OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Launched by OSTEOPATHY'S PROMISE TO CHILDREN · Apr 28, 2023
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
The OPT-IN trial is studying how well osteopathic manipulative treatment (OMT) works for infants with a condition called positional plagiocephaly, which is a type of head shape deformity that can occur when babies spend too much time in one position. The researchers want to find out if OMT can improve the head shape of babies better than the standard care method, which involves repositioning the baby’s head to encourage a more symmetrical shape. In this study, infants under 4 months old will be randomly placed into one of two groups: one group will receive OMT, while the other will follow the standard repositioning approach. After 8 weeks, the groups will switch treatments.
To participate, infants must be diagnosed with positional plagiocephaly and be under 4 months old. The study is open to all genders and aims to recruit 122 babies. Participants will undergo both treatments over a total of 24 months, with the first 8 weeks focused on OMT or repositioning, followed by a crossover to the other treatment. Parents should be aware that their child will need to attend 8 OMT sessions and 2 follow-up measurement sessions. This trial is currently recruiting participants and aims to better understand how different treatment approaches can help improve head shape in infants.
Gender
ALL
Eligibility 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
About Osteopathy's Promise To Children
Osteopathy's Promise to Children is a dedicated clinical trial sponsor focused on advancing the understanding and application of osteopathic principles in pediatric healthcare. Committed to enhancing the well-being of children, the organization conducts rigorous research to evaluate the efficacy of osteopathic treatments and their potential benefits in addressing various pediatric conditions. By fostering collaboration among healthcare professionals, researchers, and families, Osteopathy's Promise to Children aims to promote evidence-based practices and improve health outcomes for young patients, ensuring a brighter and healthier future for children everywhere.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
San Diego, California, United States
Patients applied
Trial Officials
Kimberly J Wolf, DO
Principal Investigator
Osteopathy's Promise to Children
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported