Effects of Acupuncture in the Treatment of Infant Colic

University of Oslo

Status and phase: Completed; Phase 2

Conditions: Infant Colic

Treatments: Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Study type: Interventional

Funder types: Other

Identifiers

NCT00907621

infant colic

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 3 weeks to 3 months old

Volunteers: Accepts 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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 2 patient groups

Acupuncture

Experimental group

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.

Treatment:

Procedure: Acupuncture with Seirin 020x15 mm sterile acupuncture needle

Control

No Intervention group

Description:

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.