Gibb and colleagues investigate the effect of in utero tenofovir exposure by analyzing the pregnancy and infant outcomes of HIV-infected women enrolled in the DART trial.
Background
Few data have described long-term outcomes for infants born to HIV-infected African women taking antiretroviral therapy (ART) in pregnancy. This is particularly true for World Health Organization (WHO)–recommended tenofovir-containing first-line regimens, which are increasingly used and known to cause renal and bone toxicities; concerns have been raised about potential toxicity in babies due to in utero tenofovir exposure.
Methods and Findings
Pregnancy outcome and maternal/infant ART were collected in Ugandan/Zimbabwean HIV-infected women initiating ART during The Development of AntiRetroviral Therapy in Africa (DART) trial, which compared routine laboratory monitoring (CD4; toxicity) versus clinically driven monitoring. Women were followed 15 January 2003 to 28 September 2009. Infant feeding, clinical status, and biochemistry/haematology results were collected in a separate infant study. Effect of in utero ART exposure on infant growth was analysed using random effects models.
382 pregnancies occurred in 302/1,867 (16%) women (4.4/100 woman-years [95% CI 4.0–4.9]). 226/390 (58%) outcomes were live-births, 27 (7%) stillbirths (≥22 wk), and 137 (35%) terminations/miscarriages (<22 wk). Of 226 live-births, seven (3%) infants died <2 wk from perinatal causes and there were seven (3%) congenital abnormalities, with no effect of in utero tenofovir exposure (p>0.4). Of 219 surviving infants, 182 (83%) enrolled in the follow-up study; median (interquartile range [IQR]) age at last visit was 25 (12–38) months. From mothers' ART, 62/9/111 infants had no/20%–89%/≥90% in utero tenofovir exposure; most were also zidovudine/lamivudine exposed. All 172 infants tested were HIV-negative (ten untested). Only 73/182(40%) infants were breast-fed for median 94 (IQR 75–212) days. Overall, 14 infants died at median (IQR) age 9 (3–23) months, giving 5% 12-month mortality; six of 14 were HIV-uninfected; eight untested infants died of respiratory infection (three), sepsis (two), burns (one), measles (one), unknown (one). During follow-up, no bone fractures were reported to have occurred; 12/368 creatinines and seven out of 305 phosphates were grade one (16) or two (three) in 14 children with no effect of in utero tenofovir (p>0.1). There was no evidence that in utero tenofovir affected growth after 2 years (p = 0.38). Attained height- and weight for age were similar to general (HIV-uninfected) Ugandan populations. Study limitations included relatively small size and lack of randomisation to maternal ART regimens.
Conclusions
Overall 1-year 5% infant mortality was similar to the 2%–4% post-neonatal mortality observed in this region. No increase in congenital, renal, or growth abnormalities was observed with in utero tenofovir exposure. Although some infants died untested, absence of recorded HIV infection with combination ART in pregnancy is encouraging. Detailed safety of tenofovir for pre-exposure prophylaxis will need confirmation from longer term follow-up of larger numbers of exposed children.
Trial registration
www.controlled-trials.com ISRCTN13968779
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Currently, about 34 million people (mostly in low- and middle-income countries) are infected with HIV, the virus that causes AIDS. At the beginning of the epidemic, more men than women were infected with HIV but now about half of all people living with HIV/AIDS are women, most of who became infected through unprotected sex with an infected partner. In sub-Saharan Africa alone, 12 million women are HIV-positive. Worldwide, HIV/AIDS is the leading cause of death among women of child-bearing age. Moreover, most of the 400,000 children who become infected with HIV every year acquire the virus from their mother during pregnancy or birth, or through breastfeeding, so-called mother-to-child transmission (MTCT). Combination antiretroviral therapy (ART)—treatment with cocktails of powerful antiretroviral drugs—reduces HIV-related illness and death among women, and ART given to HIV-positive mothers during pregnancy and delivery and to their newborn babies greatly reduces MTCT.
Why Was This Study Done?
