Osteopathic treatment of infants with infantile colic/excessive crying

Not Applicable

• Conditions: R10.4; Other and unspecified abdominal pain

• Registration Number: DRKS00025867
• Lead Sponsor: Akademie für Osteopathie e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-10
• Study Completion: 2022-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Neuropediatric findings unremarkable,
- Fulfillment of Rome IV criteria
- Birth weight > 2500
- Informed consent and sufficient knowledge of the German language from at least one parent

Exclusion Criteria

- U2 or U3 examinations by the pediatrician must be performed and without findings that would preclude participation in the study
- Infants will be excluded if they have active comorbidities that require medical treatment at the time of enrollment in the study (e.g., medication such as antibiotics, failure to thrive, GERD, gastrointestinal tract disorders, other etiologic predisposing factors for irritability)
- In the event of acute fever (or acute illness), enrollment in the study will be postponed until symptoms have resolved
- Physical therapy or manual treatment already in progress

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Do osteopathic treatments of infants with infantile colic/excessive crying (according to Rome IV criteria) have an impact on the subjectively perceived distress of the parents compared to routine care (usual care)? measured with a visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Recording of average daily crying time over 21 days (diary), total crying time over 21 days, crying intensity (NRS), parent survey: Satisfaction and confidence (Karitane confidence Scale), adverse event data.