Effects of Acupuncture in the Treatment of Infant Colic

Infant Colic Clinical Trial

Official title:

Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907621
• Other study ID #: infant colic
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2009
• Last updated: March 15, 2015
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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."

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infant Colic

Intervention

Procedure:
• Acupuncture with Seirin 020x15 mm sterile acupuncture needle
Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.

Locations

Country	Name	City	State
Norway	Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo.	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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

Outcome

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