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Completed
NCT06425172
Monitoring System for Cranial Orthoses
Conditions: Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Sex: All
Ages: 3 Months – 18 Months
Healthy volunteers: No
Enrollment: 12
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center Dallas Texas
Summary
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).
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
Source: ClinicalTrials.gov (NCT06425172). StuddyBuddy aggregates publicly available trial information.
