Craniosynostosis
Conditions
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.
Interventions
BEHAVIORALneurobehavioral development
observational study of infant and child development
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Seattle Children's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Months to 7 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV | Target age 7 years |
Countries
United States
Outcome results
None listed