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.
Background: Infants with neonatal cerebral insults are susceptible to excessive crying as a result of difficulties with self-regulation.
Aims: To compare the effectiveness of swaddling versus massage therapy in the management of excessive crying of infants with cerebral insults.
Methods: Randomised three-week parallel comparison of the efficacy of two intervention methods. Infants with symptoms of troublesome crying and their parents were randomly assigned to a swaddling intervention group (n = 13) or a massage intervention group (n = 12).
Results: The amount of total daily crying decreased significantly in the swaddling group, but did not decrease significantly in the massage group. Infant behavioural profiles and maternal anxiety levels improved significantly in the swaddling group post-intervention. Parents in the swaddling group were more satisfied with the effectiveness of the intervention in reducing crying than parents in the massage group.
Conclusion: Results indicate that swaddling may be more effective than massage intervention in reducing crying in infants with cerebral injuries.
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.
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.
Colic; Crying; Infant; Baby
Shaken baby syndrome often occurs after shaking in response to crying bouts. We questioned whether the use of the educational materials from the Period of PURPLE Crying program would change maternal knowledge and behaviour related to shaking.
We performed a randomized controlled trial in which 1279 mothers received materials from the Period of PURPLE Crying program or control materials during a home visit by a nurse by 2 weeks after the birth of their child. At 5 weeks, the mothers completed a diary to record their behaviour and their infants' behaviour. Two months after giving birth, the mothers completed a telephone survey to assess their knowledge and behaviour.
The mean score (range 0–100 points) for knowledge about infant crying was greater among mothers who received the PURPLE materials (63.8 points) than among mothers who received the control materials (58.4 points) (difference 5.4 points, 95% confidence interval [CI] 4.1 to 6.5 points). The mean scores were similar for both groups for shaking knowledge and reported maternal responses to crying, inconsolable crying and self-talk responses. Compared with mothers who received control materials, mothers who received the PURPLE materials reported sharing information about walking away if frustrated more often (51.5% v. 38.5%, difference 13.0%, 95% CI 6.9% to 19.2%), the dangers of shaking (49.3% v. 36.4%, difference 12.9%, 95% CI 6.8% to 19.0%), and infant crying (67.6% v. 60.0%, difference 7.6%, 95% CI 1.7% to 13.5%). Walking away during inconsolable crying was significantly higher among mothers who received the PURPLE materials than among those who received control materials (0.067 v. 0.039 events per day, rate ratio 1.7, 95% CI 1.1 to 2.6).
The receipt of the Period of PURPLE Crying materials led to higher maternal scores for knowledge about infant crying and for some behaviours considered to be important for the prevention of shaking. (ClinicalTrials.gov trial register no. NCT00175422.)
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
AIM: To evaluate the impact of feeding colicky infants with an adapted formula on the hydrogen breath test and clinical symptoms.
METHODS: Hydrogen expiration was measured by SC MicroLyzer gas chromatography at inclusion and 15 d after treatment with an adapted low-lactose formula in 20 colicky infants.
RESULTS: All babies were symptomatic: 85% with excess gas, 75% with abnormal feeding pattern, and 85% with excessive crying. The hydrogen breath test at inclusion was abnormal: 35 ± 3.1 ppm. After 15 d feeding with an adapted low-lactose formula, crying and flatulence decreased in 85% of patients (P < 0.001). For infants in whom no decrease of gas was reported, crying was still reduced (P < 0.01). Moreover, the feeding pattern was improved in 50% of infants when it was initially considered as abnormal. Finally, the hydrogen breath test decreased significantly (10 ± 2.5 ppm, P < 0.01).
CONCLUSION: This study showed an association between clinical improvement and evidence of decreased levels of hydrogen when the infants were fed with a specially designed, low-lactose formula.
Infants; Colic; Lactose; Hydrogen breath test
Infants who cry a lot, or are unsettled in the night, are common sources of concern for parents and costly problems for health services. The two types of problems have been linked together and attributed to a general disturbance of infant regulation. Yet the infant behaviours involved present differently, at separate ages and times of day. To clarify causation, this study aims to assess whether prolonged crying at 5–6 weeks (the peak age for crying) predicts which infants are unsettled in the night at 12 weeks of age (when most infants become settled at night).
