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Effects of Acupuncture in the Treatment of Infant Colic

Primary Purpose

Infant Colic

Status

Completed

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Acupuncture with Seirin 020x15 mm sterile acupuncture needle

About this trial

This is an interventional treatment trial for Infant Colic focused on measuring Infant Colic, Acupuncture, General Practice

Eligibility Criteria

3 Weeks - 3 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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."

Exclusion Criteria:

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."

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Crying Time Per 24 Hour Period.

Crying time per 24 hour period at baseline and post treatment

Secondary Outcome Measures

Parents Evaluation of Benefit to the Child.

Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified.

Full Information

NCT ID

NCT00907621

First Posted

May 21, 2009

Last Updated

March 15, 2015

Sponsor

University of Oslo

1. Study Identification

Unique Protocol Identification Number

NCT00907621

Brief Title

Effects of Acupuncture in the Treatment of Infant Colic

Official Title

Effects of Acupuncture in the Treatment of Infant Colic: A Prospective Multi-center Single Blinded Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oslo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infant Colic

Keywords

Infant Colic, Acupuncture, General Practice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Other Intervention Name(s)

Seirin 020x15mm sterile acupuncture needle

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Crying Time Per 24 Hour Period.

Description

Crying time per 24 hour period at baseline and post treatment

Time Frame

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 Outcome Measure Information:

Title

Parents Evaluation of Benefit to the Child.

Description

Parents subjective assessment of the childs condition, on a 5 point scale, with 1 being worse and 5 being completely well. The numbers are the actual evaluations on the time specified.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Weeks

Maximum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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." Exclusion Criteria: 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."

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Holgeir Skjeie, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

24228748

Citation

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.

Results Reference

result

PubMed Identifier

21450707

Citation

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.

Results Reference

derived

Learn more about this trial

Effects of Acupuncture in the Treatment of Infant Colic

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