| NCT ID | NCT06425172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Plagiocephaly |
| Study Type | OBSERVATIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12 participants in total. It began in 2024-08-19 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Tiffany Graham, MS
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06425172 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 18 Months, studying Plagiocephaly. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06425172 currently recruiting?
Yes, NCT06425172 is actively recruiting participants. Contact the research team at Tiffany.Graham@utsouthwestern.edu for enrollment information.
Where is the NCT06425172 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06425172 clinical trial?
NCT06425172 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Tiffany Graham, MS at University of Texas Southwestern Medical Center. The trial plans to enroll 12 participants.