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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
Study 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 January 15, 2009