Phase 2 N=90 Randomized Single-blind Treatment

Effects of Acupuncture in the Treatment of Infant Colic

Infant Colic

Bottom Line

View on ClinicalTrials.gov: NCT00907621 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Change in Crying Time Per 24 Hour Period. — 220; 212; 230; 186 minutes crying time pr 24 hour

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acupuncture with Seirin 020x15 mm sterile acupuncture needle (Procedure)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Oslo
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Crying Time Per 24 Hour Period.	220; 212; 230; 186; 180; 185	—
SECONDARY Parents Evaluation of Benefit to the Child.	2.87; 2.78; 3.62; 3.27; 4.03; 3.51	—

Summary

Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture. The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture. The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.

Eligibility Criteria

Inclusion Criteria

Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of gestation.
Further fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying per day for more than 3 days a week for more than 3 weeks."

Exclusion Criteria

Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of gestation.
Not fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying pr.day for more than 3 days a week for more than 3 weeks."

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00907621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.