Acupuncture in Infantile Colic

Infantile Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860301
• Other study ID #: 1-Landgren
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: March 11, 2009
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2009
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Lund University
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Other:
• Acupuncture
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.

Locations

Country	Name	City	State
Sweden	Acupuncture Clinic	Helsingborg

Sponsors (4)

Lead Sponsor	Collaborator
Lund University	Ekhagastiftelsen, General Maternity Hospital Foundation, Magn Bergvalls stiftelse

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes