Acupuncture in Infantile Colic

NCT00860301 | Completed

• 1 other identifier: 1-Landgren
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Infantile Colic

Keywords

infantile colic

Outcome Measures

Primary Outcomes (1)

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

  First, second and third intervention weeks

Secondary Outcomes (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.

  First, second and third intervention weeks

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Other: Acupuncture

Control group

NO INTERVENTION

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.

Interventions

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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.

Acupuncture group

Eligibility Criteria

• Age: 2 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weeks old otherwise healthy infants who are fussing/crying more than three hours/day, more than three days during one week

You may not qualify if:

• infants born before week 36
• infants who dont gain weight properly
• infants taking other medicine than dimethicone or lactobacillus reuteri

Sponsors & Collaborators

• Lund University: lead
• Ekhagastiftelsen: collaborator
• Magn Bergvalls stiftelse: collaborator
• General Maternity Hospital Foundation: collaborator

Study Sites (1)

Acupuncture Clinic

Helsingborg, 254 41, Sweden

Location

Related Publications (2)

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

  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.

  PMID: 21989212 DERIVED

MeSH Terms

Conditions

Colic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Inger Hallström, Professor

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: December 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 12, 2009

Record last verified: 2009-03

Locations

SE (1)