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1.  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
2.  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
3.  Before the headache 
Neurology  2012;79(13):1392-1396.
Objective:
Childhood periodic syndromes are thought to be early life expressions of the genetic tendency for migraine. The objective of this study was to determine whether maternal migraine is associated with an increased risk of infant colic, because this may indicate that colic is a childhood periodic syndrome.
Methods:
This was a cross-sectional study performed in general pediatric clinics. To minimize recall bias, mothers were surveyed at their infants' 2-month-old well-child visit, the age when colic is most prevalent. Colic was ascertained via parental report using modified Wessel criteria. Migraine history was obtained by having a physician diagnosis or a positive screen on ID Migraine. The primary outcome measure was difference in colic prevalence in infants with and without a maternal history of migraine.
Results:
Data from 154 infant-mother pairs were analyzed. Infants with a maternal history of migraine were 2.6 times as likely to have colic as infants without a maternal history of migraine (29% vs 11%, prevalence ratio 2.6 (95% confidence interval 1.2−5.5), p = 0.02). There was no difference in the accuracy with which migraineur mothers perceived their infants' colic status compared with that of nonmigraineur mothers. Data on paternal history of migraine were available for 93 infants. Infants with a paternal history of migraine may have a higher prevalence of colic (22% vs 10%), although the prevalence ratio 2.3 (0.6−9.4, p = 0.24) had wide confidence intervals.
Conclusions:
Maternal migraine is associated with increased risk of infant colic. Because migraine has a strong genetic underpinning, this association suggests that colic may be an early life manifestation of migraine.
doi:10.1212/WNL.0b013e31826c1b7b
PMCID: PMC4098946  PMID: 22972642
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.  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
6.  Mothers' postpartum psychological adjustment and infantile colic 
Archives of Disease in Childhood  2006;91(5):417-419.
Background
Infantile colic is a common problem of early infancy. There is limited data on the relation between postpartum maternal psychological problems and colic.
Aim:
To investigate whether infantile colic is associated with postpartum mood disorders or insecure adult attachment style of the mother.
Methods
Seventy eight mothers and newborns were enrolled in this prospective, longitudinal study. Maternal depressive symptoms were screened with Edinburgh Postpartum Depression Score (EPDS) and maternal anxiety was assessed with State‐Trait Anxiety Inventory (STAI). The Adult Attachment Scale was used to determine the attachment style of the mother. Infantile colic was defined according to Wessel criteria.
Results
Infantile colic was present in 17 infants (21.7%); 12.9% of the mothers had an EPDS ⩾13. The mean EPDS of the mothers whose infants had infantile colic (10.2±6.0) was significantly higher than that of the mothers of infants without colic (6.3±4.0). Among infants with infantile colic, 62.5% had mothers who had insecure attachment style, whereas only 31.1% of mothers had insecure attachment when the infant did not have infantile colic.
Conclusion
Postpartum maternal depressive symptoms and insecure attachment style are associated with infantile colic. Screening and early intervention of postpartum depression might promote the health of both the mother and infant.
doi:10.1136/adc.2005.083790
PMCID: PMC2082735  PMID: 16452109
infantile colic; postpartum depression; attachment style
7.  Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial 
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months.
Design Double blind, placebo controlled randomised trial.
Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia.
Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fussing: 85 were randomised to receive probiotic and 82 to receive placebo.
Interventions Oral daily L reuteri (1×108 colony forming units) versus placebo for one month.
Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month. Secondary outcomes were duration of cry or fuss; number of cry or fuss episodes; sleep duration of infant at 7, 14, and 21 days, and 1 and 6 months; maternal mental health (Edinburgh postnatal depression subscale); family functioning (paediatric quality of life inventory), parent quality adjusted life years (assessment of quality of life) at 1 and 6 months; infant functioning (paediatric quality of life inventory) at 6 months; infant faecal microbiota (microbial diversity, colonisation with Escherichia coli), and calprotectin levels at 1 month. In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders.
