Effects of Acupuncture in the Treatment of Infant Colic

NCT00907621 | Completed Phase 2 Results

• 1 other identifier: infant colic
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Standardized acupuncture treatment for infant colic is a common treatment in general practice for doctors educated in medical acupuncture. The investigators plan to study whether the perceived opinion on positive results can be verified in a multi-center clinical trial. The investigators aim to measure the effect of standardized acupuncture treatment, three repeated sessions, on infant colic in a randomized singe blinded prospective multi-center study, starting September 2009. The study will be done in thirteen locations in Norway by specialists in General Practice trained in acupuncture. The investigators intend to include a total of 130 patients, 65 in the intervention group and 65 in the control group.

Conditions

Infant Colic

Keywords

Infant Colic; Acupuncture; General Practice

Outcome Measures

Primary Outcomes (1)

• Change in Crying Time Per 24 Hour Period.

  Crying time per 24 hour period at baseline and post treatment

  6 time points measured: First, second and third intervention day, one day after last intervention, one week after last intervention and one month after last intervention. All time points measured in 24 hours.

Secondary Outcomes (1)

• Parents Evaluation of Benefit to the Child.

  5 days, 1 , and 4 weeks after the first treatment

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture with Seirin 020x15 mm sterile acupuncture needle: Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36 on infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition: Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.

Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Control

NO INTERVENTION

Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition: Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks. The Control group will have no intervention.

Interventions

Acupuncture with Seirin 020x15 mm sterile acupuncture needle PROCEDURE

Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.

Also known as: Seirin 020x15mm sterile acupuncture needle

Acupuncture

Eligibility Criteria

• Age: 3 Weeks - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants under 3 months of age with birth weight over 2500 g and/or over 36th week of gestation.
• Further fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying per day for more than 3 days a week for more than 3 weeks."

You may not qualify if:

• Infants over 3 months of age with birth weight under 2500 g and/or under 36th week of gestation.
• Not fulfilling Wessel et al criteria for infant colic: "Paroxystic uncontrollable crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying pr.day for more than 3 days a week for more than 3 weeks."

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo.

Oslo, Norway

Location

Related Publications (2)

• Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov 15.

  PMID: 24228748 RESULT

• Skjeie H, Skonnord T, Fetveit A, Brekke M. A pilot study of ST36 acupuncture for infantile colic. Acupunct Med. 2011 Jun;29(2):103-7. doi: 10.1136/aim.2010.003590. Epub 2011 Mar 29.

  PMID: 21450707 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

Limitations and Caveats

Our choice of acupuncture points and technique could be inferior to other more potent acupuncture approaches.

Results Point of Contact

• Title: Dr. Holgeir Skjeie
• Organization: Department of General practice, University of Oslo

Holgeir.Skjeie@medisin.uio.no

+4722850550

Study Officials

• Holgeir Skjeie, MD

  Institute of Primary Care and Community Health, Faculty of Medicine, University of Oslo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 17, 2015
• Results First Posted: March 17, 2015

Record last verified: 2015-03

Locations

NO (1)