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1.  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
2.  Long term cognitive development in children with prolonged crying 
Archives of Disease in Childhood  2004;89(11):989-992.
Background: Long term studies of cognitive development and colic have not differentiated between typical colic and prolonged crying.
Objective: To evaluate whether colic and excessive crying that persists beyond 3 months is associated with adverse cognitive development.
Design: Prospective cohort study. A sample of 561 women was enrolled in the second trimester of pregnancy. Colic and prolonged crying were based on crying behaviour assessed at 6 and 13 weeks. Children's intelligence, motor abilities, and behaviour were measured at 5 years (n = 327). Known risk factors for cognitive impairment were ascertained prenatally, after birth, at 6 and 13 weeks, at 6, 9, and 13 months, and at 5 years of age.
Results: Children with prolonged crying (but not those with colic only) had an adjusted mean IQ that was 9 points lower than the control group. Their performance and verbal IQ scores were 9.2 and 6.7 points lower than the control group, respectively. The prolonged crying group also had significantly poorer fine motor abilities compared with the control group. Colic had no effect on cognitive development.
Conclusions: Excessive, uncontrolled crying that persists beyond 3 months of age in infants without other signs of neurological damage may be a marker for cognitive deficits during childhood. Such infants need to be examined and followed up more intensively.
doi:10.1136/adc.2003.039198
PMCID: PMC1719720  PMID: 15499048
3.  Parental diary of infant cry and fuss behaviour. 
Archives of Disease in Childhood  1988;63(4):380-387.
Despite their common use parental diaries of infants' cry and fuss behaviour have not been compared with objective methods of recording. To understand what is meant by the descriptions of crying and fussing in the diaries, the diaries of 10 mothers of 6 week old infants were compared with tape recordings of vocalisations made by the babies over a 24 hour period. There were moderately strong correlations between the frequency of episodes (clusters of 'negative vocalisations') on the audiotape and episodes of 'crying and fussing' in the diaries, and between the duration of episodes on the audiotape and episodes of 'crying' in the diaries. To assess the acceptability of the diaries for recording information for clinical and epidemiological research, they were then used in a population study of a wide socioeconomic group. Usable data were obtained from 91% of the sample. The results suggest that despite pronounced differences between recording methods, these diaries may provide valid and useful reports of crying and fussing in the short term.
PMCID: PMC1778809  PMID: 3365007
4.  When and why are babies weaned? 
British Medical Journal  1978;1(6128):1682-1683.
A prospective study was designed to investigate the weaning practices of 50 primiparous mothers whose babies were born between September 1976 and March 1978. The question whether the age of weaning influenced growth from birth to 6 months was also considered. The mothers and babies were seen in hospital and then at a follow-up clinic at 1, 2, 3, and 6 months. Details were taken of feeding practices, and measurements made of the babies' weight, length, and subscapular and triceps skinfold thicknesses. Seventeen infants who were breastfed received their first solid food at a mean age of 13.8 weeks, compared with 8.3 weeks for the 33 bottle-fed infants. Most (38) mothers weaned because they though their babies were hungry (crying after a feed or demanding more frequent feeds, or both). The age of weaning did not influence weight gain, growth in length, or change in skinfold thicknesses. The results suggest that the "4-month rule" for weaning is unrealistic. The decision to wean should be based more on the mother's interpretation of her baby's needs than on age alone.
PMCID: PMC1605471  PMID: 656873
5.  Maternal brain response to own baby-cry is affected by cesarean section delivery 
A range of early circumstances surrounding the birth of a child affects peripartum hormones, parental behavior and infant wellbeing. One of these factors, which may lead to postpartum depression, is the mode of delivery: vaginal delivery (VD) or cesarean section delivery (CSD). To test the hypothesis that CSD mothers would be less responsive to own baby-cry stimuli than VD mothers in the immediate postpartum period, we conducted functional magnetic resonance imaging, 2–4 weeks after delivery, of the brains of six mothers who delivered vaginally and six who had an elective CSD. VD mothers’ brains were significantly more responsive than CSD mothers’ brains to their own baby-cry in the superior and middle temporal gyri, superior frontal gyrus, medial fusiform gyrus, superior parietal lobe, as well as regions of the caudate, thalamus, hypothalamus, amygdala and pons. Also, within preferentially active regions of VD brains, there were correlations across all 12 mothers with out-of-magnet variables. These include correlations between own baby-cry responses in the left and right lenticular nuclei and parental preoccupations (r = .64, p < .05 and .67, p < .05 respectively), as well as in the superior frontal cortex and Beck depression inventory (r = .78, p < .01). First this suggests that VD mothers are more sensitive to own baby-cry than CSD mothers in the early postpartum in sensory processing, empathy, arousal, motivation, reward and habit-regulation circuits. Second, independent of mode of delivery, parental worries and mood are related to specific brain activations in response to own baby-cry.
doi:10.1111/j.1469-7610.2008.01963.x
PMCID: PMC3246837  PMID: 18771508
Parenting; cesarean section; maternal behavior; brain imaging; fMRI; empathy; infant
6.  Crying babies, tired mothers - challenges of the postnatal hospital stay: an interpretive phenomenological study 
Background
According to an old Swiss proverb, "a new mother lazing in childbed is a blessing to her family". Today mothers rarely enjoy restful days after birth, but enter directly into the challenge of combining baby- and self-care. They often face a combination of infant crying and personal tiredness. Yet, routine postnatal care often lacks effective strategies to alleviate these challenges which can adversely affect family health. We explored how new mothers experience and handle postnatal infant crying and their own tiredness in the context of changing hospital care practices in Switzerland.
Methods
Purposeful sampling was used to enroll 15 mothers of diverse parity and educational backgrounds, all of who had given birth to a full term healthy neonate. Using interpretive phenomenology, we analyzed interview and participant observation data collected during the postnatal hospital stay and at 6 and 12 weeks post birth. This paper reports on the postnatal hospital experience.
Results
Women's personal beliefs about beneficial childcare practices shaped how they cared for their newborn's and their own needs during the early postnatal period in the hospital. These beliefs ranged from an infant-centered approach focused on the infant's development of a basic sense of trust to an approach that balanced the infants' demands with the mother's personal needs. Getting adequate rest was particularly difficult for mothers striving to provide infant-centered care for an unsettled neonate. These mothers suffered from sleep deprivation and severe tiredness unless they were able to leave the baby with health professionals for several hours during the night.
Conclusion
New mothers often need permission to attend to their own needs, as well as practical support with childcare to recover from birth especially when neonates are fussy. To strengthen family health from the earliest stage, postnatal care should establish conditions which enable new mothers to balance the care of their infant with their own needs.
doi:10.1186/1471-2393-10-21
PMCID: PMC2879231  PMID: 20462462
7.  Bases for maternal perceptions of infant crying and colic behaviour. 
Archives of Disease in Childhood  1996;75(5):375-384.
According to the commonest definition, infant colic is distinguished by crying which is 'paroxysmal'-that is, intense and different in type from normal fussing and crying. To test this, maternal reports of the distress type of 67 infants whose fuss/crying usually exceeded three hours a day ('persistent criers') were scrutinised using 24 hour audiorecordings of the infants' distressed vocalisation. 'Moderate criers' (n = 55) and 'evening criers' (n = 38) were also assessed. Most of the distress in all three groups was fussing. In the audiorecordings the persistent criers showed a higher crying: fussing ratio than the moderate criers, but intense crying was rare. A third of the persistent criers were reported by their mothers to have occasional, distinct colic bouts of 'intense, unsoothable crying and other behaviour, perhaps due to stomach or bowel pain.' In the audiorecordings these periods were longer, but not paroxysmal in onset or more intense than the crying of persistent criers not judged to have colic. The audible features of the crying may be less important than its unpredictable, prolonged, hard to soothe, and unexplained nature.
PMCID: PMC1511785  PMID: 8957949
8.  Crystal violet reactions of Staphylococcus aureus strains colonizing infants in the first six weeks. 
Epidemiology and Infection  1993;110(1):79-86.
