Efficacy of chiropractic manual therapy on infant colic: a pragmatic single-blind, randomized controlled trial. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. 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. An intervention program for families with irritable infants. Randomised controlled trial of biofeedback training in persistent encopresis with anismus. Use of a behavioural programme in the first 3 months to prevent infant crying and sleeping problems. Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting. The effects of various interventions to newborns on pain and duration of crying.
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. 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. 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. 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. Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction.
                A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up.
                Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, -24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, -46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, -75% to -1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different between the BFT and control groups, but there was a significant improvement in CBCL school scale scores in the BFT group, and this improvement was significantly greater than that seen in the control group.
                The result of this study, together with those reported in other controlled trials, argues against using biofeedback training in children with encopresis. 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 objective was to study the generalizability of trial results by comparing randomized patients to eligible but nonrandomized patients who received the same management. Implementation of trial results is only justifiable when the results can be generalized to the total domain population. The design was a multicentre randomized controlled trial on the effect of early screening and treatment with ventilation tubes on infants with otitis media with effusion. Randomized (n = 187) and nonrandomized eligible patients (n = 133) were followed up. The study population comprised children who were detected by auditory screening at the age of 9-12 months and who were subsequently diagnosed with persistent bilateral otitis media with effusion for 4-6 months. A significant difference was found in the distribution of some prognostic factors: more randomized children had older siblings, did not attend day care and had mothers with a lower educational level than the nonrandomized children. These factors, however, did not modify the outcome. No differences were found in mean hearing levels between the randomized and nonrandomized children: in both the randomized and nonrandomized children ventilation tubes improved the hearing level, especially after 6 months. However, in the long term (12 months), the hearing levels were equal again. The results of the randomized and nonrandomized patients were comparable. The results of this trial appear to be generalizable to the total domain population. The procedure of following up both randomized and nonrandomized patients is recommended when there is concern about selective participation and reduced generalizability. This study aimed to compare the effects of mother's milk, sucrose and pacifier use to overcome pain during painful interventions to the newborns on the crying time and pain.
                Various non-pharmacological methods are used to overcome the pain associated with painful interventions with newborns.
                A prospective, randomised, controlled study involved 120 newborns in Turkey.
                The population consisted of healthy newborns hospitalised in the gynaecology clinics of Trabzon Delivery and Children's Diseases hospital between February 2007-January 2008. The newborns who had blood sampling by heel stick were divided into four groups: mother's milk, sucrose, pacifier and control groups with 30 newborns in each. Data collection was performed using an information form on the newborn characteristics, which was developed by the researchers in the light of literature, clinical IR ear thermometer ET1 for temperature measurement, OXIMAX N-65 Pulse oxymeter for oxygen saturation and heart rate and neonatal infant pain scale for the measurement of the behavioural responses of newborns. Results.  No differences were determined between the groups for heart rate and oxygen saturation in the newborns during painful interventions (p > 0·05). Sucrose followed by pacifier was the most effective method of reducing the crying time in the newborns.
                The results indicate that all three practices reduce the behavioural responses to pain at a higher rate than in the control group.
                Health care personnel should perform painful interventions to the newborns while the babies are held by their mothers and during the procedure use of sucrose should be the primary choice.
                © 2010 Blackwell Publishing Ltd.
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.