To learn more about the cognitive and motor development of babies born with a craniofacial birth defect called craniosynostosis.

Condition	Treatment or Intervention
Craniosynostosis	Behavior: neurobehavioral development

Further Study Details: 

Expected Total Enrollment:  500

Abstract: In this multi-site, 5-year longitudinal study, infants with one of four types of single-suture craniosynostosis will be recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal (n = 250). A case-matched "control" group of healthy, normal infants (n = 250) will also be followed. The long-term objectives are to chart the neurobehavioral course of single-suture fusions and to better understand how the developing cranium affects human brain growth and function. Specific aims are to : (1) Clarify the neurobehavioral development and parental adjustment of infants with and without single-suture fusions at three time points in infancy and early childhood (just prior to cranioplastic surgery and twice post-surgery, at 18 and 36 months of age); (2) Among children with craniosynostosis, clarify relations between neurobehavioral development and abnormality in bone and brain tissue as indicated by measures taken from pre-surgery CT scans; (3) Among children with unicoronal synostosis, clarify relations between neurobehavioral development and presence of mutations; (4) Develop predictive models of 36-month outcomes for infants with craniosynostosis; and (5) Determine the relation between age of cranioplastic surgery and pre- and post-surgery neurobehavioral development.

Ages Eligible for Study:  2 Months   -   3 Years,  Genders Eligible for Study:  Both

Criteria

• 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 or problems 33 months or younger at time of enrollment (male or female).

Georgia
      Children's Health Care of Atlanta, Atlanta,  Georgia,  30342,  United States; Recruiting
Illinois
      Northwestern University, Cleft Lip and Palate Institute, Westchester,  Illinois,  60154,  United States; Recruiting
Missouri
      St. Louis Children's Hospital Washingtin University, St. Louis,  Missouri,  63110,  United States; Recruiting
Washington
      Children's Hospital and Regional Medical Center, Seattle,  Washington,  98105,  United States; Recruiting

Study ID Numbers:  NIDCR-13813
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  February 12, 2004
ClinicalTrials.gov Identifier:  NCT00077831
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08