Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. Use of a behavioural programme in the first 3 months to prevent infant crying and sleeping problems. Stress at three-month immunization: parents' and infants' salivary cortisol response in relation to the use of pacifier and oral glucose. A double-blind randomised controlled trial of 25% oral glucose for pain relief in 2-month old infants undergoing immunisation. An intervention program for families with irritable infants. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Promoting secure attachment, maternal mood and child health in a vulnerable population: a randomized controlled trial. A randomized controlled trial of an early intervention program in low birth weight children: outcome at 2 years.
The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias.
                Infants with unexplained persistent crying (infant colic) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom. Infants younger than 8 weeks were randomized to 1 of 3 groups: (i) infant treated, parent aware; (ii) infant treated, parent unaware; and (iii) infant not treated, parent unaware. The primary outcome was a daily crying diary completed by parents over a period of 10 days. Treatments were pragmatic, individualized to examination findings, and consisted of chiropractic manual therapy of the spine. Analysis of covariance was used to investigate differences between groups.
                One hundred four patients were randomized. In parents blinded to treatment allocation, using 2 or less hours of crying per day to determine a clinically significant improvement in crying time, the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 (adjusted odds ratio [OR], 8.1; 95% confidence interval [CI], 1.4-45.0) and at day 10 (adjusted OR, 11.8; 95% CI, 2.1-68.3). The number needed to treat was 3. In contrast, the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents (adjusted ORs, 0.7 [95% CI, 0.2-2.0] and 0.5 [95% CI, 0.1-1.6] at days 8 and 10, respectively).
                In this study, chiropractic manual therapy improved crying behavior in infants with colic. The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study. Thus, it is unlikely that observed treatment effect is due to bias on the part of the reporting parent.
                Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved. In this open, controlled, prospective study, 28 infants with colic were randomized to either cranial osteopathic manipulation or no treatment; all were seen once weekly for 4 weeks. Treatment was according to individual findings, and administered by the same practitioner. Parents recorded time spent crying, sleeping and being held/rocked on a 24-hour diary. A progressive, highly significant reduction between weeks 1 and 4 in crying (hours/24h) was detected (P<0.001) in treated infants; similarly, there was a significant improvement in time spent sleeping (P<0.002). By contrast, no significant differences were detected in these variables for the control group. Overall decline in crying was 63% and 23%, respectively, for treated and controls; improvement in sleeping was 11% and 2%. Treated infants also required less parental attention than the untreated group. In conclusion, this preliminary study suggests that cranial osteopathic treatment can benefit infants with colic; a larger, double-blind study is warranted. To determine whether there is a short-term effect of spinal manipulation in the treatment of infantile colic.
                A randomized controlled trial.
                A private chiropractic practice and the National Health Service's health visitor nurses in the suburb Ballerup (Copenhagen, Denmark).
                Infants seen by the health visitor nurses, who fulfilled the diagnostic criteria for infantile colic.
                One group received spinal manipulation for 2 weeks, the other was treated with the drug dimethicone for 2 weeks.
                Changes in daily hours of crying as registered in a colic diary.
                By trial days 4 to 7, hours of crying were reduced by 1 hour in the dimethicone group compared with 2.4 hours in the manipulation group (P = .04). On days 8 through 11, crying was reduced by 1 hour for the dimethicone group, whereas crying in the manipulation group was reduced by 2.7 hours (P = .004). From trial day 5 onward the manipulation group did significantly better that the dimethicone group.
                Spinal manipulation is effective in relieving infantile colic. The aim of the study was to evaluate the effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula, each used individually in the treatment of infantile colic.
                The term colic describes a group of symptoms that occur frequently in infants, consisting of paroxysmal abdominal pain and severe crying. Infant colic is of importance for both parents and the community health services that provide families with care, and is therefore an important clinical problem that is amenable to nursing interventions.
                This prospective and randomised-controlled study involved 175 infants in Turkey.
                Data were gathered by using Wessel criteria; parents wrote a daily structured diary, recording the onset and duration of crying. Patients were assigned randomly into four different intervention groups (massage, sucrose solution, herbal tea and hydrolysed formula) and control group. Duration of crying following each intervention was recorded in the diary by parents for a one week period.
                There was a significant reduction in crying hours per day in all intervention groups. The difference between mean duration of total crying (hours/day) before and after the intervention infants in hydrolysed formula group was found higher than massage, sucrose and herbal tea group. The difference between mean duration of total crying(hours/day) before and after the intervention infants in massage group was found lower than other intervention groups and all groups.
                Our findings demonstrated that varied interventions such as administration of massage, sucrose solution, herbal tea and hydrolysed formula are effective in the treatment of colic. The difference between mean duration of total crying (hours/day) before and after the intervention in hydrolysed formula group was found higher than other intervention groups. Hydrolysed formula was the most effective in reducing the duration of crying (hours/day) when compared with the other intervention groups. Massage intervention yielded the least symptomatic improvement among all the interventions.
                Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare settings as an aid to families for the treatment of infantile colic. To assess the effectiveness of a behavioural programme introduced in the first 3 months of age in preventing infant crying and sleeping problems. Two issues were addressed: (i) which elements of the behavioural programme would parents implement; and (ii) whether the behavioural programme was more effective in reducing infant crying and encouraging night-time sleeping than an educational intervention or the routine services.
                Mothers and newborns were assigned at random to the behavioural programme (n = 205), educational intervention (n = 202), or control (n = 203) group. Behaviour diaries kept before randomization and at 3, 6, 9 and 12 weeks of age were used to measure implementation of the interventions and infant behaviour, including crying and sleeping. Crying and sleeping problems were followed up using questionnaire measures at 9 months of age.
                The educational intervention did not change parental care behaviour. One element of the behavioural programme, a focal feed between 10 PM and midnight, was not implemented. A second element, stretching of interfeed intervals after 3 weeks of age, was implemented initially, but not maintained at older ages. The third element, which asked parents to emphasise day and night differences in the environment, and to settle their babies in the cot and minimise interaction at night, was carried out by more parents in the behavioural group than in the other groups. This led to an increase of around 10% in the number of babies who slept for 5 or more hours at night (a definition of sleeping through the night) at 12 weeks of age. Fewer behavioural programme parents sought help for crying and sleeping problems between 3 and 9 months of age.
                The behavioural programme produced a modest increase in the number of infants who slept through the night by 12 weeks of age. The results are discussed in relation to other findings, which bear on the programme's adoption for routine health-care policy and practice. The aims of the present study were to investigate (1) whether the salivary cortisol response could be dampened during a routine three-month immunization if the infant received sweet-tasting solution in combination with a pacifier and (2) stress experienced by parents during immunization of the infant. Ninety-eight infants were included into one of four intervention groups: 'glucose and pacifier', 'water and pacifier', 'glucose', or 'water'. Saliva was collected before and 30 min after the immunization. Infants' crying-time and parents' self-reported stress (VAS) were measured before and after immunization. Infants in the 'pacifier and glucose' group had a significantly smaller change in salivary cortisol than infants in the other groups (F(3,72)=3.1, p<0.05). In the 'glucose and pacifier' group the median salivary cortisol levels decreased 33% after the immunization. In the 'water and pacifier', 'glucose', and 'water' group median cortisol increased with 50%, 42%, and 8%, respectively. No significant differences in crying-time were observed between the intervention groups. If the infant cried before the immunization, the crying-time during the immunization was longer (p<0.01) and cortisol increased more (p<0.05). Median cortisol levels for parents decreased after the immunization (p<0.01). Median VAS increased 50% (p<0.0001) after immunization. First time parents rated higher stress on VAS before immunization (p<0.01). Parents' change in cortisol and VAS were significantly related to infants' crying time. In conclusion, the combination of oral glucose and pacifier dampen infants' salivary cortisol in response to the three-month immunization. Infant immunisation is the most commonly performed health procedure in developed countries. Associated pain may be harmful because we do not know what painful experiences the infant has already had and whether it might contribute to a cumulative pain experience. Healthy infants undergo immunisation with minimal pain relief. However, immunisation pain can be managed using oral sweet solutions.
                To determine the effectiveness of 25% oral glucose solution in reducing immunisation pain in 2-month old infants. TRIAL DESIGN AND METHODS: A double-blind, randomised controlled trial conducted in Jordan. A total of 120 healthy full-term infants who met the eligibility criteria and were attending immunisation clinics for routine 2-month immunisation were randomised to receive either 2 mL of 25% oral glucose solution immediately prior to their immunisation or 2 mL of oral sterile water. Researchers, nurses and parents were blind to the solution. Primary outcome was behavioural pain measured using the Modified Behavioural Pain Scale (MBPS). Secondary outcomes were crying time and duration of full-lung cry. Crying was registered from onset of the immunisation injection and for up to 120 s after completion of the injection procedure.
                Infants in the intervention group experienced statistically and clinically significant reduction in behavioural pain responses (p<0.001), and spent less time crying up to 2 min after the procedure (mean difference 38 vs. 77.9s).
                A 2 mL oral dose of 25% glucose given immediately before an immunisation procedure reduces pain in 2-month old infants.
                Copyright Â© 2011 Elsevier Ltd. All rights reserved. To describe and evaluate a home-based nursing intervention program, the REST routine, which incorporates the use of infant behavior assessment, pattern recognition, individualized infant schedules, specific management strategies, and parent education and support.
                A two-site clinical trial was conducted on 164 healthy full-term infants with excessive unexplained irritability or colic. Infants between the ages of 2 to 6 weeks were randomized to routine care or a home-based intervention program (n = 121). A third group (n = 43) of infants too old at entry for randomization (mean age = 10.4 weeks) were entered into a posttest-only group.
                Infants in the REST routine treatment group cried 1.3 hours per day on average following the intervention program as compared to the control group crying 3 hours per day (p = .02). Infant irritability was resolved (< 1 hour) in 62% of the treatment group while only in 29% of the control group at the time of the 8-week follow-up visit (p = .04).
                Families in both the treatment and control groups reported benefiting from a nurse visiting in their home to inquire about their infant and their well-being. Options for individualizing the program for those most in need of intensive home visiting and other delivery modes for the intervention are areas for further investigation. To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic.
                One hundred infants with typical colicky pain were recruited to a randomised, blinded, placebo controlled clinical trial.
                Nine infants were excluded because inclusion criteria were not met, and five dropped out, leaving 86 who completed the study. There was no significant effect of chiropractic spinal manipulation. Thirty two of 46 infants in the treatment group (69.9%), and 24 of 40 in the control group (60.0%), showed some degree of improvement.
                Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic. This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic. To evaluate the efficacy of an early home-based intervention on the quality of maternal-infant attachment, maternal mood and child health parameters in a cohort of vulnerable families.
                A total of 181 families were recruited to the study in the immediate postnatal period on the basis of a self report questionnaire relating to known family vulnerability factors. Families were assigned randomly to intervention (90), or control (91) groups. The intervention group received a series of home visits from a child health nurse (weekly to 6 weeks, fortnightly to 3 months), with a subgroup receiving home based short-term dynamic therapy from a social worker. Parent/family function was assessed at inception and at 4 months by the Parenting Stress Index and the Edinburgh Post Natal Depression Scale. At 4 months the quality of the home environment was assessed, utilizing the Home Observation for Measurement of the Environment Inventory, as were child and family health parameters and satisfaction with the community child health service.
                At 4 month follow-up, 160 families (80 intervention, 80 control) were available for assessment. The intervention improved family functioning at 4 months. All aspects of the home environment, including the quality of maternal-infant attachment and mothers' relationship with their child, were significantly enhanced. In particular, significant and positive differences were found in parenting with the intervention group feeling less restrictions imposed by the parenting role, greater sense of competence in parenting, greater acceptability of the child, and the child being more likely to provide positive reinforcement to the parent. Early differences in maternal mood were not maintained at 4 months. Various child health parameters were enhanced including immunization status, fewer parent-reported injuries and bruising, and researcher confirmed lack of smoking in the house or around the infant. The families were consistently more satisfied with their community health service.
                This form of early home based intervention targeted to vulnerable families promotes an environment conducive for infant mental and general health and hence long-term psychological and physical well-being, and is highly valued by the families who receive it. Preterm infants are at increased risk of cognitive, motor and behavioral problems. Different intervention programs have been designed in an attempt to improve outcome, but the results are conflicting.
                To examine the effects of an early intervention program on cognitive, motor and behavioral problems and parenting stress among low birth weight children at 2 years corrected age.
                A randomized controlled trial was conducted including infants with a birth weight <2000 g treated at the University Hospital of North Norway, to examine the effects of a modified version of the Mother-Infant Transaction Program on cognitive, motor and behavioral outcomes and parenting stress. The children were assessed with the Bayley Scales of Infant Development and the Child Behavior Checklist/2-3 (CBCL) and the Parenting Stress Index were administered to the parents at 2 years corrected age.
                Sixty-nine children in the intervention group and 67 in the control group were assessed at 2 years. There were no differences between the groups in cognitive or motor outcomes. The intervention group scored consistently lower on all CBCL syndrome scales, but no difference was significant. The mothers in the intervention group reported significantly lower parental stress in both child and parent domain, whereas the fathers reported lower stress in child domain compared to the control group.
                This early intervention program does not improve cognitive, motor or behavioral outcomes at 2 years. There was a significant reduction in parenting stress reported by both mothers and fathers in the intervention group.
The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic.
The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy.
There are inadequate data to reach any definitive conclusions about the safety of these interventions.