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1.  Excessive crying: behavioral and emotional regulation disorder in infancy 
Korean Journal of Pediatrics  2011;54(6):229-233.
In the pediatric literature, excessive crying has been reported solely in association with 3-month colic and is described, if at all, as unexplained crying and fussing during the first 3 months of life. The bouts of crying are generally thought to be triggered by abdominal colic (over-inflation of the still immature gastrointestinal tract), and treatment is prescribed accordingly. According to this line of reasoning, excessive crying is harmless and resolves by the end of the third month without long-term consequences. However, there is evidence that it may cause tremendous distress in the mother-infant relationship, and can lead to disorders of behavioral and emotional regulation at the toddler stage (such as sleep and feeding disorders, chronic fussiness, excessive clinginess, and temper tantrums). Early treatment of excessive crying focuses on parent-infant communication, and parent-infant interaction in the context of soothing and settling the infant to sleep is a promising approach that may prevent later behavioral and emotional disorders in infancy.
doi:10.3345/kjp.2011.54.6.229
PMCID: PMC3174357  PMID: 21949516
Excessive crying; Behavioral and emotional regulation disorder; Infant
2.  Infantile colic: Is there a role for dietary interventions? 
Paediatrics & Child Health  2011;16(1):47-49.
Infantile colic is a behavioural syndrome of early childhood that is associated with irritability and crying. It self-resolves, but may lead to significant parental strife. The etiology is unknown; however, several investigators have examined the effect of nutrition on infantile colic. For the majority of infants, nutritional interventions appear to have no benefit on infantile colic. However, a minority of infants may display symptoms of infantile colic secondary to a cow’s milk protein allergy. In these cases, a maternal hypoallergenic diet for breastfed infants and an extensively hydrolyzed formula for bottle-fed infants may result in resolution of colic. There is no proven role for the use of soy-based formulas or of lactase therapy in the management of infantile colic, and these interventions are not recommended. Currently, there are insufficient data to make a recommendation on the effect of probiotics for infantile colic. In all cases of infantile colic, it is important to ensure that there is sufficient parental support available.
PMCID: PMC3043028  PMID: 22211076
Infantile colic; Nutrition
3.  Infant colic and feeding difficulties 
Archives of Disease in Childhood  2004;89(10):908-912.
Aims: To examine the relation between colic and feeding difficulties and their impact on parental functioning for a primarily clinic referred sample.
Methods: Forty three infants (and their mothers) were enrolled between 6 and 8 weeks of age. Infants were divided into two groups, colic (n = 19) and comparison (n = 24), based on a modified Wessel rule of three criteria for colic. Families were assessed at two visits; one occurred in the laboratory and one occurred in a paediatric radiology office. Outcome measures included the clinical assessment of infant oral motor skills, behavioural observation of mother-infant feeding interactions, maternal questionnaires on infant crying, sleeping and feeding behaviours, and the occurrence of gastro-oesophageal reflux (GOR) in the infants using abdominal ultrasound.
Results: Infants in the colic group displayed more difficulties with feeding; including disorganised feeding behaviours, less rhythmic nutritive and non-nutritive sucking, more discomfort following feedings, and lower responsiveness during feeding interactions. Infants in the colic group also had more evidence of GOR based on the number of reflux episodes on abdominal ultrasound as well as maternal report of reflux. Mothers in the colic group reported higher levels of parenting stress.
Conclusions: Results provide the first systematic evidence of feeding problems in a subgroup of infants with colic. Data also illustrate the impact of these difficulties on parental and infant functioning. The association between feeding difficulties and colic suggests the potential for ongoing regulatory problems in infants presenting with clinically significant colic symptoms.
doi:10.1136/adc.2003.033233
PMCID: PMC1719691  PMID: 15383432
4.  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
5.  Treating infants’ colic 
Canadian Family Physician  2005;51(9):1209-1211.
QUESTION
Young parents often visit my office because their infants are crying inconsolably. Results of physical examination are unremarkable, so colic is the most likely cause. Colic has been known for many years, but I am unaware of any good remedy for it. Are there any modern, effective, safe methods of managing colic?
ANSWER
In most cases, colic is a “noisy phenomenon” for which there is no good explanation or treatment. Changing babies’ feedings rarely helps, and effective pharmacologic remedies are as yet unavailable. Several behavioural and complementary therapies have been suggested, but they have not been found effective. Addressing parental concerns and explaining about colic is the best solution until the colic goes away.
