Monitoring the use of custom helmets for reshaping infant heads
A Monitoring System for Cranial Remolding Orthoses
University of Texas Southwestern Medical Center · NCT06425172
This study looks at how well custom helmets for reshaping babies' heads fit and how long infants wear them to help set better guidelines for their use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 3 Months to 18 Months |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06425172 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the wear time and fit of cranial remolding orthoses, which are custom helmets designed to help reshape an infant's head as they grow. Over the course of 11 weeks, participants will attend seven visits for measurements, fittings, and follow-ups, during which caregivers will log helmet wear time and any side effects. The study aims to establish objective monitoring standards for this standard-of-care treatment, which has been in use for over 20 years but lacks formal guidelines for assessment.
Who should consider this trial
Good fit: Ideal candidates are infants who require cranial remolding orthoses for conditions like plagiocephaly or brachycephaly.
Not a fit: Patients who may not benefit include those with craniosynostosis or developmental comorbidities affecting cranial growth.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and outcomes for infants undergoing treatment for head shape deformities.
How similar studies have performed: While cranial remolding has been used successfully for years, this specific approach to monitoring has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Tiffany Graham, MS — University of Texas Southwestern Medical Center
- Study coordinator: Tiffany Graham, MS
- Email: Tiffany.Graham@utsouthwestern.edu
- Phone: 2146458250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Plagiocephaly, Brachycephaly, Deformational Plagiocephaly, Deformational Posterior Plagiocephaly