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

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ClinicalTrials.gov Identifier: NCT01761331
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
Ekhagastiftelsen
Information provided by (Responsible Party):
Kajsa Landgren, Lund University

Tracking Information
First Submitted Date  ICMJE December 29, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date June 28, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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 Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01761331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 3, 2013)
  • Change in hours of sleep [ Time Frame: mean values for sleep and length of undisturbed sleep during the baseline week, during each of the two intervention weeks and during the week after the last treatment ]
    Hours of sleep per day
  • side effects [ Time Frame: each of the four visits to the study CHC and one week after the last visit ]
    At each visit parents will be asked by the study nurse whether they have noticed any side effects that they believe can be associated with acupuncture. One week after the last visit they will, by telephone, be asked the same question by the study coordinator.
  • Blinding [ Time Frame: each of the four visits to the study CHC and one week after the last visit ]
    At each visit parents will be asked by the study nurse whether they believe that their infant is allocated to acupuncture or not. One week after the last visit they will, by telephone, be asked the same question by the study coordinator.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)
Official Title  ICMJE Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial Comparing Acupuncture in a Standardized Point, Acupuncture in Individually Chosen Points and no Acupuncture
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infantile Colic
Intervention  ICMJE Other: Acupuncture

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.

Study Arms  ICMJE
  • Active Comparator: Group A: Standardized 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, trained in acupuncture, is alone with the infant for five minutes. Intervention: Infants in the standardized acupuncture group get 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.
    Intervention: Other: Acupuncture
  • Active Comparator: Group B: Individualized 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, trained in acupuncture, is alone with the infant for five minutes. Infants in the individualized acupuncture group get 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. Needles are retained for maximum one minute.
    Intervention: Other: Acupuncture
  • No Intervention: Group C: No 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, trained in acupuncture, is alone with the infant for five minutes. The nurse hold the infant´s hand and talks to it but no acupuncture is given.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2016)
147
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
192
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • otherwise healthy infants
  • crying/fussing more than three hours/day more than three days in the same week
  • has tried cow´s milk protein free diet for at least five days

Exclusion Criteria:

  • born before week 36
  • has tried acupuncture treatment
  • dont gain weight properly
  • taking other medicine than dimethicone or lactobacillus reuteri
  • parents who don´t understand Swedish
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 8 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761331
Other Study ID Numbers  ICMJE LU-HSC-KL2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kajsa Landgren, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Ekhagastiftelsen
Investigators  ICMJE
Principal Investigator: Kajsa Landgren, PhD Lund University
PRS Account Lund University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP