Status:
COMPLETED
Neurodevelopmental Outcomes in Craniosynostosis Repair
Lead Sponsor:
University of Arkansas
Conditions:
Craniosynostoses
Eligibility:
All Genders
Up to 4 years
Phase:
NA
Brief Summary
Context: Craniosynostosis is a common craniofacial abnormality which can be associated with various clinical syndromes. Though it has been established that children with craniosynostosis score lower o...
Detailed Description
Craniosynostosis, the premature ossification and fusion of one or more cranial sutures, is a common craniofacial abnormality occurring in 1 of 2,000 live births. 1 2 Craniosynostosis can lead to incre...
Eligibility Criteria
Inclusion
- Up to 500 children, for all subjects, age of initial study entry: one test group between 3-6 months old( endoscopic assisted) , and the other 6-24 months of age ( open CVR) ) once enrolled, children will be included until 4 years of age.
- Diagnosed with craniosynostosis, single or multiple suture
- Babies with craniosynostosis syndrome including but not limited to Pfieffers, Aperts, Crouzons,and Menkes.
- Approximately 60 age-matched controls (3 in each group) not diagnosed with craniosynostosis syndrome, stratified by age groups starting at 3 months, 5 months, 7 months, 9 month 11 months, 13 months, 15 months, 17 months, 19 months, then every 3 months, 22 months, 25 months, 28 months, 31 months, 34 months, 37 months,40 months,43 months,46 months,49 months.
Exclusion
- Children not meeting the inclusion criteria
- Children with traumatic brain injury, brain cancer, or VP shunt that could affect development.
- Children who have already undergone CVR repair
- Developmentally Normal children who cannot undergo or cannot be still for an awake or asleep non-sedated MRI
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04072783
Start Date
July 8 2021
End Date
December 31 2024
Last Update
February 24 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205