Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)
Condition: Infantile Colic
MeSH terms: Colic
Study type: Interventional
Phase: Phase 2/Phase 3

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 description: 
      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 with their Child Health
      Center (CHC), infants and their parents are invited to visit a study CHC twice a week for two
      weeks, where they meet a nurse for about 20 minutes. Parents can describe their situation,
      discuss the infant´s symptoms and get advice. This nurse is blinded to which group the infant
      is randomized to. She carries the baby to another room and hands over the infant to a nurse,
      trained in acupuncture. The acupuncture nurse randomizes the infants to one of three groups,
      following a randomization list produced by the research department at Lund University
      Hospital. Group A will get standardized minimal acupuncture: one needle is inserted about 3
      mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn.
      Group B will get individualized acupuncture in points chosen by the acupuncturists according
      to symptoms: maximum 5 needles are inserted about 3 mm in points recommended in a guideline
      produced for the trial after discussions with experienced pediatric acupuncturists. Needles
      are retained for maximum one minute. Group C will not get acupuncture but will otherwise be
      treated similarly: they will be with the acupuncture nurse for five minutes while she holds
      the hand of the baby and talks to it in a calm voice. The acupuncture nurse make notes about
      bleeding and other possible side effects, and if the baby is crying. After approximately five
      minutes the acupuncture nurse calls the study nurse who carries the baby back to the parents.
      At every visit the study nurse asks parents if they have noticed any side effects, and asks
      if parents believe their baby gets acupuncture or not.

      During the two intervention weeks and one week after the last visit to the study CHC parents
      register the infants behavior daily in a diary. Statistical analyses will be made from the
      diaries.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Minimal standardized acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn.
Individualized acupuncture: maximum 5 needles are inserted, about 3 mm deep, in points chosen by the acupuncturists according to symptoms, in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infant, colic, crying, acupuncture, stooling, sleep