Acupuncture in Infantile Colic

NCT ID: NCT00860301

Last Updated: 2009-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-03-31

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.

Conditions

Infantile Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture group

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ekhagastiftelsen

OTHER

Sponsor Role: collaborator

Magn Bergvalls stiftelse

UNKNOWN

Sponsor Role: collaborator

General Maternity Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Lund University

Principal Investigators

Inger Hallström, Professor

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Acupuncture Clinic

Helsingborg, , Sweden

Countries

Sweden

References

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

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 21989212 (View on PubMed)

Other Identifiers

1-Landgren

Identifier Type: -

Identifier Source: org_study_id