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Acupuncture in Infantile Colic

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ClinicalTrials.gov Identifier: NCT00860301
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : March 12, 2009
Sponsor:
Collaborators:
Ekhagastiftelsen
Magn Bergvalls stiftelse
General Maternity Hospital Foundation
Information provided by:
Lund University

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

Condition or disease Intervention/treatment Phase
Infantile Colic Other: Acupuncture Not Applicable

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  (Clinical Trial)
Actual Enrollment : 90 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


Information from the National Library of Medicine

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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

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

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 Posted: March 12, 2009    Key Record Dates
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