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Acupuncture in Infantile Colic

This study has been completed.
Sponsor:
Collaborators:
Ekhagastiftelsen
Magn Bergvalls stiftelse
General Maternity Hospital Foundation
Information provided by:
Lund University
ClinicalTrials.gov Identifier:
NCT00860301
First received: March 11, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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

Condition Intervention
Infantile Colic
 Other: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lund University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: First, second and third intervention weeks ] [ Designated as safety issue: Yes ]

Enrollment: 90
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.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.

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.

  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860301

Locations
Sweden
Acupuncture Clinic
Helsingborg, Sweden, 254 41
Sponsors and Collaborators
Lund University
Ekhagastiftelsen
Magn Bergvalls stiftelse
General Maternity Hospital Foundation
Investigators
Principal Investigator: Inger Hallström, Professor Lund University
  More Information

No publications provided by Lund University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Inger Hallström, Professor, Lund University
ClinicalTrials.gov Identifier: NCT00860301     History of Changes
Other Study ID Numbers: 1-Landgren
Study First Received: March 11, 2009
Last Updated: March 11, 2009
Health Authority: Sweden: Lund University

Keywords provided by Lund University:
infantile colic

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

ClinicalTrials.gov processed this record on May 19, 2013