Because of ongoing international efforts to increase ART coverage, more HIV-positive women in Africa have access to ART now than ever before. However, little is known about pregnancy outcomes among HIV-infected African women taking ART throughout pregnancy for their own health or about the long-term outcomes of their offspring. In particular, few studies have examined the effect of taking tenofovir (an antiretroviral drug that is now recommended as part of first-line ART) throughout pregnancy. Tenofovir readily crosses from mother to child during pregnancy and, in animal experiments, high doses of tenofovir given during pregnancy caused bone demineralization (which weakens bones), kidney problems, and impaired growth among offspring. In this study, the researchers analyze data collected on pregnancy and infant outcomes among Ugandan and Zimbabwean HIV-positive women who took ART throughout pregnancy in the Development of AntiRetroviral Therapy in Africa (DART) trial. This trial was designed to test whether ART could be safely and effectively delivered in Africa without access to the expensive laboratory tests that are routinely used to monitor ART toxicity and efficacy in developed countries.
What Did the Researchers Do and Find?
The pregnancy outcomes of 302 women who became pregnant during the DART trial and information on birth defects among their babies were collected as part of the DART protocol; information on the survival, growth, and development of the infants born to these women was collected in a separate infant study. Most of the women who became pregnant were taking tenofovir-containing ART before and throughout their pregnancies. 58% of the pregnancies resulted in a live birth, 7% resulted in a stillbirth (birth of a dead baby at any time from 22 weeks gestation to the end of pregnancy), and 35% resulted in a termination or miscarriage (before 22 weeks gestation). Of the 226 live births, seven infants died within 2 weeks and seven had birth defects. Similar proportions of the infants exposed and not exposed to tenofovir during pregnancy died soon after birth or had birth defects. Of the 182 surviving infants who were enrolled in the infant study, 14 subsequently died at an average age of 9 months, giving a 1-year mortality of 5%. None of the surviving children who were tested (172 infants) were HIV infected. No bone fractures or major kidney problems occurred during follow-up and prebirth exposure to tenofovir in utero had no effect on growth or weight gain at 2 years (in contrast to a previous US study).
What Do These Findings Mean?
By showing that prebirth tenofovir exposure does not affect pregnancy outcomes or increase birth defects, growth abnormalities, or kidney problems, these findings support the use of tenofovir-containing ART during pregnancy among HIV-positive African women, and suggest that it could also be used to prevent women of child-bearing age acquiring HIV-infection heterosexually. Notably, the observed 5% 1-year infant mortality is similar to the 2%–4% infant mortality normally seen in the region. The absence of HIV infection among the infants born to the DART participants is also encouraging. However, this is a small study (only 111 infants were exposed to tenofovir throughout pregnancy) and women were not randomly assigned to receive tenofovir-containing ART. Consequently, more studies are needed to confirm that tenofovir exposure during pregnancy does not affect pregnancy outcomes or have any long-term effects on infants. Such studies are essential because the use of tenofovir as a treatment for women who are HIV-positive is likely to increase and tenofovir may also be used in the future to prevent HIV acquisition in HIV-uninfected women.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001217.
Information is available from the US National Institute of Allergy and infectious diseases on all aspects of HIV infection and AIDS
NAM/aidsmap provides basic information about HIV/AIDS, and summaries of recent research findings on HIV care and treatment (in several languages)
Information is available from Avert, an international AIDS nonprofit on many aspects of HIV/AIDS, including detailed information on HIV/AIDS treatment and care, women, HIV and AIDS, children, HIV and AIDS, and on HIV/AIDS and pregnancy (some information in English and Spanish); personal stories of women living with HIV are available
More information about the DART trial is available
Additional patient stories about living with HIV/AIDS are available through the nonprofit website Healthtalkonline
doi:10.1371/journal.pmed.1001217
PMCID: PMC3352861  PMID: 22615543
20.  GORD in children 
Clinical Evidence  2008;2008:0310.
Introduction
Gastro-oesophageal regurgitation is considered a problem if it is frequent, persistent, and associated with other symptoms such as increased crying, discomfort with regurgitation, and frequent back arching. A cross-sectional survey of parents of 948 infants attending 19 primary care paediatric practices found that regurgitation of at least one episode a day was reported in 51% of infants aged 0 to 3 months.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatment for symptomatic gastro-oesophageal reflux? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (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 27 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: domperidone, feed thickeners in infants, H2 antagonists, head elevated sleep positioning, left lateral or prone sleep positioning, metoclopramide, proton pump inhibitors, sodium alginate, surgery, soy formula with added fibre, and weight loss.
