Acupuncture in Infantile Colic

March 11, 2009 updated by: Lund University

Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study

The purpose of this study is to investigate whether acupuncture influences:

  • the rate of infants who still fulfil the colic criterion after three intervention weeks
  • the time when the infants are crying, fussing or have intense bouts of colicky symptoms

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infantile colic is a common problem. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no known treatment that is both effective and harmless. Acupuncture releases different neurotransmitters and hormones, gives pain reduction and affects digestion. Acupuncture in infantile colic has not been studied in a scientific way even though the method is used in many countries. In this randomised study we will investigate if acupuncture affects symptoms in infantile colic.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden, 254 41
        • Acupuncture Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 2-8 weeks old otherwise healthy infants who are fussing/crying more than three hours/day, more than three days during one week

Exclusion Criteria:

  • infants born before week 36
  • infants who dont gain weight properly
  • infants taking other medicine than dimethicone or lactobacillus reuteri

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture group
Other: Acupuncture
Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse is alone with the infant for five minutes. Infants in the acupuncture group get acupuncture. One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.
No Intervention: Control group
Infants come to the clinic six times, are left alone for five minutes with the acupuncture nurse who hold its hand and talks to it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.
Time Frame: First, second and third intervention weeks
First, second and third intervention weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups.
Time Frame: First, second and third intervention weeks
First, second and third intervention weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Ekhagastiftelsen
Magn Bergvalls stiftelse
General Maternity Hospital Foundation

Investigators

  • Principal Investigator: Inger Hallström, Professor, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Landgren

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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