Acupuncture in Infantile Colic

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Acupuncture in Infantile Colic - a Randomised Controlled Double Blind Clinical Study

Conditions
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Infantile Colic

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br> | Other: Acupuncture<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infantile colic