Key Points
Reflux of gastric contents into the oesophagus in children causes recurrent vomiting (usually before 6 weeks of age), epigastric and abdominal pain, feeding difficulties, failure to thrive, and irritability. At least half of infants regurgitate feeds at least once a day, but this only causes other problems in about 20% of infants, and most cases resolve spontaneously by 12 to 18 months of age.Risk factors include lower oesophageal sphincter disorders, hiatus hernia, gastric distension, raised intra-abdominal pressure, and neurodevelopmental problems.
Sleeping in the left lateral or prone position may improve oesophageal pH compared with sleeping supine or on the right side, but these positions may increase the risk of SIDS compared with supine sleeping, and their effect on clinically important outcomes is unknown. We don't know whether sleeping in the prone elevated position reduces symptoms compared with the prone horizontal position, or whether weight loss reduces symptoms.
Thickened feeds may reduce the severity and frequency of regurgitation in the short term.
Sodium alginate may reduce the frequency of regurgitation compared with placebo, although studies have given conflicting results. The high sodium content of sodium alginate may make it unsuitable for use in preterm babies.
Metoclopramide may be effective, but studies have given conflicting results and it can cause adverse effects.
We don't know whether domperidone, H2 antagonists, proton pump inhibitors, or surgery reduce symptoms in babies with gastro-oesophageal reflux, and they may cause adverse effects.
Soy-based formula with added fibre may reduce the frequency of regurgitation in infants in the neonatal period compared with cow’s milk infant formulas.
PMCID: PMC2907988  PMID: 19445794
21.  Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial 
PLoS Medicine  2012;9(3):e1001192.
A study conducted in Australia provides new data on the outcomes for mother and baby associated with either planned vaginal birth, or elective repeat caesarean section following a previous caesarean section.
Background
Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC.
Methods and findings
2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled.
The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19–0.80; number needed to treat to benefit 66; 95% CI 40–200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17–0.80).
Conclusions
Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean.
Trial registration
Current Controlled Trials ISRCTN53974531
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Rates of caesarean section are rising around the world, particularly in high- and middle-income countries, where most women have a choice of how their baby is delivered. Historically, the obstetrician in charge of the woman's care made the decision on whether to perform an elective (planned) caesarean section based on medical criteria. For women who have had a previous caesarean section, typically, their options for mode of childbirth are either a trial of vaginal birth or an elective repeat caesarean section. The proportion of women attempting a vaginal birth after a previous caesarean section has been declining in many countries partly due to the variable chance of achieving a successful vaginal birth (reported between 56% and 80%) and partly because of negative reports of the risk of complications, both to the mother and the baby, of a having a vaginal delivery following a caesarean section. Consequently, the rates of repeat caesarean section have risen sharply, for example, currently 83% in Australia and almost 90% in the US.
Why Was This Study Done?
Both elective repeat caesarean section and subsequent vaginal delivery after a previous caesarean section have clinical risks and benefits. Most obviously, having a surgical procedure puts the woman having the repeat caesarean section at risk of surgical complications, especially if performed under a general anesthetic, and her baby may be at risk of respiratory complications. However, subsequent vaginal delivery following a previous caesarean section may put the mother at risk of bleeding severely enough to need a blood transfusion (more than 1,500 ml blood loss) and she may also be at increased risk of rupturing her uterus; and her baby may have an increased risk of dying or of becoming brain damaged due to lack of oxygen.
However, to date there have been no randomized controlled trials of elective repeat caesarean section versus vaginal delivery following a previous caesarean section to compare the health outcomes of mother and baby and a recent systematic review could draw no conclusions. So the researchers conducted this prospective cohort study based on patient preference (with a few women agreeing to be randomized to mode of delivery), to compare the health outcomes for mother and baby for elective repeat caesarean section versus vaginal delivery in women following a previous caesarean section.
What Did the Researchers Do and Find?
Between 2002 and 2007, the researchers recruited 2,345 suitable women (that is, women who had one previous caesarean section, were currently 37 weeks pregnant with a single baby, and who were clinically able to have a vaginal delivery) from 14 maternity hospitals throughout Australia. A few women (22) agreed to be randomized to either mode of delivery but most women chose her preferred option. Then, depending on the woman's preferences for mode of birth, participating obstetricians either scheduled a date for an elective caesarean section (1,098 women) or assessed on-going suitability for the woman to have a planned vaginal delivery (1,225 women). However only 535 (43.2%) women who chose to have a vaginal birth were able to deliver this way because of failure to progress in labor or fetal distress: 334 of these women (27.0%) had to have an elective caesarean section and 368 women had to have an emergency caesarean section.
Although no women died, women who had a planned caesarean section experienced less severe bleeding than women who delivered vaginally. There were no infant deaths in those born by elective caesarean section but two unexplained stillbirths in the planned vaginal delivery group. There was also a reduced risk of nonfatal serious outcome before discharge from hospital for infants delivered by in the elective caesarean section. The researchers calculated that one infant death or near death would be prevented for every 66 elective caesarean sections performed in women who had a previous caesarean section.
What Do These Findings Mean?
These findings show that in women who had delivered by a previous caesarean section delivering their next baby by planned caesarean section was associated with less infant death and better health outcomes for the mother before she was discharged from the hospital compared to women who had a subsequent vaginal delivery. This information can be used by women, clinicians, and policy makers in helping to make decisions about the mode of subsequent deliveries and best care for women who have had a previous caesarean section.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001192.
This study is linked to a PLoS Medicine Research Article by Fitzpatrick and colleagues and a PLoS Medicine Perspective by Catherine Spong
The American Congress of Obstetricians and Gynecologists has information sheets for patients on caesarean sections and on vaginal birth after caesarean delivery
Childbirth Connection, a US-based not-for-profit organization, provides information about caesarean sections and about vaginal birth after caesarean
The National Childbirth Trust, a UK charity, provides information for parents on all aspects of pregnancy and birth, including caesarean sections and vaginal birth after caesarean delivery
The UK charity Healthtalkonline has personal stories from women making decisions about birth after a caesarean section
doi:10.1371/journal.pmed.1001192
PMCID: PMC3302845  PMID: 22427749
22.  Sleep-Disordered Breathing and Mortality: A Prospective Cohort Study 
PLoS Medicine  2009;6(8):e1000132.
In a cohort of 6,441 volunteers followed over an average of 8.2 years, Naresh Punjabi and colleagues find sleep-disordered breathing to be independently associated with mortality and identify predictive characteristics.
Background
Sleep-disordered breathing is a common condition associated with adverse health outcomes including hypertension and cardiovascular disease. The overall objective of this study was to determine whether sleep-disordered breathing and its sequelae of intermittent hypoxemia and recurrent arousals are associated with mortality in a community sample of adults aged 40 years or older.
Methods and Findings
We prospectively examined whether sleep-disordered breathing was associated with an increased risk of death from any cause in 6,441 men and women participating in the Sleep Heart Health Study. Sleep-disordered breathing was assessed with the apnea–hypopnea index (AHI) based on an in-home polysomnogram. Survival analysis and proportional hazards regression models were used to calculate hazard ratios for mortality after adjusting for age, sex, race, smoking status, body mass index, and prevalent medical conditions. The average follow-up period for the cohort was 8.2 y during which 1,047 participants (587 men and 460 women) died. Compared to those without sleep-disordered breathing (AHI: <5 events/h), the fully adjusted hazard ratios for all-cause mortality in those with mild (AHI: 5.0–14.9 events/h), moderate (AHI: 15.0–29.9 events/h), and severe (AHI: ≥30.0 events/h) sleep-disordered breathing were 0.93 (95% CI: 0.80–1.08), 1.17 (95% CI: 0.97–1.42), and 1.46 (95% CI: 1.14–1.86), respectively. Stratified analyses by sex and age showed that the increased risk of death associated with severe sleep-disordered breathing was statistically significant in men aged 40–70 y (hazard ratio: 2.09; 95% CI: 1.31–3.33). Measures of sleep-related intermittent hypoxemia, but not sleep fragmentation, were independently associated with all-cause mortality. Coronary artery disease–related mortality associated with sleep-disordered breathing showed a pattern of association similar to all-cause mortality.
Conclusions
Sleep-disordered breathing is associated with all-cause mortality and specifically that due to coronary artery disease, particularly in men aged 40–70 y with severe sleep-disordered breathing.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
About 1 in 10 women and 1 in 4 men have a chronic condition called sleep-disordered breathing although most are unaware of their problem. Sleep-disordered breathing, which is commonest in middle-aged and elderly people, is characterized by numerous, brief (10 second or so) interruptions of breathing during sleep. These interruptions, which usually occur when relaxation of the upper airway muscles decreases airflow, lower the level of oxygen in the blood and, as a result, affected individuals are frequently aroused from deep sleep as they struggle to breathe. Symptoms of sleep-disordered breathing include loud snoring and daytime sleepiness. Treatments include lifestyle changes such as losing weight (excess fat around the neck increases airway collapse) and smoking cessation. Affected people can also use special devices to prevent them sleeping on their backs, but for severe sleep-disordered breathing, doctors often recommend continuous positive airway pressure (CPAP), a machine that pressurizes the upper airway through a face mask to keep it open.
Why Was This Study Done?
Sleep-disordered breathing is a serious condition. It is associated with several adverse health conditions including coronary artery disease (narrowing of the blood vessels that supply the heart, a condition that can cause a heart attack) and daytime sleepiness that can affect an individual's driving ability. In addition, several clinic- and community-based studies suggest that sleep-disordered sleeping may increase a person's risk of dying. However, because these studies have been small and have often failed to allow for other conditions and characteristics that affect an individual's risk of dying (“confounding factors”), they provide inconsistent or incomplete information about the potential association between sleep-disordered breathing and the risk of death. In this prospective cohort study (part of the Sleep Heart Health Study, which is researching the effects of sleep-disordered breathing on cardiovascular health), the researchers examine whether sleep-disordered breathing is associated with all-cause mortality (death from any cause) in a large community sample of adults. A prospective cohort study is one in which a group of participants is enrolled and then followed forward in time (in this case for several years) to see what happens to them.
What Did the Researchers Do and Find?
At enrollment, the study participants—more than 6,000 people aged 40 years or older, none of whom were being treated for sleep-disordered breathing—had a health examination. Their night-time breathing, sleep patterns, and blood oxygen levels were also assessed and these data used to calculate each participant's apnea-hypopnea index (AHI)—the number of apneas and hypopneas per hour. During the study follow-up period, 1,047 participants died. Compared to participants without sleep-disordered sleeping, participants with severe sleep-disordered breathing (an AHI of ≥30) were about one and a half times as likely to die from any cause after adjustment for potential confounding factors. People with milder sleep-disordered breathing did not have a statistically significant increased risk of dying. After dividing the participants into subgroups according to their age and sex, men aged 40–70 years with severe sleep-disordered breathing had a statistically increased risk of dying from any cause (twice the risk of men of a similar age without sleep-disordered breathing). Finally, death from coronary artery disease was also associated with sleep-disordered breathing in men but not in women.
What Do These Findings Mean?
These findings indicate that sleep-disordered breathing is associated with an increased risk of all-cause mortality, particularly in men aged 40–70 years, even after allowing for known confounding factors. They also suggest that the increased risk of death is specifically associated with coronary artery disease although further studies are needed to confirm this finding because it was based on the analysis of a small subgroup of study participants. Although this study is much larger than previous investigations into the association between sleep-disordered breathing and all-cause mortality, it has several limitations including its reliance on a single night's measurements for the diagnosis of sleep-disordered breathing. Nevertheless, these findings suggest that clinical trials should now be started to assess whether treatment can reduce the increased risk of death that seems to be associated with this common disorder.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000132.
The US National Heart Lung and Blood Institute has information (including a video) about sleep-disordered breathing (sleep apnea) (in English and Spanish)
The UK National Heath Service also provides information for patients about sleep apnea
MedlinePlus provides links to further information and advice about sleep-disordered breathing (in English and Spanish)
More information on the Sleep Heart Health Study is available
doi:10.1371/journal.pmed.1000132
PMCID: PMC2722083  PMID: 19688045
23.  Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: randomised controlled trial 
Objective To examine whether behavioural strategies designed to improve children’s sleep problems could also improve the symptoms, behaviour, daily functioning, and working memory of children with attention deficit hyperactivity disorder (ADHD) and the mental health of their parents.
Design Randomised controlled trial.
Setting 21 general paediatric practices in Victoria, Australia.
Participants 244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012.
Intervention Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call. Children in the control group received usual clinical care.
Main outcome measures At three and six months after randomisation: severity of ADHD symptoms (parent and teacher ADHD rating scale IV—primary outcome), sleep problems (parent reported severity, children’s sleep habits questionnaire, actigraphy), behaviour (strengths and difficulties questionnaire), quality of life (pediatric quality of life inventory 4.0), daily functioning (daily parent rating of evening and morning behavior), working memory (working memory test battery for children, six months only), and parent mental health (depression anxiety stress scales).
Results Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months (adjusted mean difference for change in symptom severity −2.9, 95% confidence interval −5.5 to −0.3, P=0.03, effect size −0.3, and −3.7, −6.1 to −1.2, P=0.004, effect size −0.4, respectively). Compared with control children, intervention children had fewer moderate-severe sleep problems at three months (56% v 30%; adjusted odds ratio 0.30, 95% confidence interval 0.16 to 0.59; P<0.001) and six months (46% v 34%; 0.58, 0.32 to 1.0; P=0.07). At three months this equated to a reduction in absolute risk of 25.7% (95% confidence interval 14.1% to 37.3%) and an estimated number needed to treat of 3.9. At six months the number needed to treat was 7.8. Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep, at three and six months, respectively. Intervention families reported greater improvements in all other child and family outcomes except parental mental health. Teachers reported improved behaviour of the children at three and six months. Working memory (backwards digit recall) was higher in the intervention children compared with control children at six months. Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months (mean difference 10.9 minutes, 95% confidence interval −19.0 to 40.8 minutes, effect size 0.2) and six months (9.9 minutes, −16.3 to 36.1 minutes, effect size 0.3); however, this measure was only completed by a subset of children (n=54 at three months and n=37 at six months).
Conclusions A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD, most of whom were taking stimulant medications. The intervention also improved the children’s sleep, behaviour, quality of life, and functioning, with most benefits sustained to six months post-intervention. The intervention may be suitable for use in primary and secondary care.
Trial registration Current Controlled Trials ISRCTN68819261.
doi:10.1136/bmj.h68
PMCID: PMC4299655  PMID: 25646809
24.  Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth 
BMC Public Health  2011;11:942.
Background
Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz) study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care.
Methods/Design
This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years) or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months) and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry), duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use). This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia.
Discussion
Infancy is likely to be the most effective time to establish patterns of behaviour around food, activity and sleep that promote healthy child and adult weight. The POI.nz study will determine the extent to which sleep, food and activity interventions in infancy prevent the development of overweight.
Trial Registration
Clinical Trials NCT00892983
Prospective meta-analysis registered on PROSPERO CRD420111188. Available from http://www.crd.york.ac.uk/PROSPERO
doi:10.1186/1471-2458-11-942
PMCID: PMC3293097  PMID: 22182309
25.  Sleep well—be well study: improving school transition by improving child sleep: a translational randomised trial 
BMJ Open  2013;3(10):e004009.
Introduction
The transition to primary school appears crucial for a child's future academic and psychological well-being. Addressing conditions which negatively affect children during this period, such as poor sleep, may improve these outcomes. Sleep problems are common and in a previous efficacy randomised controlled trial, we demonstrated that sleep problems can be identified and improved using school-based screening followed by a brief behavioural intervention. This trial will determine whether the same intervention is beneficial and cost-effective when delivered by an existing school-based health workforce.
Methods/design
We will recruit 334 children with sleep problems from approximately 40 schools after screening for behavioural sleep problems in the first year of formal education (Grade Prep). Schools in Melbourne, Australia will be invited to participate from a randomly ordered list of eligible schools and we will approach all caregivers of Grade Prep children. Children who have a parent-reported moderate or severe sleep problem will be randomised into either ‘usual care’ or ‘intervention’ groups. Trained nurses from the Primary School Nursing programme will deliver the sleep intervention programme. Intervention: Two to three contacts between the nurse and the parent; initial 45 min face-to-face meeting or phone call, 15 min phone call 2 weeks later and an optional second 30 min face-to-face meeting. Follow-up: 6 and 12 months postrandomisation using parent and teacher surveys and child face-to-face assessments. Primary outcome: child psychosocial functioning at 6 months. Secondary outcomes: child psychosocial functioning at 12 months and child sleep, behaviour, working memory, academic achievement and parent mental health at 6 and 12 months. Cost-effectiveness analysis will compare incremental costs to difference in child psychosocial functioning at 6 months.
Registration
International Standard Randomised Controlled Trial Number Register (ISRCTN92448857).
doi:10.1136/bmjopen-2013-004009
PMCID: PMC3816243  PMID: 24165031

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