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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.
To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression.
Randomised controlled trial.
Well child clinics, Melbourne, Australia
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.
Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations.
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.
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.  Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 
BMC Pediatrics  2012;12:135.
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.
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.
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
PMCID: PMC3508922  PMID: 22928654
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota
3.  The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial 
BMC Pediatrics  2012;12:76.
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.
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.
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
PMCID: PMC3464160  PMID: 22709245
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.
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 
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.
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.
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.
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.
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.
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).
Data from two longitudinal studies are analysed. Infant crying data were obtained from validated behaviour diaries; sleep-waking data from standard parental questionnaires.
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.
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.
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.

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.
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.
Cluster randomised trial.
49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.
328 mothers reporting an infant sleep problem at 7 months recruited during October–November 2003.
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.
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.
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).
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.
PMCID: PMC3603553  PMID: 23516146
10.  The contribution of Australian residential early parenting centres to comprehensive mental health care for mothers of infants: evidence from a prospective study 
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.
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.
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.
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.
PMCID: PMC2873569  PMID: 20380739
11.  Sleep and breathing in premature infants at 6 months post-natal age 
BMC Pediatrics  2014;14:303.
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.
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.
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.
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.
PMCID: PMC4272529  PMID: 25510740
Sleep questionnaire; Sleep-disordered breathing; Prematurity; Full-term infant
12.  Prem Baby Triple P: a randomised controlled trial of enhanced parenting capacity to improve developmental outcomes in preterm infants 
BMC Pediatrics  2015;15:15.
Very preterm birth (<32 weeks gestation) is associated with motor, cognitive, behavioural and educational problems in children and maternal depression and withdrawal. Early interventions that target parenting have the greatest potential to create sustained effects on child development and parental psychopathology. Triple P (Positive Parenting Program) has shown positive effects on child behaviour and adjustment, parenting practices and family functioning. Baby Triple P for Preterm infants, has been developed to target parents of very preterm infants. This study tests the effectiveness of Baby Triple P for Preterm infants in improving child and parent/couple outcomes at 24 months corrected age (CA).
Families will be randomised to receive either Baby Triple P for Preterm infants or Care as Usual (CAU). Baby Triple P for Preterm infants involves 4 × 2 hr group sessions at the hospital plus 4 × 30 min telephone consultations soon after transfer (42 weeks C.A.). After discharge participants will be linked to community based Triple P and intervention maintenance up to 24 months C.A. Assessments will be: baseline, post-intervention (6 weeks C.A.), at 12 and 24 months C.A. The primary outcome measure is the Infant Toddler Social & Emotional Assessment (ITSEA) at 24 months C.A. Child behavioural and emotional problems will be coded using the mother-toddler version of the Family Observation Schedule at 24 months C.A. Secondary outcome will be the Bayley Scales of Infant and Toddler Development (BSID III) cognitive development, language and motor abilities. Proximal targets of parenting style, parental self-efficacy, parental mental health, parental adjustment, parent-infant attachment, couple relationship satisfaction and couple communication will also be assessed. Our sample size based on the ITSEA, has 80% power, predicted effect size of 0.33 and an 85% retention rate, requires 165 families are required in each group (total sample of 330 families).
This protocol presents the study design, methods and intervention to be analysed in a randomised trial of Baby Triple P for Preterm infants compared to Care as Usual (CAU) for families of very preterm infants. Publications of all outcomes will be published in peer reviewed journals according to CONSORT guidelines.
Trial registration
Australian New Zealand Clinical Trials Registry: ACTRN12612000194864.
PMCID: PMC4363360  PMID: 25884634
Preterm infants; Behavioral family intervention; Child behavioral adjustment; Child emotional adjustment; Child cognitive and language development; Parenting support/education
13.  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.
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.
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
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
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
PMCID: PMC3210771  PMID: 22087079
14.  Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL 
Despite weak evidence, the use of acupuncture has increased in infantile colic. The only three randomized trials conducted evaluated standardized minimal acupuncture in one single point. Two showed effect but one did not so further research is necessary.
The aims of the study are 1) to test if results in earlier trials conducted in private acupuncture clinics can be repeated at Child Health Centers (CHC) and 2) to compare the effect of two types of acupuncture and no acupuncture in infants with colic at CHC.
a multicenter randomized controlled three-armed trial for infantile colic conducted in four regions of Sweden. Alongside the standard program at their regular Child Health Center infants visit a study center twice a week for 2 weeks. The infants are randomly allocated into three groups.
According to the power analysis, 144 otherwise healthy infants aged 2–9 weeks old, who – according to parents’ registration in a diary – are crying and/or fussing more than three hours per day, more than 3 days per week will be included. Parents register daily in the diary during the baseline week, two intervention weeks, and one more week directly after the last study visit.
At four study visits at the Child Health Center parents meet a nurse for 20–30 min to receive advice and support. The nurse and the parents are blinded for group allocation. Infants are carried to another room, where they spend five minutes with an acupuncturist. Infants randomized to group A receive standardized minimal acupuncture in LI4. Group B receive individualized acupuncture where, according to symptoms, the acupuncturist can choose between the points Sifeng, LI4, and ST36. Group C receives no acupuncture.
The primary outcome is relative difference in crying, counted in minutes. Secondary outcomes are number of infants fulfilling the criteria for colic, and changes in sleep and stooling frequency. Adverse events and blinding are recorded.
Recruitment started in January 2013. During the first 14 months 93 patients were included. Data collection continues until May 2015. No interim analyses have been conducted.
The study will provide information about the efficacy and safety of acupuncture as a complement to usual care in infants with colic.
Trial registration
December 29, 2012: NCT01761331
PMCID: PMC4570710  PMID: 26370560
15.  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.
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.
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 ISRCTN13968779
Please see later in the article for the Editors' Summary
Editors' Summary
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
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
PMCID: PMC3352861  PMID: 22615543
16.  GORD in children 
BMJ Clinical Evidence  2008;2008:0310.
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).
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.
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
17.  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.
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.
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.
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.
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.
PMCID: PMC2931475  PMID: 20718991
18.  Mothers' reports of infant crying and soothing in a multicultural population 
Archives of Disease in Childhood  1998;79(4):312-317.
OBJECTIVES—To investigate the prevalence of infant crying and maternal soothing techniques in relation to ethnic origin and other sociodemographic variables.
DESIGN—A questionnaire survey among mothers of 2-3 month old infants registered at six child health clinics in Amsterdam, the Netherlands.
SUBJECTS—A questionnaire on sociodemographic characteristics and crying behaviour was completed for 1826 of 2180 (84%) infants invited with their parents to visit the child health clinics. A questionnaire on soothing techniques was also filled out at home for 1142 (63%) of these infants.
RESULTS—Overall prevalences of "crying for three or more hours/24 hour day", "crying a lot", and "difficult to comfort" were 7.6%, 14.0%, and 10.3%, respectively. Problematic infant crying was reported by 20.3% of the mothers. Of these infants, only 14% met all three inclusion criteria. Problematic crying occurred less frequently among girls, second and later born children, Surinamese infants, and breast fed infants. Many mothers used soothing techniques that could affect their infant's health negatively. Shaking, slapping, and putting the baby to sleep in a prone position were more common among non-Dutch (especially Turkish) mothers than among Dutch mothers. Poorly educated mothers slapped their baby more often than highly educated mothers.
CONCLUSIONS—Mothers' reports of infant crying and soothing varied sociodemographically. Much harm may be prevented by counselling parents (especially immigrants) on how and how not to respond to infant crying. Health education should start before the child's birth, because certain soothing techniques could be fatal, even when practised for the first time.

PMCID: PMC1717709  PMID: 9875040
19.  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.
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.
