Status:
COMPLETED
Child and Infant Learning Project
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Craniosynostosis
Eligibility:
All Genders
2-7 years
Brief Summary
To learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.
Detailed Description
In the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and lef...
Eligibility Criteria
Inclusion
- Enrollment criteria at Phase 1:
- Confirmed diagnosis of single-suture, nonsyndromic craniosynostosis (sagittal, metopic, unilateral coronal, or lambdoid)
- Corrective (cranioplastic) surgery not yet performed
- Child born at 34 weeks gestation or later
- Absence of neurological conditions/significant health problems
- 33 months or younger at time of enrollment (male or female).
- Enrollment criteria at Phase 2:
- All participants enrolled in phase 1 are invited to participate in phase 2.
Exclusion
Key Trial Info
Start Date :
September 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
535 Patients enrolled
Trial Details
Trial ID
NCT00077831
Start Date
September 1 2001
End Date
June 1 2015
Last Update
July 21 2015
Active Locations (4)
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1
Children's Health Care of Atlanta
Atlanta, Georgia, United States, 30342
2
Northwestern University, Cleft Lip and Palate Institute
Westchester, Illinois, United States, 60154
3
St. Louis Children's Hospital / Washington University
St Louis, Missouri, United States, 63110
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105