Clinical Trial: Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial Comparing Acupuncture in a Standardized Point, Acupuncture in Individually Chosen Points and n

Brief Summary: The purpose of this prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic. Group A will get standardized minimal acupuncture in LI4, group B will get individualized acupuncture in different points according to symptoms and group C will not get acupuncture. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.

Detailed Summary:

Infantile colic is a common problem, affecting 10-20% of newborns. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no safe and effective drug and the use of complementary medicine is increasing in spite of weak or no evidence. Acupuncture releases different neurotransmitters and hormones, is calming, gives pain reduction and affects digestion. Therefore it is reasonable that acupuncture can have effect in colic. Acupuncture in infantile colic has shown promising results in the few scientific trials conducted. These trials have evaluated the effect of standardized minimal acupuncture in the acupuncture points Large Intestine 4 (LI4) (two trials) or Stomach 36 (ST36) (one recent trial). In this prospective randomized three armed, multi center study performed at Child Health Centers in three towns, the effect of acupuncture in reducing symptoms in infants, 2-8 weeks old, with colic will be investigated. Two types of acupuncture: standardized minimal acupuncture in LI4 and individualized acupuncture in different points according to symptoms will be compared to an untreated group. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.

Parents will get information about the trial from nurses and doctors at Child Health Centers (CHC) or from a web-site (www.spädbarnskolik.se). Parents who are interested in letting their infant participate in the trial get further information and sign informed consent. The trial is approved by the ethical board at Lund University.

Infant´s crying, fussing, sleep, feeding and stooling will be registered in a diary during a baseline week. Infants who cry/fuss more than three hours/day, more than three days during this week is included and randomized. Beside their ordinary contacts wi
Sponsor: Lund University

Current Primary Outcome: change in crying [ Time Frame: mean values for crying during the baseline week, during each of the two intervention weeks and during the week after the last treatment ]

Difference over time and between groups in reduction in % of colicky crying, crying and fussing in minutes/day


Original Primary Outcome: Same as current

Current Secondary Outcome: change in stooling [ Time Frame: mean values for stooling during the baseline week, during each of the two intervention weeks and during the week after the last treatment ]

The frequency of stooling per day


Original Secondary Outcome: Same as current

Information By: Lund University

Dates:
Date Received: December 29, 2012
Date Started: January 2013
Date Completion:
Last Updated: June 25, 2016
Last Verified: June 2016