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Acupuncture in Infantile Colic

Primary Purpose

Infantile Colic

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Acupuncture

About this trial

This is an interventional treatment trial for Infantile Colic focused on measuring infantile colic

Eligibility Criteria

2 Weeks - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Acupuncture Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.

Secondary Outcome Measures

If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups.

Full Information

NCT ID

NCT00860301

First Posted

March 11, 2009

Last Updated

March 11, 2009

Sponsor

Lund University

Collaborators

Ekhagastiftelsen, Magn Bergvalls stiftelse, General Maternity Hospital Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00860301

Brief Title

Acupuncture in Infantile Colic

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Lund University

Collaborators

Ekhagastiftelsen, Magn Bergvalls stiftelse, General Maternity Hospital Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infantile Colic

Keywords

infantile colic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture group

Arm Type

Experimental

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Inger Hallström, Professor

Organizational Affiliation

Lund University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Acupuncture Clinic

City

Helsingborg

ZIP/Postal Code

254 41

Country

Sweden

12. IPD Sharing Statement

Citations:

Citation

Landgren K.& Hallström I. Akupunkturbehandling vid spädbarnskolik - föräldrars upplevelser av barnets beteende före och efter behandling. Vård i Norden, vol.1, 26-31, 2005.

Results Reference

background

PubMed Identifier

21989212

Citation

Landgren K, Kvorning N, Hallstrom I. Feeding, stooling and sleeping patterns in infants with colic--a randomized controlled trial of minimal acupuncture. BMC Complement Altern Med. 2011 Oct 11;11:93. doi: 10.1186/1472-6882-11-93.

Results Reference

derived

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Acupuncture in Infantile Colic

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