PMCID: PMC1479474  PMID: 16190173
6.  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
7.  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
8.  Feeding, stooling and sleeping patterns in infants with colic - a randomized controlled trial of minimal acupuncture 
Background
The aim was to describe the feeding- and stooling patterns of infants with colic and evaluate the influence of minimal acupuncture.
Methods
A prospective, randomized, controlled, blind clinical study was conducted at a private acupuncture clinic in Sweden. 90 otherwise healthy 2-8 weeks old infants, born after gestational week 36, fulfilling the criteria for infantile colic and not medicated with dicyclomine, were included. 81 infants went through a structured program consisting of six visits to the clinic, twice weekly. Infants randomized to receive acupuncture were given minimal, standardized acupuncture for two seconds in LI4. Frequency and size of stooling, as well as duration of, and intervals between, feeding sessions were reported by parents in a diary. Parental assessment of sleep and comments on stooling and side effects were collected in a questionnaire.
Results
At baseline when the mean age was five weeks, infants in both groups were fed a median of eight times/day, 148 min/day, with considerable variations. No differences were found between groups in the frequency and duration of feeding during the intervention weeks. Furthermore there were no significant differences between the groups regarding the frequency of stooling, neither at baseline, at which point the infants of both groups had bowel movements 4.2 times/day, nor during the intervention weeks. There was an expected decrease in frequency of stooling in both groups, reaching 2.1 (p = 0,001) in the acupuncture group and 3.1 (p < 0,001) in the control group. The groups differed regarding large bowel movements which decreased linearly in the control group (p = 0,011) but not in the acupuncture group (p = 0,787). More parents in the acupuncture group than in the control group (28% and 15% respectively, p = 0.006) experienced the infant's sleep to be "better" or "much better." No other significant differences were found. However, parents described a normalized stooling and experienced an improvement in colic in their infants more frequently in the acupuncture group than in the control group.
Conclusions
Infants with colic in the present study had a higher frequency of stooling than reported internationally in healthy infants. Minimal acupuncture had no major effect on feeding, stooling and sleep, although a minor effect of minimal acupuncture on stooling and sleep cannot be ruled out.
Trial registration
ClinicalTrials.govID NCT00860301
doi:10.1186/1472-6882-11-93
PMCID: PMC3212902  PMID: 21989212
9.  A behavioral model of infant sleep disturbance. 
Chronic sleep disturbance, such as bed refusal, sleep-onset delay, and night waking with crying, affects 15% to 35% of preschool children. Biological factors, particularly arousals associated with recurrent episodes of rapid-eye-movement sleep, render infants vulnerable to repeated awakenings. Parental failure to establish appropriate stimulus control of sleep-related behaviors and parent-mediated contingencies of reinforcement for sleep-incompatible behaviors may shape and maintain infant sleep disturbance. Treatment and prevention strategies are discussed, and research needs are identified.
doi:10.1901/jaba.1993.26-477
PMCID: PMC1297876  PMID: 8307835
10.  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
11.  Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression 
BMC Pediatrics  2012;12:13.
Background
Infant crying and sleep problems (e.g. frequent night waking, difficulties settling to sleep) each affect up to 30% of infants and often co-exist. They are costly to manage and associated with adverse outcomes including postnatal depression symptoms, early weaning from breast milk, and later child behaviour problems. Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system. Anticipatory guidance-i.e. providing parents with information about normal infant sleep and cry patterns, ways to encourage self-settling in infants, and ways to develop feeding and settling routines before the onset of problems-could prevent such problems. This paper outlines the protocol for our study which aims to test an anticipatory guidance approach.
Methods/Design
750 families from four Local Government Areas in Melbourne, Australia have been randomised to receive the Baby Business program (intervention group) or usual care (control group) offered by health services. The Baby Business program provides parents with information about infant sleep and crying via a DVD and booklet (mailed soon after birth), telephone consultation (at infant age 6-8 weeks) and parent group session (at infant age 12 weeks). All English speaking parents of healthy newborn infants born at > 32 weeks gestation and referred by their maternal and child health nurse at their first post partum home visit (day 7-10 postpartum), are eligible. The primary outcome is parent report of infant night time sleep as a problem at four months of age and secondary outcomes include parent report of infant daytime sleep or crying as a problem, mean duration of infant sleep and crying/24 hours, parental depression symptoms, parent sleep quality and quantity and health service use. Data will be collected at two weeks (baseline), four months and six months of age. An economic evaluation using a cost-consequences approach will, from a societal perspective, compare costs and health outcomes between the intervention and control groups.
Discussion
To our knowledge this is the first randomised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms. If effective, it could offer an important public health prevention approach to these common, distressing problems.
Trial registration number
ISRCTN: ISRCTN63834603
doi:10.1186/1471-2431-12-13
PMCID: PMC3292472  PMID: 22309617
12.  Infantile colic, facts and fiction 
Infantile colic is one of the major challenges of parenthood. It is one of the common reasons parents seek medical advice during their child’s first 3 months of life. It is defined as paroxysms of crying lasting more than 3 hours a day, occurring more than 3 days in any week for 3 weeks in a healthy baby aged 2 weeks to 4 months. Colic is a poorly understood phenomenon affecting up to 30% of babies, underlying organic causes of excessive crying account for less than 5%. Laboratory tests and radiological examinations are unnecessary if the infant is gaining weight normally and has a normal physical examination. Treatment is limited and drug treatment has no role in management. Probiotics are now emerging as promising agents in the treatment of infantile colic. Alternative medicine (Herbal tea, fennel, glucose and massage therapy) have not proved to be consistently helpful and some might even be dangerous. In conclusion infantile colic is a common cause of maternal distress and family disturbance, the cornerstone of management remains reassurance of parents regarding the benign and self-limiting nature of the illness. There is a critical need for more evidence based treatment protocols.
doi:10.1186/1824-7288-38-34
PMCID: PMC3411470  PMID: 22823993
Colic; Crying; Infant; Baby
13.  What is distinct about infants' "colic" cries? 
AIMS—To investigate (1) whether colic cries are acoustically distinct from pre-feed "hunger" cries; (2) the role of the acoustic properties of these cries versus their other properties in accounting for parents' concerns about colic.
DESIGN—From a community sample, infants were selected who met Wessel colic criteria for amounts of crying and whose mothers identified colic bouts. Using acoustic analyses, the most intense segments of nine colic bouts were compared with matched segments from pre-feed cries presumed to reflect hunger.
RESULTS—The colic cries did not have a higher pitch or proportion of dysphonation than the pre-feed cries. They did contain more frequent shorter utterances, but these resembled normal cries investigated in other studies. There is no evidence that colic cries have distinct acoustic features that are reproducible across samples and studies, which identify a discrete clinical condition, and which are identified accurately by parents.
CONCLUSIONS—The most reliable finding is that colic cries convey diffuse acoustic and audible information that a baby is highly aroused or distressed. Non-acoustic features, including the prolonged, hard to soothe, and unexplained nature of the cries may be specific to colic cries and more important for parents. These properties might reflect temperament-like dispositions.


PMCID: PMC1717780  PMID: 10325760
14.  Sleep and Attachment in Preterm Infants 
Infant mental health journal  2013;34(1):37-46.
Infants born preterm are at elevated risk for social emotional difficulties. However, factors contributing to this risk are largely understudied. Within the present study, we explored infant sleep as a biosocial factor that may play a role in infant social emotional development. Within a prospective longitudinal design, we examined parent-reported sleep patterns and observed parenting quality as predictors of infant-mother attachment in 171 infants born preterm. Using structural equation modeling, we examined main effect and moderator models linking infant sleep patterns and parenting with attachment security. Sleep patterns characterized by more daytime sleep and positive/responsive parenting predicted infant attachment security. Parent-reported nighttime sleep patterns were unrelated to attachment in this sample of infants born preterm. These results indicate that daytime sleep and parenting quality may be important for emerging attachment relationships in infants born preterm.
doi:10.1002/imhj.21374
PMCID: PMC3590002  PMID: 23482430
sleep; attachment; preterm
15.  Chiropractic diagnosis and management of non-musculoskeletal conditions in children and adolescents 
Background
A great deal has been published in the chiropractic literature regarding the response, or lack thereof, of various common pediatric conditions to chiropractic care. The majority of that literature is of low scientific value (that is, case reports or case series). The purpose of this review is to summarize the literature from the point of view of clinicians, rather than researchers, and to discuss some additional detail of the conditions themselves.
Methods
Databases searched were PubMed, Mantis, Index to Chiropractic Literature, and CINAHL. Keywords were chiropractic paired with colic, crying infant, nocturnal enuresis, asthma, otitis media and attention deficit hyperactivity disorder.
Results
Most of the published literature centers around case reports or series. The more scientifically rigorous studies show conflicting results for colic and the crying infant, and there is little data to suggest improvement of otitis media, asthma, nocturnal enuresis or attention deficit hyperactivity disorder.
