Effects of Acupuncture in the Treatment of Infant Colic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arne Fetveit, University of Oslo
ClinicalTrials.gov Identifier:
NCT00907621
First received: May 21, 2009
Last updated: March 15, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Infant Colic
Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Change in Crying Time Per 24 Hour Period. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Crying time per 24 hour period at baseline and post treatment


Secondary Outcome Measures:
  • Parents Evaluation of Benefit to the Child. [ Time Frame: 5 days, 1 , and 4 weeks after the first treatment ] [ Designated as safety issue: No ]

    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.



Enrollment: 90
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture

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 on infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:

Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.

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.
Other Name: Seirin 020x15mm sterile acupuncture needle
No Intervention: Control

Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:

Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.

The Control group will have no intervention.


  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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."
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907621

Locations
Norway
Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo.
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Investigators
Principal Investigator: Holgeir Skjeie, MD Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arne Fetveit, Associate Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT00907621     History of Changes
Other Study ID Numbers: infant colic
Study First Received: May 21, 2009
Results First Received: November 22, 2013
Last Updated: March 15, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Infant Colic
Acupuncture
General Practice

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on April 23, 2015