Neurodevelopmental Outcomes in Craniosynostosis Repair

NACompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

July 8, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Craniosynostoses
Interventions
DIAGNOSTIC_TEST

MRI,DTI, functional MRI

"1. Patients will undergo testing with Pre- and and post-surgical MRI. The protocol will be Sagittal T1, Axial inversion recovery, T2, fluid-attenuated inversion recovery, susceptibility weighted image, diffusion weighted images, diffusion tensor imaging, resting state fMRI, sagittal 3D GRE / FFE or 3D T1 VIBE and tractography.~2. Once patients are identified, surgery is planned.The standard of care procedures fall into two categories based on age of presentation, clinician judgement and family preference all other things being equal. Both the endoscopic-assisted craniectomy and open CVR are standard of care procedures. Patients self-select into these groups. None of the surgery nor any aspect of it is experimental.~3. Patients are routinely examined for neurodevelopment pre- and post-operatively as part of American Cleft Palate Craniofacial Association guidelines.The Vineland Adaptive Behavior Scales are used up to and including age 4."

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
lead

University of Arkansas

OTHER