We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture in Infantile Colic

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860301
First Posted: March 12, 2009
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ekhagastiftelsen
Magn Bergvalls stiftelse
General Maternity Hospital Foundation
Information provided by:
Lund University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study

Resource links provided by NLM:


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 ]

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 ]

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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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

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
First Submitted: March 11, 2009
First Posted: March 12, 2009
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by Lund University:
infantile colic

Additional relevant MeSH terms:
Colic
Infant, Newborn, Diseases