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Acupuncture in Infantile Colic - A Randomised Trial.

NCT05894798 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-02-17

No results posted yet for this study

Summary

About 10 per cent of all new born babies in Sweden have infant colic. This may affect the the whole family and the early connection between the baby and the parents. Although, there are no effective and safe treatment. Acupuncture is an environmental friendly method that affects pain, anxiety, sleep and the function of gastrointestinal system. Several studies have shown various results, and there are a need for high-qualitative randomised controlled trials to investigate the proposed effect further. 128 children will be randomised into two groups; acupuncture at LI4 or no acupuncture, parents will be blinded. Statistical calculations will be performed on the content of the diaries (bowel movement frequency, crying time, feeding). Registration of crying/crying in connection with acupuncture treatment, i.e. when the needle touches the skin or later until the needle is removed and 30 seconds after.

Conditions

  • Infant, Newborn, Diseases
  • Colic, Infantile
  • Acupuncture

Interventions

OTHER

Acupuncture

Acupuncture at point LI 4 in the thumb grip on the upper side of the hand, bilaterally, with a sterile disposable needle of dimension 0.20 x 13 mm. The stitch is approximately three mm deep. The needle is allowed to remain in place for about 30 seconds

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Veronica Milos Nymberg · Lund University/ Region Skane

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2050-12-31
Primary Completion
2060-12-31
Completion
2060-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894798 on ClinicalTrials.gov