Monitoring System for Cranial Orthoses

Completed

Conditions studied: Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly

In brief

This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).

Key facts

Study ID

NCT06425172

Run by

University of Texas Southwestern Medical Center

People needed

12

Starts

2024-08-19

Expected to finish

2026-03-12

Last updated by the study team

2026-07-22

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly / brachycephaly)

You may not qualify if…

• non-English speaking caregivers
• infants with craniosynostosis or those not indicated for cranial remolding
• infants with developmental comorbidities which affect cranial growth

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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