Discussion
The efficacy of chiropractic care in the treatment of non-musculoskeletal disorders has yet to be definitely proven or disproven, with the burden of proof still resting upon the chiropractic profession.
doi:10.1186/1746-1340-18-14
PMCID: PMC2891801  PMID: 20525197
16.  Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study 
Background. Infantile colic is a distressing and common condition for which there is no proven standard treatment. Objective. To compare the efficacy of Mentha piperita with simethicone in treatment for infantile colic. Methods. A double-blind crossover study was performed with 30 infants attending IMIP, Recife, Brazil. They were randomized to use Mentha piperita or simethicone in the treatment of infantile colic during 7 days with each drug. Primary outcomes were mother_s opinion about responses to the treatment, number of daily episodes of colic, and time spent crying, measured by a chronometer. Mann-Whitney and chi-square tests were used to compare the results. This study was previously approved by the Ethical Committee in Research at IMIP. Results. At baseline daily episodes of infantile colic was 3.9 (±1.1) and the mean crying time per day was 192 minutes (±51.6). At the end of the study daily episodes of colic fell to 1.6 (±0.6) and the crying duration decreased to 111 (±28) minutes. All mothers reported decrease of frequency and duration of the episodes of infantile colic and there were no differences between responses to Mentha piperita and simethicone. Conclusions. These findings suggest that Mentha piperita may be used to help control infantile colic. However, these results must be repeated by others studies.
doi:10.1155/2012/981352
PMCID: PMC3403674  PMID: 22844342
17.  Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study 
Acupuncture in Medicine  2010;24(4):174-179.
Objective
To investigate whether acupuncture reduces the duration and intensity of crying in infants with colic.
Patients and methods
90 otherwise healthy infants, 2–8 weeks old, with infantile colic were randomised in this controlled blind study. 81 completed a structured programme consisting of six visits during 3 weeks to an acupuncture clinic in Sweden. Parents blinded to the allocation of their children met a blinded nurse. The infant was subsequently given to another nurse in a separate room, who handled all infants similarly except that infants allocated to receive acupuncture were given minimal, standardised acupuncture for 2 s in LI4.
Results
There was a difference (p=0.034) favouring the acupuncture group in the time which passed from inclusion until the infant no longer met the criteria for colic. The duration of fussing was lower in the acupuncture group the first (74 vs 129 min; p=0.029) and second week (71 vs 102 min; p=0.047) as well as the duration of colicky crying in the second intervention week (9 vs 13 min; p=0.046) was lower in the acupuncture group. The total duration of fussing, crying and colicky crying (TC) was lower in the acupuncture group during the first (193 vs 225 min; p=0.025) and the second intervention week (164 vs 188 min; p=0.016). The relative difference from baseline throughout the intervention weeks showed differences between groups for fussing in the first week (22 vs 6 min; p=0.028), for colicky crying in the second week (92 vs 73 min; p=0.041) and for TC in the second week (44 vs 29 min; p=0.024), demonstrating favour towards the acupuncture group.
Conclusions
Minimal acupuncture shortened the duration and reduced the intensity of crying in infants with colic. Further research using different acupuncture points, needle techniques and intervals between treatments is required.
doi:10.1136/aim.2010.002394
PMCID: PMC3002757  PMID: 20959312
18.  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
19.  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
20.  Incidence and risk factors for infantile colic in Iranian infants 
AIM: To assess the incidence of infantile colic and its association with variable predictors in infants born in a community maternity hospital, Tehran, Iran.
METHODS: In this prospective cohort study, mothers who gave birth to live newborns between February 21 and March 20, 2003 at the hospital were invited to join to the study. For every infant-mother dyad data were collected on infant gender, type of delivery, gestational age at birth, birth weight, birth order, and mother’s reproductive history. Then mothers were given a diary to document the duration of crying/fussiness behaviors of their infants for the next 12 wk. We scheduled home visits at the time the infants were 3 mo of age to collect the completed diaries and obtain additional information on infants’ nutritional sources and identify if medications were used for colic relief. Cases of colic were identified by applying Wessel criteria to recorded data. Chi-square and Mann-whitney U tests were used to compare proportions for non-parametric and parametric variables, respectively.
RESULTS: From 413 infants, follow-up was completed for 321 infants. In total, 65 infants (20.24%) satisfied the Wessel criteria for infantile colic. No statistical significance was found between colicky and non-colicky infants according to gender, gestational age at birth, birth weight, type of delivery, and, infant’s feeding pattern. However, firstborn infants had higher rate for developing colic (P = 0.03).
