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Home > "I" Clinical Trials Conditions > Infant Learning Project  Infant Learning Project
Infant Learning Project
For Condition: Craniosynostosis
Status: Recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: To learn more about the cognitive and motor development of babies born with a craniofacial birth defect called craniosynostosis.
Details: 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:
Study Type: Observational, Natural History, Longitudinal, Case Control, Prospective Study
Minimum Age/Maximum Age: 2 Months/3 Years
Genders: Both
Protocol Entry 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).
Total Enrollment: 500
Location and Contact Information:
Children's Hospital and Regional Medical Center *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Matthew Speltz 206-368-4949
St. Louis Children's Hospital Washingtin University *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Matthew Speltz 206-368-4949
Children's Health Care of Atlanta *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Matthew Speltz 206-368-4949
Northwestern University, Cleft Lip and Palate Institute *Recruiting*
Westchester, Illinois, 60154
United States
Recruiting Matthew Speltz 206-368-4949
Additional Information:
Study ID Numbers: NIDCR-13813;
Study Start Date: September 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077831
Other Craniosynostosis Studies:
1. Infant Learning Project
Related Studies:
Other Craniosynostosis Clinical Trials
Other Georgia Clinical Trials
Other Atlanta Clinical Trials
Infant Learning Project
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