Results Of 167 infants randomised from August 2011 to August 2012, 127 (76%) were retained to primary outcome; of these, a subset was analysed for faecal microbial diversity, E coli colonisation, and calprotectin levels. Adherence was high. Mean daily cry or fuss time fell steadily in both groups. At 1 month, the probiotic group cried or fussed 49 minutes more than the placebo group (95% confidence interval 8 to 90 minutes, P=0.02); this mainly reflected more fussing, especially for formula fed infants. The groups were similar on all secondary outcomes. No study related adverse events occurred.
Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic. These findings differ from previous smaller trials of selected populations and do not support a general recommendation for the use of probiotics to treat colic in infants.
Trial registration Current Controlled Trials ISRCTN95287767.
doi:10.1136/bmj.g2107
PMCID: PMC3972414  PMID: 24690625
8.  Colic in infants 
Clinical Evidence  2010;2010:0309.
Introduction
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).
Results
We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: 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
9.  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
10.  Gastrointestinal symptoms of infantile colic and their change after light needling of acupuncture: a case series study of 913 infants 
Chinese Medicine  2011;6:28.
Background
Infantile colic is a common painful clinical condition associated with signs of distended intestines and an increase in colon peristalsis. However, clinical documentation of observed gastrointestinal functions in the condition is still lacking. Even though the ailment is common, no clear treatment guidelines exist. While acupuncture with minimal stimulation has been shown to be effective in reducing crying behaviour of infants suffering from colic, the documented effect of acupuncture on gastrointestinal function in children with infantile colic is scarce. This case series study aims to document the symptoms of routinely rated gastrointestinal function and the changes in these symptoms after minimal acupuncture in a larger group of children with infantile colic.
Methods
This study included 913 infants with normal weights, and lengths at birth. The infants' mean age was 5.4 weeks when the observations started, and had colic symptoms since two weeks after birth. Light needling stimulation of the acupuncture point LI4 was performed for 10-20 seconds bilaterally on a daily basis for a mean of 6.2 consecutive days. A questionnaire with verbal rating scales for the parents' evaluation was used before and after the treatment period.
Results
Before treatment the infants were assessed by the parents in terms of 'often have inflated stomachs' (99%) and 'seldom drool' (76%), 'regurgitate' (53%) and 'belch' (62%). Moreover, the reported frequency of defecation was 5-8 times per day (64%), with a yellowish-green colour (61%) and with a water-thin consistency (74%). After treatment, the variables of inflated stomachs, drooling and regurgitating were systematically changed, and rated by the parents as occurring 'sometimes' while belching was rated as occurring 'often' and the frequency of defecation was reduced to 1-4 times/day with a mustard yellow colour and a gruel-like consistency. The parents also rated their impression of the infants' general colic symptoms including crying behaviour as much ameliorated in 76% of the cases.
Conclusion
The results of the present study show that minimal acupuncture at LI4 in infantile colic is an effective and easy treatment procedure that, furthermore, is reported to be without serious side effects.
doi:10.1186/1749-8546-6-28
PMCID: PMC3162946  PMID: 21835014
11.  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
12.  Prenatal drug exposure and maternal and infant feeding behaviour 
Objective: To evaluate feeding difficulties and maternal behaviour during a feeding session with 1 month old infants prenatally exposed to cocaine and/or opiates.
Methods: The study is part of the maternal lifestyle study, which recruited 11 811 subjects at four urban hospitals, then followed 1388 from 1 to 36 months of age. Exposure to cocaine and opiates was determined by maternal interview and meconium assay. At the 1 month clinic visit, biological mothers were videotaped while bottle feeding their infants. This sample included 364 exposed to cocaine, 45 exposed to opiates, 31 exposed to both drugs, and 588 matched comparison infants. Mothers were mostly black, high school educated, and on public assistance. Videotapes were coded without knowledge of exposure status for frequency, duration and quality of infant sucking, arousal, feeding problems, and maternal feeding activity and interaction.
