ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Infant Learning Project

This study is ongoing, but not recruiting participants.

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

Genetics Home Reference related topics:   Apert syndrome    Baller-Gerold syndrome    Beare-Stevenson cutis gyrata syndrome    Crouzonodermoskeletal syndrome    Crouzon syndrome    Jackson-Weiss syndrome    Muenke syndrome    Pfeiffer syndrome   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Case Control, Prospective Study
Official Title:   Neurobehavioral Correlates of Neurobehavioral Correlates of Craniosynostosis

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Estimated Enrollment:   500
Study Start Date:   September 2001
Estimated Study Completion Date:   May 2007

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.

  Eligibility
Ages Eligible for Study:   2 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077831

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

Sponsors and Collaborators

Investigators
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

Study placed in the following topic categories:
Craniosynostoses
Musculoskeletal Diseases
Craniofacial Abnormalities
Bone Diseases, Developmental
Craniosynostosis
Congenital Abnormalities
Bone Diseases
Musculoskeletal Abnormalities

Additional relevant MeSH terms:
Synostosis
Dysostoses

ClinicalTrials.gov processed this record on October 07, 2008




Links to all studies - primarily for crawlers