PMCID: PMC4173107  PMID: 25248497
20.  An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness 
Trials  2013;14:210.
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.
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.
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
PMCID: PMC3717037  PMID: 23841920
Parenting; Substance misuse; Drug abuse; Alcohol abuse; Infants; Parents under pressure
21.  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.
PMCID: PMC4299655  PMID: 25646809
22.  Video Evidence That London Infants Can Resettle Themselves Back to Sleep After Waking in the Night, as well as Sleep for Long Periods, by 3 Months of Age 
This article has supplementary material on the Web site:
Most infants become settled at night by 3 months of age, whereas infants not settled by 5 months are likely to have long-term sleep-waking problems. We assessed whether normal infant development in the first 3 months involves increasing sleep-period length or the ability to resettle autonomously after waking in the night.
One hundred one infants were assessed at 5 weeks and 3 months of age using nighttime infrared video recordings and parental questionnaires.
The clearest development was in sleep length; 45% of infants slept continuously for ≥5 hours at night at 3 months compared with 10% at 5 weeks. In addition, around a quarter of infants woke and resettled themselves back to sleep in the night at each age. Autonomous resettling at 5 weeks predicted prolonged sleeping at 3 months suggesting it may be a developmental precursor. Infants reported by parents to sleep for a period of 5 hours or more included infants who resettled themselves and those with long sleeps. Three-month olds fed solely breast milk were as likely to self-resettle or have long sleep bouts as infants fed formula or mixed breast and formula milk.
Infants are capable of resettling themselves back to sleep in the first 3 months of age; both autonomous resettling and prolonged sleeping are involved in “sleeping through the night” at an early age. Findings indicate the need for physiological studies of how arousal, waking, and resettling develop into sustained sleeping and of how environmental factors support these endogenous and behavioral processes.
PMCID: PMC4459553  PMID: 26035139
infant sleeping; infant crying; settling; parenting
23.  Colic in infants 
BMJ Clinical Evidence  2010;2010:0309.
Colic in infants causes one in six families (17%) with children to consult a health professional. One systematic review of 15 community-based studies found a wide variation in prevalence, which depended on study design and method of recording.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for colic in infants? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (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).
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.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: advice to increase carrying, advice to reduce stimulation, casein hydrolysate milk, cranial osteopathy, crib vibrator device, focused counselling, gripe water, infant massage, low-lactose milk, simethicone, soya-based infant feeds, spinal manipulation, and whey hydrolysate milk.
Key Points
Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. The crying typically starts in the first few weeks of life and ends by age 4 to 5 months. It causes one in six families with children to consult a health professional.
We found insufficient RCT evidence to judge whether replacing cows' milk or breast milk with casein hydrolysate milk, low-lactose milk, soya-based infant feeds, or whey hydrolysate formula is effective in reducing crying time. Breastfeeding mothers should generally be encouraged to continue breastfeeding.Soya milk is associated with possible long-term harmful effects on reproductive health.
The RCTs examining the effects of reducing stimulation (by not patting, lifting, or jiggling the baby, or by reducing auditory stimulation), crib vibration, infant massage, focused counselling, or spinal manipulation were too small for us to draw reliable conclusions.
We found no good RCT evidence assessing cranial osteopathy or gripe water for treating colic in infants. Despite a lack of evidence from well-conducted trials, gripe water is commonly used by parents for their colicky infants.
Increasing the time spent carrying the infant (by at least 3 hours) does not seem to reduce the time spent crying, and may increase anxiety and stress in the parents.
RCTs identified assessing the effects of simethicone are of insufficient quality to draw reliable conclusions on the effectiveness of simethicone in treating colic.
PMCID: PMC2907620  PMID: 21729336
24.  Study protocol: the sleeping sound with attention-deficit/hyperactivity disorder project 
BMC Pediatrics  2010;10:101.
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.
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.
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.
PMCID: PMC3022790  PMID: 21192797
25.  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%.
PMCID: PMC1719431  PMID: 12538307

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