Full Text View
Tabular View
No Study Results Posted
Related Studies
Infant Learning Project
This study is ongoing, but not recruiting participants.
Study NCT00077831   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: February 12, 2004   Last Updated: May 24, 2007   History of Changes

February 12, 2004
May 24, 2007
September 2001
 
 
 
Complete list of historical versions of study NCT00077831 on ClinicalTrials.gov Archive Site
 
 
 
Infant Learning Project
Neurobehavioral Correlates of Neurobehavioral Correlates of Craniosynostosis

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

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.

 
Observational
Natural History, Longitudinal, Case Control, Prospective Study
Craniosynostosis
Behavioral: neurobehavioral development
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
500
May 2007
 
  • 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).
Both
2 Months to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077831
 
NIDCR-13813
National Institute of Dental and Craniofacial Research (NIDCR)
 
Principal Investigator: Matthew Speltz Children's Hospital and Regional Medical Center
Principal Investigator: Matthew Speltz Children's Hospital and Regional Medical Center
National Institute of Dental and Craniofacial Research (NIDCR)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP