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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 12, 2004 | ||||||||
| Last Updated Date | May 24, 2007 | ||||||||
| Start Date ICMJE | September 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00077831 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Infant Learning Project | ||||||||
| Official Title ICMJE | Neurobehavioral Correlates of Neurobehavioral Correlates of Craniosynostosis | ||||||||
| Brief Summary | To learn more about the cognitive and motor development of babies born with a craniofacial birth defect called craniosynostosis. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Natural History, Longitudinal, Case Control, Prospective Study | ||||||||
| Condition ICMJE | Craniosynostosis | ||||||||
| Intervention ICMJE | Behavioral: neurobehavioral development | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | May 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||||||
| Ages | 2 Months to 3 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00077831 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | NIDCR-13813 | ||||||||
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||
| Verification Date | May 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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