Clinical trial NCT00907621: Effects of Acupuncture in the Treatment of Infant Colic
Official title: Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant Colic
Keywords: Infant Colic
Acupuncture
General Practice
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2009-05-22
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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."

Primary outcomes:
measure: Change in Crying Time Per 24 Hour Period.
timeFrame: 6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.
Secondary outcomes:
measure: Parents Evaluation of Benefit to the Child.
timeFrame: 5 days, 1 , and 4 weeks after the first treatment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo.
Study officials:
affiliation: Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo
name: Holgeir Skjeie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov 15.
citation: Skjeie H, Skonnord T, Fetveit A, Brekke M. A pilot study of ST36 acupuncture for infantile colic. Acupunct Med. 2011 Jun;29(2):103-7. doi: 10.1136/aim.2010.003590. Epub 2011 Mar 29.