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Completed

NCT Number: NCT00860301

Acupuncture in Infantile Colic

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

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Key information

Conditions

Infantile Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

2 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Acupuncture Clinic

Helsingborg, 254 41, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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 One needle is inserted 1-3 mm in the point LI4 on one of the infants hands for one to three seconds and then withdrawn.

Primary outcomes

  1. If the rate of infants who still fulfil the colic criterion in each of the intervention weeks differ between groups.

    Time frame: First, second and third intervention weeks

Secondary outcomes

  1. If the time when infants are crying, fussing or have intense bouts of colicky symptoms in each of the intervention weeks differ between groups.

    Time frame: First, second and third intervention weeks

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Ekhagastiftelsen
  • General Maternity Hospital Foundation
  • Magn Bergvalls stiftelse

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2009
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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