Osteopathic treatment for infants with head shape issues
Official title: OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Run by Osteopathy's Promise to Children · NCT05848895 · Data updated 2026-11-12
This study is testing if a special hands-on treatment can help babies with flat head syndrome get better results than just using regular repositioning methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 4 Months |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | Osteopathy's Promise to Children Academic / other |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | October 26, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT05848895 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are infants under 4 months of age diagnosed with positional plagiocephaly.
✕Probably not a fit
Patients with preterm birth, genetic syndromes, or craniofacial defects will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of osteopathic manipulative treatment (OMT) compared to standard repositioning care in infants diagnosed with positional plagiocephaly. Infants under 4 months of age will be randomly assigned to receive either OMT or standard care for 8 weeks, after which they will switch groups. The primary outcome is to measure improvements in cranial symmetry through anthropometric assessments. The study will involve a total of 122 participants.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective non-invasive option for correcting cranial asymmetry in infants.
How similar studies have gone: While there is limited data on the specific use of OMT for this condition, similar approaches in treating cranial deformities have shown promise.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusions: * Diagnosed with positional plagiocephaly * Under 4-months of age (between birth - 4 months) at the time of enrollment Exclusions: * Preterm birth (\<37 weeks) * Genetic syndromes * Craniofacial defects/deformities (e.g. cleft lip/palate) * Brachycephaly/scaphocephaly * Hypotonia * Hypertonia * Craniosynostosis * Head trauma or other neurological illnesses * Lost to follow up * Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions * Prior helmet therapy, physical therapy, or OMT before the date of enrollment
Where it's running
-
Osteopathic Center San Diego
San Diego, California, United States Recruiting
Study contacts
- Principal investigator: Kimberly J Wolf, DO — Osteopathy's Promise to Children
- Study coordinator: Kimberly J Wolf, DO
- Email: kimberly.wolf@the-promise.org
- Phone: 619-583-7611
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.