Results: No cocaine effects were found on infant feeding measures, but cocaine-using mothers were less flexible (6.29 v 6.50), less engaged (5.77 v 6.22), and had shorter feeding sessions (638 v 683 seconds). Opiate exposed infants showed prolonged sucking bursts (29 v 20 seconds), fewer pauses (1.6 v 2.2 per minute), more feeding problems (0.55 v 0.38), and increased arousal (2.59 v 2.39). Their mothers showed increased activity (30 v 22), independent of their infants' feeding problems.
Conclusions: Previous concerns about feeding behaviour in cocaine exposed infants may reflect the quality of the feeding interaction rather than infant feeding problems related to prenatal exposure. However, opiate exposed infants and their mothers both contributed to increased arousal and heightened feeding behaviour.
doi:10.1136/fn.88.5.F391
PMCID: PMC1721596  PMID: 12937043
13.  Self-medication for infants with colic in Lagos, Nigeria 
BMC Pediatrics  2009;9:9.
Background
Infantile colic is a self-limiting condition that is distributed worldwide. It is often misdiagnosed as an organic disease for which an infant is admitted to the hospital. Many studies have described the aetiopathogenesis, pharmacologic and non-pharmacologic management of colic but none has evaluated self-medication for infants with colic. The aim of this study was therefore to determine the knowledge of Nigerian mothers about colic, their home-based management, extent of self-medication for the infants with colic and the types of medicines involved.
Methods
It is a prospective study conducted at the vaccination clinics of 20 primary health care centres, each from different Local Government Areas in Lagos, Nigeria. Eight hundred mothers that brought their infants for vaccination between April and September, 2006 were interviewed with open-and close-ended questionnaire.
Results
Six hundred and eighty three (85.4%) mothers claimed they had a good knowledge of colic. Incessant and excessive cry was the main clinical feature of colic identified by 430(62.9%) mothers. Three hundred and seventy eight (67.7%) infants were treated by self-medication, 157 (28.1%) sought medical intervention and 17 (3.1%) were treated at a traditional birth attendant home. Herbal medicines constituted 51.8% of the self-medicated medicines, of which 48 (26.2%) were "Ororo Ogiri". Nospamin® (49.5%) and Gripe water® (43.0%) were the two frequently prescribed and self-medicated medicines for infants with colic.
Conclusion
Nigerian mothers are deficient in their knowledge of colic. Self-medication was the most frequently used home-based intervention. Health education would appear necessary to improve parental management of this self-limiting condition.
doi:10.1186/1471-2431-9-9
PMCID: PMC2645392  PMID: 19193235
14.  Epidemiology of impaction colic in donkeys in the UK 
Background
Colic (abdominal pain) is a clinical condition of serious concern affecting the welfare and survival of donkeys at the Donkey Sanctuary in the UK. One of the most commonly reported causes is due to impacted ingesta in the large intestine ("impaction colic"). However little is known about the incidence of, or risk factors for, this condition. Here we describe the epidemiology of colic in donkeys, specifically impaction colic. We focus on temporal aspects of the disease and we identify environmental and management related risk factors for impaction colic in UK donkeys.
Results
There were 807 colic episodes in the population of 4596 donkeys between January 1st 2000 and March 31st 2005. The majority (54.8%) of episodes were due to a suspected or confirmed diagnosis of impaction of the gastrointestinal tract. The mortality risk for all colics (51.1%) was higher than reported in other equids. The incidence rate of all colics (5.9 episodes per 100 donkeys per year) and of impaction colic (3.2 episodes) was similar to that in horses. A retrospective matched case-control study of all impaction colics from January 2003 (193) indicated that older donkeys, those fed extra rations and those that previously suffered colic were at increased risk of impaction. Lighter body weight, musculo-skeletal problems, farm and dental disease were also significantly associated with a diagnosis of impaction colic.
