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Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture.

ABSTRACT: The aim was to describe the feeding- and stooling patterns of infants with colic and evaluate the influence of minimal acupuncture.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.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.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.ClinicalTrials.govID NCT00860301.

SUBMITTER: Landgren K

PROVIDER: S-EPMC3212902 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture.

Landgren Kajsa K Kvorning Nina N Hallström Inger I

BMC complementary and alternative medicine 20111011

<h4>Background</h4>The aim was to describe the feeding- and stooling patterns of infants with colic and evaluate the influence of minimal acupuncture.<h4>Methods</h4>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 c ...[more]

PMID: 21989212

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Project description:BackgroundDespite weak evidence, the use of acupuncture has increased in infantile colic. The only three randomized trials conducted evaluated standardized minimal acupuncture in one single point. Two showed effect but one did not so further research is necessary. The aims of the study are 1) to test if results in earlier trials conducted in private acupuncture clinics can be repeated at Child Health Centers (CHC) and 2) to compare the effect of two types of acupuncture and no acupuncture in infants with colic at CHC.Methods/designa multicenter randomized controlled three-armed trial for infantile colic conducted in four regions of Sweden. Alongside the standard program at their regular Child Health Center infants visit a study center twice a week for 2 weeks. The infants are randomly allocated into three groups. According to the power analysis, 144 otherwise healthy infants aged 2-9 weeks old, who - according to parents' registration in a diary - are crying and/or fussing more than three hours per day, more than 3 days per week will be included. Parents register daily in the diary during the baseline week, two intervention weeks, and one more week directly after the last study visit. At four study visits at the Child Health Center parents meet a nurse for 20-30 min to receive advice and support. The nurse and the parents are blinded for group allocation. Infants are carried to another room, where they spend five minutes with an acupuncturist. Infants randomized to group A receive standardized minimal acupuncture in LI4. Group B receive individualized acupuncture where, according to symptoms, the acupuncturist can choose between the points Sifeng, LI4, and ST36. Group C receives no acupuncture. The primary outcome is relative difference in crying, counted in minutes. Secondary outcomes are number of infants fulfilling the criteria for colic, and changes in sleep and stooling frequency. Adverse events and blinding are recorded. Recruitment started in January 2013. During the first 14 months 93 patients were included. Data collection continues until May 2015. No interim analyses have been conducted.DiscussionThe study will provide information about the efficacy and safety of acupuncture as a complement to usual care in infants with colic.Trial registrationDecember 29, 2012: ClinicalTrials.gov NCT01761331.

Project description:IntroductionAs the main manifestation of gallstone disease, biliary colic (BC) is an episodic attack that brings patients severe pain in the right upper abdominal quadrant. Although acupuncture has been documented with significance to lead to pain relief, the immediate analgesia of acupuncture for BC still needs to be verified, and the underlying mechanism has yet to be covered. Therefore, this trial aims first to verify the immediate pain-alleviation characteristic of acupuncture for BC, then to explore its influence on the peripheral sensitised acupoint and central brain activity.Methods and analysisThis is a randomised controlled, paralleled clinical trial, with patients and outcome assessors blinded. Seventy-two patients with gallbladder stone disease presenting with BC will be randomised into a verum acupuncture group and the sham acupuncture group. Both groups will receive one session of immediate acupuncture treatment. Improvements in patients' BC will be evaluated by the Numeric Rating Scale, and the pain threshold of acupoints will also be detected before and after treatment. During treatment, brain neural activity will be monitored with functional near-infrared spectroscopy (fNIRS), and the needle sensation will be rated. Clinical and fNIRS data will be analysed, respectively, to validate the acupuncture effect, and correlation analysis will be conducted to investigate the relationship between pain relief and peripheral-cerebral functional changes.Ethics and disseminationThis trial has been approved by the institutional review boards and ethics committees of the First Teaching Hospital of Chengdu University of Traditional Chinese Medicine, with the ethical approval identifier 2019 KL-029, and the institutional review boards and ethics committees of the First People's Hospital of Longquanyi District, with the ethical approval identifier AF-KY-2020071. The results of this trial will be disseminated through peer-reviewed publications and conference abstracts or posters.Trial registration numberCTR2000034432.

Project description:Neurobehavioral disabilities occur in 5-15% of preterm infants with an estimated 50-70% of very low birth weight preterm infants experiencing later dysfunction, including cognitive, behavioral, and social delays that often persist into adulthood. Factors implicated in poor neurobehavioral and developmental outcomes are hospitalization in the neonatal intensive care unit (NICU) and inconsistent caregiving patterns. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies can stop lesions from progressing, particularly when these strategies are used during the most sensitive periods of neural plasticity occurring months before term age. The purpose of this randomized trial is to test the effect of a patterned feeding experience on preterm infants' neurobehavioral organization and development, cognitive function, and clinical outcomes.This trial uses an experimental, longitudinal, 2-group design with 120 preterm infants. Infants are enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience from the first gavage feeding through discharge or to a control group receiving usual feeding care experience. The intervention involves a continuity of tactile experiences associated with feeding to train and build neuronal networks supportive of normal infant feeding experience. Primary outcomes are neurobehavioral organization as measured by Neurobehavioral Assessment of the Preterm Infant at 3 time points: the transition to oral feedings, NICU discharge, and 2 months corrected age. Secondary aims are cognitive function measured using the Bayley Scales of Infant and Toddler Development, Third Edition at 6 months corrected age, neurobehavioral development (sucking organization, feeding performance, and heart rate variability), and clinical outcomes (length of NICU stay and time to full oral feeding). The potential effects of demographic and biobehavioral factors (perinatal events and conditions of maternal or fetal/newborn origin and immunologic and genetic biomarkers) on the outcome variables will also be considered.Theoretically, the intervention provided at a critical time in neurologic system development and associated with a recurring event (feeding) should enhance neural connections that may be important for later development, particularly language and other cognitive and neurobehavioral organization skills.NCT01577615 11 April 2012.

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Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture.

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Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture.

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