OPT-IN: Osteopathic Manipulative Treatment Compared to Standard Repositioning for Infants with Positional Plagiocephaly

What this Trial Is About

Researchers are evaluating the effects of osteopathic manipulative treatment (OMT) compared to standard repositioning care in infants diagnosed with positional or deformational plagiocephaly. The study aims to see if OMT can improve cranial symmetry better than the usual pediatric repositioning methods. This randomized crossover trial plans to enroll 122 infants under 4 months of age, with the study lasting about 24 months including follow-up. Participants will be randomly assigned to one of two groups: one group will receive OMT once a week for 8 weeks, focusing on gentle manual techniques to improve head shape, while the other group will receive standard care involving parental repositioning guidance. After 8 weeks, each infant will switch to the other group for another 8 weeks, allowing comparison within the same participant. Parents will receive standardized materials to support repositioning care. During the study, infants will be monitored for cranial symmetry using measurements like the Cranial Vault Asymmetry Index, head circumference, and weight over 2 years. Medical histories and developmental milestones will also be tracked for 12 months. The study includes scheduled assessments and follow-ups to evaluate changes and ensure safety throughout the 24-month participation period.

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates