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| Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
| Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
| ClinicalTrials.gov Identifier: | NCT00077831 |
Purpose
To learn more about the cognitive and motor development of babies born with a craniofacial birth defect called craniosynostosis.
| Condition | Intervention |
|
Craniosynostosis |
Behavioral: neurobehavioral development |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Case Control, Prospective Study |
| Official Title: | Neurobehavioral Correlates of Neurobehavioral Correlates of Craniosynostosis |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | May 2007 |
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.
Eligibility
| Ages Eligible for Study: | 2 Months to 3 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| United States, Georgia | |||||
| Children's Health Care of Atlanta | |||||
| Atlanta, Georgia, United States, 30342 | |||||
| United States, Illinois | |||||
| Northwestern University, Cleft Lip and Palate Institute | |||||
| Westchester, Illinois, United States, 60154 | |||||
| United States, Missouri | |||||
| St. Louis Children's Hospital Washingtin University | |||||
| St. Louis, Missouri, United States, 63110 | |||||
| United States, Washington | |||||
| Children's Hospital and Regional Medical Center | |||||
| Seattle, Washington, United States, 98105 | |||||
| Principal Investigator: | Matthew Speltz | Children's Hospital and Regional Medical Center |
| Principal Investigator: | Matthew Speltz | Children's Hospital and Regional Medical Center |
More Information
| Study ID Numbers: | NIDCR-13813 |
| First Received: | February 12, 2004 |
| Last Updated: | May 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00077831 |
| Health Authority: | United States: Federal Government |
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