Endoscopic strip craniectomy for treating sagittal craniosynostosis in infants
Endoscopic Strip Craniectomy for Treatment of Isolated, Non-syndromic Sagittal Craniosynostosis
This study is testing two different surgical methods for treating a head shape problem in babies under 6 months to see which one helps their heads grow better and look nicer after a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | N/A to 6 Months |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04721769 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of endoscopic strip craniectomy (ESC) with and without lateral osteotomies for treating isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age. The study is prospective and randomized, focusing on cranial expansion and aesthetic outcomes one year post-surgery. Participants will receive standard care, including preoperative and postoperative measurements and helmet therapy. The primary outcome is the degree of cranial expansion, while secondary outcomes include aesthetic appearance and various intraoperative clinical variables.
Who should consider this trial
Good fit: Ideal candidates are infants under 6 months of age diagnosed with isolated, non-syndromic sagittal craniosynostosis.
Not a fit: Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing surgical techniques for better cranial expansion and aesthetic results in infants with sagittal craniosynostosis.
How similar studies have performed: Previous studies have shown no significant differences between the two procedural variants, but this study aims to provide more comprehensive data on aesthetic outcomes, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with isolated, non-syndromic sagittal craniosynostosis under 6 months of age who present to Texas Children's Hospital. Exclusion Criteria: * Patients who are unable to undergo endoscopic strip craniectomy by 6 months of age.
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: David F Bauer, MD, MPH — Baylor College of Medicine
- Study coordinator: David F Bauer, MD, MPH
- Email: dfbauer@texaschildrens.org
- Phone: 832-822-1282
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.