Nasal colonization with Staphylococcus aureus occurred in 18% of babies leaving a maternity unit and had risen to 40% by 6 weeks after birth. S. aureus was first acquired by 34.5% of babies after discharge. Female infants were more likely to be colonized than males. Colonization was not significantly different between babies receiving standard postnatal care and those nursed on the Special Care Baby Unit. Crystal violet (CV) tests showed that purple-reacting isolates accounted for approximately 60% of strains, whether first detected at hospital discharge or subsequently acquired. Purple-reacting strains, once acquired, were significantly better able to persist than non purple-reacting strains and formed a cumulatively higher proportion of the strains isolated at 6 weeks after birth than at hospital discharge. CV purple-reactions were significantly associated with lysis by phages of groups III and I and non-purple-reactions were significantly associated with lysis by phages of group II and/or 94/96. Maternity units remain a significant route whereby strains of S. aureus with some characteristics associated with a hospital origin gain access to the community.
PMCID: PMC2271961  PMID: 8432326
9.  The analgesic effect of sucrose in full term infants: a randomised controlled trial. 
BMJ : British Medical Journal  1995;310(6993):1498-1500.
OBJECTIVE--To evaluate the effects of different sucrose concentrations on measures of neonatal pain. DESIGN--Randomised, double blind, placebo controlled trial of sterile water (control) or one of three solutions of sucrose--namely, 12.5%, 25%, and 50% wt/vol. SETTING--Postnatal ward. PATIENTS--60 healthy infants of gestational age 37-42 weeks and postnatal age 1-6 days randomised to receive 2 ml of one of the four solutions on to the tongue two minutes before heel prick sampling for serum bilirubin concentrations. MAIN OUTCOME MEASURE--Duration of crying over the first three minutes after heel prick. RESULTS--There was a significant reduction in overall crying time and heart rate after three minutes in the babies given 50% sucrose as compared with controls. This was maximal one minute after heel prick in the 50% sucrose group and became statistically significant in the 25% sucrose group at two minutes. There was a significant trend for a reduction in crying time with increasing concentrations of sucrose over the first three minutes. CONCLUSION--Concentrated sucrose solution seems to reduce crying and the autonomic effects of a painful procedure in healthy normal babies. Sucrose may be a useful and safe analgesic for minor procedures in neonates.
PMCID: PMC2549876  PMID: 7787595
10.  Bystanders affect the outcome of mother–infant interactions in rhesus macaques 
Animal communication involves the transfer of information between a sender and one or more receivers. However, such interactions do not happen in a social vacuum; third parties are typically present, who can potentially eavesdrop upon or intervene in the interaction. The importance of such bystanders in shaping the outcome of communicative interactions has been widely studied in humans, but has only recently received attention in other animal species. Here, we studied bouts of infant crying among rhesus macaques (Macaca mulatta) in order to investigate how the presence of bystanders may affect the outcome of this signalling interaction between infants and mothers. It was hypothesized that, as crying is acoustically aversive, bystanders may be aggressive to the mother or the infant in order to bring the crying bout to a close. Consequently, it was predicted that mothers should acquiesce more often to crying if in the presence of potentially aggressive animals. In line with this prediction, it was found that mothers gave infants access to the nipple significantly more often when crying occurred in the presence of animals that posed a high risk of aggression towards them. Both mothers and infants tended to receive more aggression from bystanders during crying bouts than outside of this time, although such aggression was extremely rare and was received by less than half of the mothers and infants in the study. Mothers were also found to be significantly more aggressive to their infants while the latter were crying than outside of crying bouts. These results provide new insight into the complex dynamics of mother–offspring conflict, and indicate that bystanders may play an important role in shaping the outcome of signalling interactions between infants and their mothers.
doi:10.1098/rspb.2009.0103
PMCID: PMC2677605  PMID: 19324744
bystanders; audience; communication; crying; mother–offspring conflict; rhesus macaque
11.  Breastfeeding, Brain Activation to Own Infant Cry, and Maternal Sensitivity 
Background
Research points to the importance of breastfeeding for promoting close mother-infant contact and social-emotional development. Recent functional magnetic resonance imaging (fMRI) studies have identified brain regions related to maternal behaviors. However, little research has addressed the neurobiological mechanisms underlying the relationship between breastfeeding and maternal behavior in human mothers. We investigated the associations between breastfeeding, maternal brain response to own infant stimuli, and maternal sensitivity in the early postpartum.
