Child and Infant Learning Project
- Conditions
- Craniosynostosis
- Registration Number
- NCT00077831
- Lead Sponsor
- Seattle Children's Hospital
- 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 left unilateral coronal. A case-matched "control" group of healthy, normal infants was also followed. This study, which is now in its second phase, is following this same cohort of children at the age of 7 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Neurodevelopment as assessed by the Bayley Scales of Infant Development II 1st assessment - post diagnosis, pre surgery. 2nd assessment - Target age 18 months. 3rd assessment - Target age 36 months.
- Secondary Outcome Measures
Name Time Method Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV Target age 7 years
Trial Locations
- Locations (4)
Children's Health Care of Atlanta
🇺🇸Atlanta, Georgia, United States
Northwestern University, Cleft Lip and Palate Institute
🇺🇸Westchester, Illinois, United States
St. Louis Children's Hospital / Washington University
🇺🇸St. Louis, Missouri, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Children's Health Care of Atlanta🇺🇸Atlanta, Georgia, United States