Data from two longitudinal studies are analysed. Infant crying data were obtained from validated behaviour diaries; sleep-waking data from standard parental questionnaires.
A significant, weak relationship was found between crying at 5–6 weeks and 12-week night waking and signalling in one study, but not the other. Most infants who met the definition for prolonged crying/colic at 5–6 weeks were settled during the night at 12 weeks of age; they were not more likely than other infants to be unsettled.
Most infants who cry a lot at 5–6 weeks of age ‘sleep through the night’ at 12 weeks of age. This adds to evidence that the two types of problematic behaviour have different causes, and that infant sleep-waking problems usually involve maintenance of signalling behaviours rather than a generalised disturbance.
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.
With an increase in the prevalence of overweight being seen as early as infancy, it is essential that the factors which account for early excess weight gain be identified. In this study, maternal and infant characteristics were examined to determine their relation to the frequency of infants being fed. A cohort of 67 low-educated Mexican mothers who formula-fed their infants were recruited at a WIC Center and home-visited when their infants were 6-months-old. Mothers were surveyed with regard to their feeding attitudes and perception of their infant’s temperament, and kept a 24-hour diary of their infant’s behavior. Nearly 30% of the 6-month-old infants were at or above the 85th percentile of weight-for length. A regression analysis revealed only one factor, the number of infant crying episodes, as predictive of infant feeding (Beta = .246, p<.07), with the correlation even stronger (r =.35 (p<.01). As crying appeared to elicit feeding among these mothers, pediatricians, nurses, and WIC educators should consider discussing alternate strategies for quieting infants with the mothers they counsel.
Infant feeding; temperament; Mexican mothers
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.
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.
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.
Babies with excessive crying should not be viewed as a homogenous group. Treatment outcomes may be improved by targeting appropriate subgroups prior to treatment.
Subgroups; infant colic; excessive crying of infancy; Sous-groupes; colique du nourrisson; pleurs excessifs du nourrisson
Sweating from the palm and sole occurs independently of ambient temperature but is influenced by emotional factors. It thus provides a useful objective measure of emotional state. The development of this emotional sweating in the newborn was investigated by measuring palmar water loss and relating it to the infant's state of arousal. Although 433 individual measurements were made on 124 babies of gestational age 25 to 41 weeks and postnatal age 15 hours to 9 weeks. Palmar water loss was also recorded continuously in 22 infants undergoing heel prick for routine blood sampling. In babies of 37 weeks' gestation or more, there was a clear relationship between palmar water loss and arousal from the day of birth, and by the third week levels on vigorous crying were comparable with those of an anxious adult. Less mature babies did not show emotional sweating at birth; it was first seen at the equivalent of 36 to 37 weeks' gestation regardless of maturity. Continuous recordings confirmed the cross-sectional data and illustrated the abrupt nature of the response. Emotional sweating could be a useful tool for the assessment of emotional state of the newborn.
Origins of mothers’ and fathers’ beliefs about infant crying were examined in 87 couples. Parents completed measures of emotion minimization in the family of origin, depressive symptoms, empathy, trait anger, and coping styles prenatally. At 6 months postpartum, parents completed a self-report measure of their beliefs about infant crying. Mothers endorsed more infant-oriented and less parent-oriented beliefs about crying than did fathers. Consistent with prediction, a history of emotion minimization was linked with more parent-oriented and fewer infant-oriented beliefs about infant crying for both mothers and fathers either as a main effect or in conjunction with the partners’ infant-oriented beliefs. Contrary to expectation, parents’ own emotional dispositions had little effect on parents’ beliefs about crying. The pattern of associations varied for mothers and fathers in a number of ways. Implications for future research and programs promoting sensitive parenting are discussed.
