Child and Infant Learning Project (CILP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matt Speltz, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00077831
First received: February 12, 2004
Last updated: April 11, 2013
Last verified: April 2013
  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:


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

Primary Outcome Measures:
  • Neurodevelopment as assessed by the Bayley Scales of Infant Development II [ Time Frame: 1st assessment - post diagnosis, pre surgery. 2nd assessment - Target age 18 months. 3rd assessment - Target age 36 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV [ Time Frame: Target age 7 years ] [ Designated as safety issue: No ]

Enrollment: 535
Study Start Date: September 2001
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: neurobehavioral development
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Matthew L. Speltz Seattle Children's Hospital
  More Information

Publications:

Responsible Party: Matt Speltz, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00077831     History of Changes
Other Study ID Numbers: NIDCR-13813, R01DE013813
Study First Received: February 12, 2004
Last Updated: April 11, 2013
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 August 19, 2014