Monitoring System for Cranial Orthoses

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a special helmet used for babies with certain head shape issues, like plagiocephaly or brachycephaly. These conditions happen when a baby's head develops an unusual shape due to pressure on one part of the head. The study aims to understand how long babies wear these helmets and how well they fit, which can help ensure they work effectively as the baby grows.

To participate in this trial, infants who need this helmet treatment are eligible. This means they should have a diagnosed head shape problem. However, infants with other specific conditions affecting head growth or those whose caregivers don’t speak English are not eligible. Families who take part can expect to help researchers gather important information about the use of these helmets, which could improve treatment for future babies with similar issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)
• Exclusion Criteria:
• • non-English speaking caregivers
• • infants with craniosynostosis or those not indicated for cranial remolding
• • infants with developmental comorbidities which affect cranial growth