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Search / Trial NCT04841590

Effects of Osteopathic Manual Therapy on Infant Colic

Launched by UNIVERSITY OF SEVILLE · Apr 9, 2021

Trial Information

Current as of April 26, 2025

Completed

Keywords

ClinConnect Summary

This clinical trial is studying how osteopathic manual therapy might help babies who suffer from colic, which is when infants cry a lot—often for more than three hours a day, at least three days a week, for several weeks. This common condition affects many newborns, and the goal of the study is to see if this therapy can reduce crying time, improve sleep, and lessen the severity of colic symptoms. Babies aged 2 to 12 weeks who meet specific criteria, like having excessive crying and normal growth patterns, may be eligible to participate.

If chosen for the study, participants will be randomly assigned to either a treatment group, receiving hands-on therapy from an experienced osteopath, or a control group, which will not receive any treatment. The study will involve three therapy sessions over a few weeks, and parents will keep a diary to track their baby's crying and sleeping patterns. The researchers will also assess changes in colic severity using a special questionnaire. This trial aims to provide safe and effective options for managing infant colic and give families some relief during a challenging time.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks.
  • Age 2 - 12 weeks.
  • Gestation equal to or greater than 38 weeks.
  • Birth weight equal to or greater than 2,500 grams.
  • Weight gain of at least 150 grams. per week.
  • Appropriate pediatric general physical examination (height, weight, head circumference and psychomotor development).
  • Sign the informed consent.
  • Exclusion Criteria:
  • Signs and / or symptoms of other pathologies.
  • Signs of lactose intolerance.
  • Having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein.
  • Having received the subjects and / or siblings, previous treatment with Osteopathy and / or Chiropractic.
  • Contraindication to the treatment and / or some of its techniques; presence of congenital malformations.

About University Of Seville

The University of Seville is a prestigious academic institution dedicated to advancing knowledge through innovative research and exceptional education. With a strong emphasis on interdisciplinary collaboration, the university actively engages in clinical trials aimed at enhancing patient care and medical outcomes. Its commitment to rigorous scientific inquiry and ethical standards positions it as a leading sponsor in the field of clinical research, fostering partnerships with healthcare professionals and institutions to drive advancements in medical science and improve public health.

Locations

Granada, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Patients applied

0 patients applied

Trial Officials

David Nuñez Fernandez, PT, MsC

Principal Investigator

University of Seville

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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