Infant Colic Clinical Trial
Official title:
Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 3 Months |
Eligibility |
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." |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo. | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo |
Norway,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Crying Time Per 24 Hour Period. | Crying time per 24 hour period at baseline and post treatment | 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. | No |
Secondary | Parents Evaluation of Benefit to the Child. | Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified. |
5 days, 1 , and 4 weeks after the first treatment | No |
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