Child and Infant Learning Project - Full Text View

Sponsor:	Seattle Children's Hospital
Collaborator:	National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:	Seattle Children's Hospital
ClinicalTrials.gov Identifier:	NCT00077831

Purpose

To learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.

Condition	Intervention
Craniosynostosis	Behavioral: neurobehavioral development

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Neurobehavioral Correlates of Craniosynostosis

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Seattle Children's Hospital:

Enrollment:	535
Study Start Date:	September 2001
Estimated Study Completion Date:	June 2013

Intervention Details:

observational study of infant and child development

Detailed Description:

In the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal. A case-matched "control" group of healthy, normal infants was also followed. This study, which is now in its second phase, is following this same cohort of children at the age of 7 years.

Eligibility

Ages Eligible for Study:	2 Months to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children with single-suture craniosynostosis between the ages of 2 months and 3 years were recruited and followed during phase 1. This same chort of children are now being followed at the age of 7 (phase 2). See eligibility criteria section for more information.

Criteria

Enrollment criteria at Phase 1:

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/significant health problems
33 months or younger at time of enrollment (male or female).

Enrollment criteria at Phase 2:

All participants enrolled in phase 1 are invited to participate in phase 2.

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 / Washington University
St. Louis, Missouri, United States, 63110
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Seattle Children's Hospital

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:

Matthew L. Speltz

Seattle Children's Hospital

More Information

Publications:

Starr JR, Kapp-Simon KA, Cloonan YK, Collett BR, Cradock MM, Buono L, Cunningham ML, Speltz ML. Presurgical and postsurgical assessment of the neurodevelopment of infants with single-suture craniosynostosis: comparison with controls. J Neurosurg. 2007 Aug;107(2 Suppl):103-10.

Lin HJ, Ruiz-Correa S, Shapiro LG, Speltz ML, Cunningham ML, Sze RW. Predicting neuropsychological development from skull imaging. Conf Proc IEEE Eng Med Biol Soc. 2006;1:3450-5.

Ruiz-Correa S, Starr JR, Lin HJ, Kapp-Simon KA, Cunningham ML, Speltz ML. Severity of skull malformation is unrelated to presurgery neurobehavioral status of infants with sagittal synostosis. Cleft Palate Craniofac J. 2007 Sep;44(5):548-54.

Toth K, Collett B, Kapp-Simon KA, Cloonan YK, Gaither R, Cradock MM, Buono L, Cunningham ML, Dawson G, Starr J, Speltz ML. Memory and Response Inhibition in Young Children with Single-Suture Craniosynostosis. Child Neuropsychol. 2007 Sep 26;:1-14 [Epub ahead of print]

Kapp-Simon KA, Speltz ML, Cunningham ML, Patel PK, Tomita T. Neurodevelopment of children with single suture craniosynostosis: a review. Childs Nerv Syst. 2007 Mar;23(3):269-81. Epub 2006 Dec 21. Review.

Kapp-Simon KA, Leroux B, Cunningham M, Speltz ML. Multisite study of infants with single-suture craniosynostosis: preliminary report of presurgery development. Cleft Palate Craniofac J. 2005 Jul;42(4):377-84.

Speltz ML, Kapp-Simon KA, Cunningham M, Marsh J, Dawson G. Single-suture craniosynostosis: a review of neurobehavioral research and theory. J Pediatr Psychol. 2004 Dec;29(8):651-68. Review.

Ruiz-Correa S, Sze RW, Starr JR, Lin HT, Speltz ML, Cunningham ML, Hing AV. New scaphocephaly severity indices of sagittal craniosynostosis: a comparative study with cranial index quantifications. Cleft Palate Craniofac J. 2006 Mar;43(2):211-21.

Responsible Party:	Matthew L. Speltz, Principal Investigator, Seattle Children's
ClinicalTrials.gov Identifier:	NCT00077831 History of Changes
Other Study ID Numbers:	NIDCR-13813, R01DE013813
Study First Received:	February 12, 2004
Last Updated:	January 6, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases

Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Plagiocephaly
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 12, 2012