CONCLUSION: Colic incidence was 20% in this population of Iranian infants. Except for birth order status, no other variable was significantly associated with infantile colic.
doi:10.3748/wjg.14.4662
PMCID: PMC2738790  PMID: 18698680
Infantile colic; Incidence; Iran; Risk factors
21.  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
22.  Use of sucrose as a treatment for infant colic 
Archives of Disease in Childhood  1997;76(4):356-358.
Accepted 5 November 1996

AIMS—To examine if sucrose has an analgesic effect on infant colic.
METHODS—Nineteen infants with typical infant colic were given 2 ml of 12% sucrose or distilled water when crying, in a double blind double crossover study. The effect was measured by parents' score.
RESULTS—Twelve improved specifically on sucrose and one on placebo (p < 0.01). Five showed a non-specific improvement. 
CONCLUSIONS—Sucrose has a significant ameliorating effect on infant colic.


PMCID: PMC1717160  PMID: 9166032
23.  Higher rectal temperatures in co-sleeping infants. 
Archives of Disease in Childhood  1996;75(3):249-250.
The effect on deep body temperature of infants co-sleeping (with either or both parents) is investigated in this case control study. Overnight continuous recordings of rectal temperature were made from 34 babies co-sleeping with one or both parents throughout the night and 34 infants matched for age, feeding regimen, parental smoking, thermal environment, sleeping position, and sex who slept alone. The co-sleeping infants had significantly higher rectal temperatures from two hours after bedtime, when the initial fall in sleeping body temperature was complete. The mean rectal temperature of co-sleeping infants between two and eight hours was 0.1 degree C higher than that of infants sleeping alone (p < 0.04). Given the very small variance in rectal temperature this probably reflects a considerable physiological difference between the two groups.
PMCID: PMC1511690  PMID: 8976670
24.  Use of Sleep Aids During the First Year of Life 
Pediatrics  2002;109(4):594-601.
Objective.
In an attempt to foster self-soothing during the night, a novel sleep aid infused with maternal odor was introduced to 4 groups of infants ranging in age from 3 to 12 months. Infants’ use of parent-provided sleep aids also was examined.
Methodology.
Nighttime sleep and waking behaviors were videotaped for 2 consecutive nights on 3 occasions over a 3-month interval. Using all-night video recording, the study examined the infant’s use of a novel sleep aid and parent-provided sleep aids during sleep onset and after nighttime awakenings.
Results.
Results indicated that infants of different ages differed in the types of sleep aids used when falling asleep either at the beginning of the night or after awakenings in the middle of the night. More 3-month-olds used their thumbs/fingers/hands, whereas more 6-month-olds used soft objects. The 6-month-olds were most likely to use the novel sleep aid. Almost all of the infants at all 4 ages used some type of object during the night. Intra-individual analyses showed that infants tended to change their pattern of sleep aid use over the 3-month study period.
Conclusions.
The data provide evidence that infants during the first year of life use sleep aids frequently and interchangeably rather than a specific favorite object.
PMCID: PMC1351014  PMID: 11927702
25.  Nighttime sleep-wake patterns and self-soothing from birth to one year of age: a longitudinal intervention study 
Background
The objectives of this study were to: (1) describe the longitudinal development of sleep-wake patterns of solitary-sleeping infants from 1 to 12 months of age, (2) identify effects on sleep patterns and on self-soothing behaviors of introducing a novel sleep aid, and (3) identify predictive factors of self-soothing at 12 months using a transactional model as a guide.
Methods
Eighty infants’ nighttime sleep-wake patterns and associated variables were studied at 5 times across the first year of life using videosomnography and questionnaires.
Results
Sleep-wake state developmental changes, as reported in investigations of infant sleep, were replicated, although a great deal of individual variability in the development of all sleep-related variables was noted. No major effects on sleep or on self-soothing behavior were evident from the introduction of the novel sleep aid. Three variables were identified as significant predictors of self-soothing at 12 months: decreasing amounts of time spent out of crib across the first year, high levels of quiet sleep at birth, and longer parental response times to infant awakenings at 3 months.
Conclusions
These data lend preliminary support for the transactional model and suggest that infant and parental factors interact to influence the development of self-soothing.
PMCID: PMC1201415  PMID: 12236607
Infancy; normal development; parent-child interaction; paediatrics; sleep; temperament; AS: active sleep; AW: wakefulness; BDI: Beck Depression Inventory; GLM: general linear modeling; LSP: longest sleep period; OOC: out of crib; PSOCS: Parenting Sense of Competence Scale; QS: quiet sleep; RSA: representational sleep aid; SC: sham control; SS: self-soothed; TST: total sleep time

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