Parental beliefs; infants; crying; family of origin; parental sensitivity
The potential of sucrose to reduce the pain response in a group of healthy premature infants was investigated. Fifteen infants of 32-34 weeks postmenstrual age were tested in a blind crossover manner on two separate occasions no more than two days apart. Either 1 ml of 25% sucrose solution or sterile water was syringed into the baby's mouth 2 minutes before routine heel lancing. Response to the painful stimuli was measured by duration of cry and by facial expression (pain score). There was a significant reduction in the duration of first cry, the percentage of time spent crying in the 5 minutes after heel prick, and the pain score in the sucrose treated group. It is concluded that sucrose has analgesic effects in healthy premature infants.
This study investigated depression-related differences in primiparous mothers’ neural response to their own infant’s distress cues. Mothers diagnosed with major depressive disorder (n = 11) and comparison mothers with no diagnosable psychopathology (n = 11) were exposed to their own 18-months-old infant’s cry sound, as well as unfamiliar infant’s cry and control sound, during functional neuroimaging. Depressed mothers’ response to own infant cry greater than other sounds was compared to non-depressed mothers’ response in the whole brain [false discovery rate (FDR) corrected]. A continuous measure of self-reported depressive symptoms (CESD) was also tested as a predictor of maternal response. Non-depressed mothers activated to their own infant’s cry greater than control sound in a distributed network of para/limbic and prefrontal regions, whereas depressed mothers as a group failed to show activation. Non-depressed compared to depressed mothers showed significantly greater striatal (caudate, nucleus accumbens) and medial thalamic activation. Additionally, mothers with lower depressive symptoms activated more strongly in left orbitofrontal, dorsal anterior cingulate and medial superior frontal regions. Non-depressed compared to depressed mothers activated uniquely to own infant greater than other infant cry in occipital fusiform areas. Disturbance of these neural networks involved in emotional response and regulation may help to explain parenting deficits in depressed mothers.
depression; fMRI; mother; infant; cry
This study examined differences in acoustic characteristics of infant cries in a sample of babies at risk for autism and a low-risk comparison group. Cry samples derived from vocal recordings of 6-month-old infants at risk for autism spectrum disorder (ASD; n = 21) and low-risk infants (n = 18) were subjected to acoustic analyses using analysis software designed for this purpose. Cries were categorized as either pain-related or non-pain-related based on videotape coding. At-risk infants produced pain-related cries with higher and more variable fundamental frequency (F0) than low-risk infants. At-risk infants later classified with ASD at 36 months had among the highest F0 values for both types of cries and produced cries that were more poorly phonated than those of nonautistic infants, reflecting cries that were less likely to be produced in a voiced mode. These results provide preliminary evidence that disruptions in cry acoustics may be part of an atypical vocal signature of autism in early life.
autism; infancy; cry; vocalizations; acoustic analysis
Crying is a universal vocalization in human infants, as well as in the infants of other mammals. Little is known about the neural structures underlying cry production, or the circuitry that mediates a caregiver’s response to cry sounds. In this review, the specific structures known or suspected to be involved in this circuit are identified, along with neurochemical systems and hormones for which evidence suggests a role in responding to infants and infant cries. In addition, evidence that crying elicits parental responses in different mammals is presented. An argument is made for including ‘crying’ as a functional category in the vocal repertoire of all mammalian infants (and the adults of some species). The prevailing neural model for crying production considers forebrain structures to be dispensable. However, evidence for the anterior cingulate gyrus in cry production, and this structure along with the amygdala and some other forebrain areas in responding to cries is presented.
mammals; vocalization; behavior; brain; evolution
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.
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.
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.
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.
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.
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.
This study used fMRI to measure brain activity during adult processing of cries of infants with autistic disorder (AD) compared to cries of typically developing (TD) infants. Using whole brain analysis, we found that cries of infants with AD compared to those of TD infants elicited enhanced activity in brain regions associated with verbal and prosodic processing, perhaps because altered acoustic patterns of AD cries render them especially difficult to interpret, and increased activity in brain regions associated with emotional processing, indicating that AD cries also elicit more negative feelings and may be perceived as more aversive and/or arousing. Perceived distress engendered by AD cries related to increased activation in brain regions associated with emotional processing. This study supports the hypothesis that cry is an early and meaningful anomaly displayed by children with AD. It could be that cries associated with AD alter parent-child interactions much earlier than the time that reliable AD diagnosis normally occurs.
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.
The aims of this study were (1) to confirm gender differences in crying in middle childhood and (2) to identify factors that may explain why girls cry more than boys in a Dutch sample (North Holland and Utrecht). We examined 186 children’s (age: 9–13 years) self-reports on crying, catharsis, seeking support for feelings, and internalizing feelings. Girls reported a greater crying frequency and crying proneness, and more emotional and physical catharsis after crying. In addition, they more frequently sought support for feelings and more often experienced sadness and somatic complaints than boys. Seeking help for negative feelings and the experience of sadness and somatic complaints were positively associated with crying frequency and crying proneness. Emotional catharsis was positively linked to crying proneness. Support was found for the potential mediating role of sadness and somatic complaints with respect to the gender difference in crying frequency and for the potential mediating role of emotional catharsis and somatic complaints for crying proneness. This study demonstrates that gender differences in crying frequency already exist in middle childhood and the findings suggest a linkage between these gender differences in crying and psychosocial factors.
Tears; Crying; Children; Emotion expression; Gender; Development
Infant colic, characterised by excessive crying/fussing for no apparent cause, affects up to 20% of infants under three months of age and is a great burden to families, health professionals and the health system. One promising approach to improving its management is the use of oral probiotics. The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old (<13.0 weeks) with infant colic when compared to placebo.
Design: Double-blind, placebo-controlled randomised trial in Melbourne, Australia. Participants: 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel’s criteria of crying and/or fussing. Intervention: Oral once-daily Lactobacillus reuteri (1x108 cfu) versus placebo for one month. Primary outcome: Infant crying/fussing time per 24 hours at one month. Secondary outcomes: i) number of episodes of infant crying/fussing per 24 hours and ii) infant sleep duration per 24 hours (at 7, 14, 21, 28 days and 6 months); iii) maternal mental health scores, iv) family functioning scores, v) parent quality adjusted life years scores, and vi) intervention cost-effectiveness (at one and six months); and vii) infant faecal microbiota diversity, viii) infant faecal calprotectin levels and ix) Eschericia coli load (at one month only). Analysis: Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data. Regression models will be used to adjust for potential confounding factors. Intention-to-treat analysis will be applied.
An effective, practical and acceptable intervention for infant colic would represent a major clinical advance. Because our trial includes breast and formula-fed babies, our results should generalise to most babies with colic. If cost-effective, the intervention’s simplicity is such that it could be widely taken up as a new standard of care in the primary and secondary care sectors.
Current Controlled Trials ISRCTN95287767
Colic; Crying; Infant; Probiotics; Randomised controlled trial; Health care costs; Postpartum depression; Mental health; Quality of life; Biota
We have evaluated the binding of Bacillus thuringiensis Cry toxins to aminopeptidase N (APN) purified from Lymantria dispar (gypsy moth) brush border membrane vesicle (BBMV). CryIAc toxin bound strongly to APN, while either the structurally related CryIAa and CryIAb toxins or CryIC, CryIIA, and CryIIIA toxins showed weak binding to APN. An in vitro competition binding study demonstrated that the binding of CryIAc to L. dispar BBMV was inhibited by APN. Inhibition of short circuit current for CryIAc, measured by voltage clamping of whole L. dispar midgut, was substantially reduced by addition of phosphatidylinositol-specific phospholipase C, which is known to release APN from the midgut membrane. In contrast, addition of phosphatidylinositol-specific phospholipase C had only a marginal effect on the inhibition of short circuit current for CryIAa. These data suggest that APN is the major functional receptor for CryIAc in L. dispar BBMV. A ligand blotting experiment demonstrated that CryIAc recognized a 120-kDa peptide (APN), while CryIAa and CryIAb recognized a 210-kDa molecule in L. dispar BBMV. In contrast, CryIAa and CryIAb bound to both the 120- and 210-kDa molecules in Manduca sexta BBMV, while CryIAc recognized only the 120-kDa peptide. The 120-kDa peptide (APN) in L. dispar BBMV reacted with soybean agglutinin, indicating that N-acetylgalactosamine is a component of this glycoprotein.