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Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00077831 |
To learn more about the cognitive and motor development of babies born with a craniofacial birth defect called craniosynostosis.
Condition | Intervention |
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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.
Ages Eligible for Study: | 2 Months to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 |
Study ID Numbers: | NIDCR-13813 |
Study First Received: | February 12, 2004 |
Last Updated: | May 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00077831 |
Health Authority: | United States: Federal Government |
Craniosynostoses Musculoskeletal Diseases Craniofacial Abnormalities Bone Diseases, Developmental |
Craniosynostosis Congenital Abnormalities Bone Diseases Musculoskeletal Abnormalities |
Synostosis Dysostoses |