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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Lund University
Sponsor:
Collaborator:
Ekhagastiftelsen
Information provided by (Responsible Party):
Kajsa Landgren, Lund University
ClinicalTrials.gov Identifier:
NCT01761331
First received: December 29, 2012
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Infantile Colic
Other: Acupuncture
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 no Acupuncture

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Difference over time and between groups in reduction in % of colicky crying, crying and fussing in minutes/day


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The frequency of stooling per day


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 192
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
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.

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.

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.

  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761331

Contacts
Contact: Kajsa Landgren, PhD +46-462221880 kajsa.landgren@med.lu.se
Contact: Åsa Lefevre, coordinator +46-46221979 Asa.Lefevre@med.lu.se

Locations
Sweden
Arlöv vårdcentral, BVC Recruiting
Arlöv, Skåne, Sweden, 232 38
Contact: Kajsa Landgren, PhD    +46-462221880    kajsa.landgren@med.lu.se   
Contact: Åsa Lefevre, coordinator    +46-462221979    asa.lefevre@med.lu.se   
Principal Investigator: Kajsa Landgren, PhD         
Askims vårdcentral, BVC Recruiting
Askim, Västra Götaland, Sweden, 436 32
Contact: Kajsa Landgren, PhD    +46-462221880    kajsa.landgren@med.lu.se   
Contact: Åsa Lefevre    +46-462221979    Asa.Lefevre@med.lu.se   
Principal Investigator: Kajsa Landgren, PhD         
Tullgårdens BVC Recruiting
Karlskrona, Sweden, 371 85
Contact: Kajsa Landgren    +46-739321746    kajsa.landgren@med.lu.se   
Contact: Åsa Lefevre    +46-462221979    asa.lefevre@med.lu.se   
Principal Investigator: Kajsa Landgren, PhD         
Valla Vårdcentral, BVC Recruiting
Linköping, Östergötland, Sweden, 582 16
Contact: Kajsa Landgren, PhD    +46-462221880    kajsa.landgren@med.lu.se   
Contact: Åsa Lefevre, coordinator    +46-462221979    Asa.Lefevre@med.lu.se   
Principal Investigator: Kajsa Landgren, PhD         
Sponsors and Collaborators
Lund University
Ekhagastiftelsen
Investigators
Principal Investigator: Kajsa Landgren, PhD Lund University
  More Information

Additional Information:
No publications provided

Responsible Party: Kajsa Landgren, Principal Investigator, Lund University
ClinicalTrials.gov Identifier: NCT01761331     History of Changes
Other Study ID Numbers: LU-HSC-KL2013
Study First Received: December 29, 2012
Last Updated: March 22, 2013
Health Authority: Sweden: Lund University

Keywords provided by Lund University:
infant, colic, crying, acupuncture, stooling, sleep

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 22, 2014