Conclusion
To our knowledge this is the first study to estimate the incidence rate of colic in a large population of donkeys in the UK. In contrast to other equids, impaction was the most commonly reported cause of colic. We identified several risk factors for impaction colic. Increasing age, extra rations and previous colic are known risk factors for colic in other equids. Results support the hypothesis that dental disease is associated with impaction colic. Musculo-skeletal problems may be associated with colic for various reasons including change in amount of exercise or time at pasture. Other associated factors (weight and farm) are the subject of further research. Identification of risk factors for impaction colic may highlight high risk donkeys and may allow intervention strategies to be introduced to reduce the incidence of the disease.
doi:10.1186/1746-6148-3-1
PMCID: PMC1800892  PMID: 17274808
15.  GORD in children 
Clinical Evidence  2008;2008:0310.
Introduction
Gastro-oesophageal regurgitation is considered a problem if it is frequent, persistent, and associated with other symptoms such as increased crying, discomfort with regurgitation, and frequent back arching. A cross-sectional survey of parents of 948 infants attending 19 primary care paediatric practices found that regurgitation of at least one episode a day was reported in 51% of infants aged 0 to 3 months.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatment for symptomatic gastro-oesophageal reflux? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: domperidone, feed thickeners in infants, H2 antagonists, head elevated sleep positioning, left lateral or prone sleep positioning, metoclopramide, proton pump inhibitors, sodium alginate, surgery, soy formula with added fibre, and weight loss.
Key Points
Reflux of gastric contents into the oesophagus in children causes recurrent vomiting (usually before 6 weeks of age), epigastric and abdominal pain, feeding difficulties, failure to thrive, and irritability. At least half of infants regurgitate feeds at least once a day, but this only causes other problems in about 20% of infants, and most cases resolve spontaneously by 12 to 18 months of age.Risk factors include lower oesophageal sphincter disorders, hiatus hernia, gastric distension, raised intra-abdominal pressure, and neurodevelopmental problems.
Sleeping in the left lateral or prone position may improve oesophageal pH compared with sleeping supine or on the right side, but these positions may increase the risk of SIDS compared with supine sleeping, and their effect on clinically important outcomes is unknown. We don't know whether sleeping in the prone elevated position reduces symptoms compared with the prone horizontal position, or whether weight loss reduces symptoms.
Thickened feeds may reduce the severity and frequency of regurgitation in the short term.
Sodium alginate may reduce the frequency of regurgitation compared with placebo, although studies have given conflicting results. The high sodium content of sodium alginate may make it unsuitable for use in preterm babies.
Metoclopramide may be effective, but studies have given conflicting results and it can cause adverse effects.
We don't know whether domperidone, H2 antagonists, proton pump inhibitors, or surgery reduce symptoms in babies with gastro-oesophageal reflux, and they may cause adverse effects.
Soy-based formula with added fibre may reduce the frequency of regurgitation in infants in the neonatal period compared with cow’s milk infant formulas.
PMCID: PMC2907988  PMID: 19445794
16.  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
17.  Fetal growth and infantile colic 
AIM—To describe how fetal growth and gestational age affect infantile colic, while considering other potential risk factors.
STUDY DESIGN—A population based follow up study of 2035 healthy singleton infants without any disability born to Danish mothers. Information was collected by self administered questionnaires at 16 and 30weeks of gestation, at delivery, and 8 months post partum. Infantile colic is defined according to Wessel's criteria, but symptoms are restricted to crying for more than three hours a day, for more than three days a week, and for more than three weeks.
RESULTS—The cumulated incidence of infantile colic was 10.9%. Low birth weight babies (< 2500 g) had more than twice the risk (odds ratio = 2.7, 95% confidence interval 1.2 to 6.1) of infantile colic when controlled for gestational age, maternal height, and smoking.
CONCLUSION—Low birth weight may be associated with infantile colic, and further research will be aimed to focus on fetal growth and infantile colic.


doi:10.1136/fn.83.1.F44
PMCID: PMC1721113  PMID: 10873171
18.  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
19.  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
20.  The social origins of infantile colic: questionnaire study covering 76,747 infants. 
BMJ : British Medical Journal  1997;314(7090):1325-1328.
