Clinical trial NCT01761331: Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infantile Colic
Keywords: infant, colic, crying, acupuncture, stooling, sleep
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Ekhagastiftelsen
First posted: 2013-01-04
Enrollment: 147
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: change in crying
timeFrame: mean values for crying during the baseline week, during each of the two intervention weeks and during the week after the last treatment
Secondary outcomes:
measure: change in stooling
timeFrame: mean values for stooling during the baseline week, during each of the two intervention weeks and during the week after the last treatment
Other outcomes:
measure: Change in hours of sleep
timeFrame: 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
measure: side effects
timeFrame: each of the four visits to the study CHC and one week after the last visit
measure: Blinding
timeFrame: each of the four visits to the study CHC and one week after the last visit
Locations:
city: Arlöv
country: Sweden
facility: Arlöv vårdcentral, BVC
state: Skåne
city: Askim
country: Sweden
facility: Askims vårdcentral, BVC
state: Västra Götaland
city: Karlskrona
country: Sweden
facility: Tullgårdens BVC
city: Linköping
country: Sweden
facility: Valla Vårdcentral, BVC
state: Östergötland
Study officials:
affiliation: Lund University
name: Kajsa Landgren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landgren K, Hallstrom I, Tiberg I. The effect of two types of minimal acupuncture on stooling, sleeping and feeding in infants with colic: secondary analysis of a multicentre RCT in Sweden (ACU-COL). Acupunct Med. 2021 Apr;39(2):106-115. doi: 10.1177/0964528420920308. Epub 2020 May 6.
citation: Landgren K, Hallstrom I. Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL). Acupunct Med. 2017 Jun;35(3):171-179. doi: 10.1136/acupmed-2016-011208. Epub 2017 Jan 16.
citation: Landgren K, Tiberg I, Hallstrom I. Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL. BMC Complement Altern Med. 2015 Sep 14;15:325. doi: 10.1186/s12906-015-0850-x.