Methods
Seventeen biological mothers of healthy infants participated in two matched groups according to feeding method – exclusive breastfeeding and exclusive formula-feeding at 2-4 weeks postpartum. fMRI scanning was conducted in the first postpartum month to examine maternal brain activation in response to her own baby's cry versus control baby-cry. Dyadic interactions between mothers and infants at 3-4 months postpartum were videotaped in the home and blindly coded for maternal sensitivity.
Results
In the first postpartum month, breastfeeding mothers showed greater activations in the superior frontal gyrus, insula, precuneus, striatum, and amygdala while listening to their own baby-cry as compared to formula-feeding mothers. For both breastfeeding and formula-feeding mothers, greater activations in the right superior frontal gyrus and amygdala were associated with higher maternal sensitivity at 3-4 months postpartum.
Conclusions
Results suggest links between breastfeeding and greater response to infant cues in brain regions implicated in maternal-infant bonding and empathy during the early postpartum. Such brain activations may facilitate greater maternal sensitivity as infants enter their social world.
doi:10.1111/j.1469-7610.2011.02406.x
PMCID: PMC3134570  PMID: 21501165
breastfeeding; infancy; maternal sensitivity; mother-infant interaction; neuroimaging
12.  Prognostic significance of subgroup classification for infant patients with crying disorders: A prospective cohort study 
Introduction:
Few convincing treatment options have been identified for the excessively crying infant. One explanation may be a lack of identification of patient subgroups. This study used a clinically plausible categorization protocol to subgroup infants and compared changes in symptoms between these subgroups during treatment.
Methods:
An observational cohort design was employed. All infants presenting with excessive infant crying between July 2007 and March 2008 were categorized into three subgroups, (A) infant colic, (B) irritable infant syndrome of musculoskeletal origin (IISMO) and (C) inefficient feeding crying infants with disordered sleep (IFCIDS) based on history and physical findings. Mothers completed questionnaires which rated their own and their child’s characteristics prior to and at the end, of a course of manual therapy. Independent associations between infant subgroups and changes in continuous outcomes (crying, stress, sleep, and consolability) were assessed. Multivariable analysis of covariance was used to identify and control for potential confounders.
Results:
A total of 158 infants were enrolled. There was no significant difference in demographic profile between groups or any significant difference in infant crying or level of maternal stress at the start. Only the putative subgroups were significantly associated with differences in outcomes. In general, colic babies improved the most in consolability and crying.
Conclusion:
Babies with excessive crying should not be viewed as a homogenous group. Treatment outcomes may be improved by targeting appropriate subgroups prior to treatment.
PMCID: PMC3280117  PMID: 22457540
Subgroups; infant colic; excessive crying of infancy; Sous-groupes; colique du nourrisson; pleurs excessifs du nourrisson
13.  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
14.  Maternal Holding of Preterm Infants During the Early Weeks After Birth and Dyad Interaction at Six Months 
Objective
To examine whether a supportive nursing intervention that promoted kangaroo holding of healthy preterm infants by their mothers during the early weeks of the infant’s life facilitated co-regulation between mother and infant at six months of age.
Design
Randomized controlled trial.
Participants
Sixty-five mother-infant dyads with mean gestational age at birth of 33 weeks. Fifty percent of infants were male, and 50% were non-White.
Interventions
An eight week home intervention encouraged daily one hour, uninterrupted holding with either blanket (baby wrapped in blanket and held in mother’s arms) or the kangaroo (baby in skin-to-skin contact on mother’s chest) method. In both conditions, weekly home visits by an experienced RN included encouragement to hold the infant, emotional support, and information about infant behavior and development. A control group received brief social visits, had no holding constraints, and participated in all assessments.
Main Outcome Measures
When infants were six months of age, the Still-Face Procedure was used to assess mother-infant interaction. Outcome measures were co-regulation of the dyad’s responses during the play episodes of the Still Face Procedure and vitality in infant efforts to re-engage the mother during the neutral face portion of the Still Face procedure.
Results
Significant differences among groups were found in mother-infant co-regulation. Post hoc analysis showed that dyads who were supported in kangaroo holding displayed more co-regulation behavior during play than dyads in the blanket holding group. No differences were found between groups in infant vitality during the neutral face portion of the Still Face Procedure.
Conclusion
Dyads supported in practicing kangaroo holding in the early weeks of life may develop more co-regulated interactional strategies than other dyads.
doi:10.1111/j.1552-6909.2010.01152.x
PMCID: PMC2935695  PMID: 20629927
Prematurity; NICU; Still Face; Mother-infant; holding; intervention
15.  Clinical Usefulness of Maternal Odor in Newborns: Soothing and Feeding Preparatory Responses 
Biology of the neonate  1998;74(6):402-408.
This study assessed the responsiveness of newborn breast- and bottle-fed infants to presentations of maternal odor. Maternal odor was presented for 1 min to crying, sleeping or awake newborns. The odors were: (1) own mother’s odor - presentation of a hospital gown worn by the baby’s mother, (2) other mother’s odor - presentation of a hospital gown of another newborn baby’s mother, (3) clean gown - presentation of a clean hospital gown and (4) no gown - no gown presented. The results indicated that crying babies stopped crying when either own mother or other mother odor was presented. Awake babies responded specifically to their own mother’s odor by increasing mouthing. These results suggest that the practice of presenting the mother’s odor to a distressed infant is of clinical usefulness since it was capable of attenuating crying. The results also characterized a role for maternal odor with respect to feeding since presentation of the infant’s own mother odor increased mouthing. Thus, presentation of maternal odor may also be useful in enhancing nipple acceptance and feeding in newborns.
PMCID: PMC2046216  PMID: 9784631
Maternal odor; Mother-infant interactions; Feeding preparation; Soothing; Olfaction; Crying
16.  Prevention of shaken baby syndrome: Never shake a baby 
Paediatrics & Child Health  2004;9(5):319-321.
Shaken baby syndrome (SBS) represents injuries to the head, skeleton and eyes of a young child and is the leading cause of fatal or life-threatening child abuse. SBS is preventable. The dangers and consequences of shaking a baby are not well appreciated by the general public. Simple educational programs and community nursing support programs have been shown to be helpful. Inadequate physician training and knowledge in child maltreatment have also been identified as problems. This article outlines the evidence for interventions in the prevention of SBS and recommendations for health care providers and educators.
PMCID: PMC2721176  PMID: 19657516
Child abuse; Head injury; Prevention; Public health; Shaken baby syndrome
17.  Breath hydrogen excretion in infants with colic. 
Archives of Disease in Childhood  1989;64(5):725-729.
Breath hydrogen excretion as an index of incomplete lactose absorption was measured in 118 healthy infants who were either breast fed or given a formula feed containing lactose, some of whom had colic. Infants with colic (n = 65) were selected on the basis of the mother's report of a history of inconsolable crying lasting several hours each day. Infants in the control group (n = 53) were not reported to cry excessively by their mothers. Breath samples were collected using a face mask sampling device preprandially, and 90 and 150 minutes after the start of a feed. Normalised breath hydrogen concentrations were higher in the group with colic than in the control group at each time point. The median maximum breath hydrogen concentration in the colic group was 29 ppm, and in the control group 11 ppm. The percentage of infants with incomplete lactose absorption (breath hydrogen concentration more than 20 ppm) in the colic group was 62% compared with 32% in the control group. The clinical importance of the observed association between increased breath hydrogen excretion and infantile colic remains to be determined. Increased breath hydrogen excretion indicative of incomplete lactose absorption may be either a cause or an effect of colic in infants.
PMCID: PMC1792036  PMID: 2730128
18.  Effect of Kangaroo Care (skin contact) on crying response to pain in preterm neonates 
Objectives
When preterm infants experience heel stick, crying commonly occurs and has adverse physical effects. A reduction in crying is desired. Kangaroo Care, skin contact between mother and infant, reduces pain as measured by the Premature Infant Pain Profile, and may reduce crying time. The purpose of the pilot was to test Kangaroo Care's effect on the preterm infant's crying response to heel-stick.
Methods
A prospective cross-over study with 10 prematures 2-9 days old (30-32 weeks postmenstrual age) was conducted. Infants were randomly assigned to two sequences (Day 1 heel stick in Kangaroo Care [after 30 minutes of prone skin contact upright between maternal breasts] and Day 2 heel stick in incubator [inclined, nested and prone] or the opposite sequence) was conducted. Video tapes of Baseline, Heel Warming, Heel Stick, and Recovery phases were independently scored for audible and inaudible crying times by two research assistants. The audible and inaudible crying times for each subject in each phase were summed and the mean between the scorer's values was analyzed by repeated measures ANOVA.
Results
Subject characteristics did not differ between those in the two sequences. Crying time differed between the study phases on both days (p ≤ 0.001). When in Kangaroo Care as compared to the incubator, crying time was less during the Heel stick (p = 0.001) and Recovery (p = 0.01) phases.
Conclusion
Because Kangaroo Care reduced crying in response to heel stick in medically stable preterm infants who were 2-9 days old, a definitive study is recommended.
doi:10.1016/j.pmn.2007.11.004
PMCID: PMC2647362  PMID: 18513662
19.  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
20.  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
21.  Randomised controlled trial of eutectic mixture of local anaesthetics cream for venepuncture in healthy preterm infants 
AIM—To assess the safety and efficacy of EMLA cream (eutectic mixture of local anaesthetics) used to induce surface anaesthesia for venepuncture in healthy preterm infants.
METHODS—Nineteen infants, median gestational age 31 weeks (range 26-33 weeks) were assessed in a randomised, double blind, placebo controlled, cross-over trial. Changes in physiological variables (heart rate, blood pressure, oxygen saturation) and behavioural responses (neonatal facial coding system score, crying time) before and after venepuncture with EMLA cream were compared with those obtained with a placebo cream to assess efficacy. Toxicity was assessed by comparing methaemoglobin concentrations at 1 hour and 8 hours after application.
RESULTS—There was no significant difference in efficacy between EMLA and placebo creams in physiological and behavioural responses. There was no significant difference in methaemoglobin concentrations one hour after the cream had been applied. At eight hours, however, concentrations were significantly higher after EMLA than placebo (p=0.016). There was no evidence of clinical toxicity.
CONCLUSION—This study does not support the routine use of EMLA for venepuncture in healthy preterm infants.


PMCID: PMC1720755  PMID: 9577286
22.  Skin to skin contact for very low birthweight infants and their mothers. 
Archives of Disease in Childhood  1988;63(11):1377-1381.
Separation between mothers and very low birthweight infants is often prolonged with subsequent psychological distress, behaviour problems, and lactation failure. Babies as small as 700 g, who no longer require oxygen, can be safely and enjoyably held naked, except for a nappy, between the mother's breasts for up to four hours a day. We have carried out a randomised trial among babies less than 1500 g. Seventy one infants were randomised. In 35, the mother was helped to hold her baby in skin to skin contact and encouraged to do so whenever she visited the baby. In 36, the mother was encouraged to handle her baby but without skin to skin contact. Mothers using skin to skin contact lactated for four weeks longer on average than the control group. At 6 months of age the infants who had skin to skin contact cried significantly less than the control group. Skin to skin contact can safely and enjoyably be offered to very low birthweight infants especially in developing countries where the mother's lactation is vital.
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PMCID: PMC1779160  PMID: 3060024
23.  Effects of Nurse Home Visiting on Maternal and Child Functioning: Age-9 Follow-up of a Randomized Trial 
Pediatrics  2007;120(4):e832-e845.
OBJECTIVE
Our goal was to test the effect of prenatal and infancy home visits by nurses on mothers’ fertility and children’s functioning 7 years after the program ended at child age 2.
METHODS
We conducted a randomized, controlled trial in a public system of obstetric and pediatric care. A total of 743 primarily black women <29 weeks’ gestation, with previous live births and at least 2 sociodemographic risk characteristics (unmarried, <12 years of education, unemployed), were randomly assigned to receive nurse home visits or comparison services. Primary outcomes consisted of intervals between births of first and second children and number of children born per year; mothers’ stability of relationships with partners and relationships with the biological father of the child; mothers’ use of welfare, food stamps, and Medicaid; mothers’ use of substances; mothers’ arrests and incarcerations; and children’s academic achievement, school conduct, and mental disorders. Secondary outcomes were the sequelae of subsequent pregnancies, women’s employment, experience of domestic violence, and children’s mortality.
RESULTS
Nurse-visited women had longer intervals between births of first and second children, fewer cumulative subsequent births per year, and longer relationships with current partners. From birth through child age 9, nurse-visited women used welfare and food stamps for fewer months. Nurse-visited children born to mothers with low psychological resources, compared with control-group counterparts, had better grade-point averages and achievement test scores in math and reading in grades 1 through 3. Nurse-visited children, as a trend, were less likely to die from birth through age 9, an effect accounted for by deaths that were attributable to potentially preventable causes.
CONCLUSIONS
By child age 9, the program reduced women’s rates of subsequent births, increased the intervals between the births of first and second children, increased the stability of their relationships with partners, facilitated children’s academic adjustment to elementary school, and seems to have reduced childhood mortality from preventable causes.
doi:10.1542/peds.2006-2111
PMCID: PMC2839449  PMID: 17908740
home visits; pregnancy; welfare; child development; mortality
24.  Effectiveness of treatments for infantile colic: systematic review 
BMJ : British Medical Journal  1998;316(7144):1563-1569.
Objective: To evaluate the effectiveness of diets, drug treatment, and behavioural interventions on infantile colic in trials with crying or the presence of colic as the primary outcome measure.
Data sources: Controlled clinical trials identified by a highly sensitive search strategy in Medline (1966-96), Embase (1986-95), and the Cochrane Controlled Trials Register, in combination with reference checking for further relevant publications. Keywords were crying and colic.
Study selection: Two independent assessors selected controlled trials with interventions lasting at least 3 days that included infants younger than 6 months who cried excessively.
Data synthesis: Methodological quality was assessed by two assessors independently with a quality assessment scale (range 0-5). Effect sizes were calculated as percentage success. Effect sizes of trials using identical interventions were pooled using a random effects model.
Results: 27 controlled trials were identified. Elimination of cows’ milk protein was effective when substituted by hypoallergenic formula milks (effect size 0.22 (95% confidence interval 0.09 to 0.34)). The effectiveness of substitution by soy formula milks was unclear when only trials of good methodological quality were considered. The benefit of eliminating cows’ milk protein was not restricted to highly selected populations. Dicyclomine was effective (effect size 0.46 ( 0.33 to 0.60)), but serious side effects have been reported. The advice to reduce stimulation was beneficial (effect size 0.48 (0.23 to 0.74)), whereas the advice to increase carrying and holding seemed not to reduce crying. No benefit was shown for simethicone. Uncertainty remained about the effectiveness of low lactose formula milks.
Conclusions: Infantile colic should preferably be treated by advising carers to reduce stimulation and with a one week trial of a hypoallergenic formula milk.
Key messages Infantile colic is common during the first months of life, but its cause is unknown A definite diagnosis of infantile colic should be followed by a one week trial of substituting cows’ milk with hypoallergenic formula milk Dietary intervention should be combined with behavioural interventions: general advice, reassurance, reduction in stimuli, and sensitive differential responding (teaching parents to be more appropriately responsive to their infants with less overstimulation and more effective soothing) Anticholinergic drugs are not recommended because of their serious side effects
PMCID: PMC28556  PMID: 9596593
25.  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

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