OBJECTIVE: To describe risk factors for infantile colic. DESIGN: Questionnaire administered by health visitors. SETTING: Sheffield. SUBJECTS: Mothers of 76,747 infants born between 1 August 1975 and 31 May 1988, interviewed when the infant was 1 month old. MAIN OUTCOME MEASURES: Reporting of infantile colic and its duration; weight of infant leeding, state of the home, socioeconomic characteristics of the parents, parents' age, and mother's parity. RESULTS: The odds of reporting infantile colic were increased with breast feeding (odds ratio of breast v bottle feeding 1.35 (95% confidence interval 1.28 to 1.43)), increasing parental age, lower parity, increasing parental age at leaving full time education, and more affluent homes and districts of residence. In a logistic regression analysis, mother's age and parity and socioeconomic factors remained the most important risk factors for the reporting of infantile colic (each P < 0.005), and the effect of breast feeding was attenuated (odds ratio of breast v bottle feeding 1.09 (1.02 to 1.15)). CONCLUSION: At a population level, dietary factors contribute little to mothers' reporting of infantile colic, and dietary change should not be the primary intervention.
PMCID: PMC2126574  PMID: 9158470
21.  Chest physiotherapy, gastro-oesophageal reflux, and arousal in infants with cystic fibrosis 
Archives of Disease in Childhood  2004;89(5):435-439.
Background: Postural drainage chest physiotherapy in infants with cystic fibrosis (CF) exacerbates gastro-oesophageal reflux (GOR) and may contribute to a more rapid deterioration in lung function.
Aims: To compare standard postural drainage chest physiotherapy (SPT) and a modified physiotherapy regimen (MPT) without head-down tilt, with regard to GOR, arousal state, and cardiorespiratory function.
Methods: Twenty infants with CF underwent 30 hour oesophageal pH monitoring, during which four chest physiotherapy sessions were administered (day 1: MPT–SPT; day 2: SPT–MPT). Arousal state, heart rate, and oxygen saturation were documented for each of the physiotherapy positions (supine, prone, right lateral, and left lateral with (SPT) or without (MPT) 30° head-down tilt).
Results: Significantly more reflux episodes occurred during SPT than during MPT, but there were no significant differences in median episode duration or fractional reflux time. During SPT, left lateral positioning was associated with fewer reflux episodes compared to other positions. During supine and prone positioning, more reflux episodes occurred during SPT than during MPT. Infants were significantly more likely to be awake or cry during SPT. There was a significant association between crying and reflux episodes for SPT. Non-nutritive sucking was associated with a significant reduction in reflux episodes during SPT. Oxygen saturation during SPT was significantly lower during crying and other waking, and non-nutritive sucking during SPT was associated with a significant increase in oxygen saturation.
Conclusions: SPT is associated with GOR, distressed behaviour, and lower oxygen saturation.
doi:10.1136/adc.2003.033100
PMCID: PMC1719900  PMID: 15102635
22.  Looking for new treatments of Infantile Colic 
Infantile colic is a common disturbance occurring in the first three months of life. It is a benign condition and one of the main causes of pediatric consultation in the early part of life because of its great impact on family life. Some pediatricians are prone to undervalue this issue mainly because of the lack of evidence based medicine guidelines. Up to now, there is no consensus concerning management and treatment. Literature reports growing evidence about the effectiveness of dietary, pharmacological, complementary and behavioral therapies as options for the management of infantile colic. Dietary approach, usually based on the avoidance of cow’s milk proteins in breast-feeding mothers and bottle-fed infants, more recently has seen the rise of new special formulas, such as partially hydrolyzed proteins and low lactose added with prebiotics or probiotics: their efficacy needs to be further documented. Investigated pharmacological agents are Simethicone and Cimetropium Bromide: the first is able to reduce bloating while the second could reduce fussing crying, but it has been tested only for severe infantile colic. No other pain relieving agents have been proposed until now, but some clinical trials are ongoing for new drugs.
There is limited evidence supporting the use of complementary and alternative treatments (herbal supplements, manipulative approach and acupuncture) or behavioral interventions.
Recent studies have focused the role of microbiota in the pathogenesis of this disturb and so new treatments, such as probiotics, have been proposed, but only few strains have been tested.
Further investigations are needed in order to provide evidence-based guidelines.
doi:10.1186/1824-7288-40-53
PMCID: PMC4050441  PMID: 24898541
23.  The influence of eating disorders on mothers’ sensitivity and adaptation during feeding: a longitudinal observational study 
Background
Parents with past and current eating disorders (ED) have been shown to report troubles nourishing their infants. This could increase the risk of infant feeding problems linked to maternal anxiety and depression. It is not clear how mothers’ eating difficulties before pregnancy and at the time of birth can affect infant’s feeding. We aimed to specify the impact of eating disorders on mothers’ adaptation and sensitivity to their offspring during feeding, by comparing a population of mothers with eating disorders and controls.
Methods
Twenty-eight women agreed to participate in interviews and filmed mother-baby interactions. Pregnant women consulting at an obstetric unit for care follow-up were screened and tested for symptoms of eating disorders with the EDE-Q Questionnaire (Eating Disorders Examination Questionnaire) and the EDE Interview (Eating Disorders Examination Interview). Infant functional troubles and mothers’ sensitivity were investigated through the Symptom Check List. Reciprocal adaptation during feeding with their new-borns was filmed and analysed with the Chatoor Infant Feeding Scale. Before pregnancy, two women suffered from anorexia, three suffered from bulimia, three had binge eating symptoms and two were diagnosed with EDNOS (Eating Disorders Not Otherwise Specified).
Results
Mothers suffering from ED tended to show more difficult interactive patterns in terms of dyadic reciprocity when feeding their babies compared with mothers with no symptoms of eating disorders. In the interviews, other than the behavioural data gathered, ED mothers expressed feeling more dissatisfaction and uneasiness during feeding.
Conclusions
Pregnancy seems to be an useful period for interviewing women on eating disorders, allowing for the design and implementation of prevention programmes based on mothers’ narratives and infant/mother observations and treatment.
doi:10.1186/1471-2393-14-274
PMCID: PMC4138399  PMID: 25123354
Eating disorders; Pregnancy; Eating disorder questionnaire; Symptom Check-List; Mother-infant feeding scale; Maternal sensitivity
24.  Psychosocial predisposing factors for infantile colic. 
BMJ : British Medical Journal  1993;307(6904):600-604.
OBJECTIVE--To study associations between characteristics of families during the first pregnancy and after childbirth and the development of infantile colic. DESIGN--Randomised, stratified cluster sampling. Follow up from the first visit to a maternity health care clinic during pregnancy to three months after birth with confidential semistructured questionnaires. SETTING--Maternity health care clinics in primary health care centres in Finland. SUBJECTS--1443 nulliparous women and 1407 partners. Altogether 1333 women and 1279 men returned the questionnaires. When the infants were 3 months old 1208 women and 1115 men returned questionnaires. MAIN OUTCOME MEASURES--Marital relationship; personal and social behaviour of parents during the pregnancy and their coping with the pregnancy; mothers' physical health and events, symptoms, and experiences in relation to pregnancy; self confidence and experiences of mothers and fathers in relation to childbirth; and parents' sociodemographic and educational variables. Measure of colic when the infant was 3 months old. RESULTS--Experience of stress and physical symptoms during the pregnancy, dissatisfaction with the sexual relationship, and negative experiences during childbirth were associated with the development of colic in the baby. None of the sociodemographic factors was associated with colic. CONCLUSIONS--Early preventive health work during pregnancy should attempt to improve parents' tolerance of symptoms of stress and ability to cope and increase their confidence in parenting abilities.
PMCID: PMC1678925  PMID: 8401016
25.  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

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