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

February 12, 2004
April 11, 2013
September 2001
September 2014   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00077831 on ClinicalTrials.gov Archive Site
Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV [ Time Frame: Target age 7 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Child and Infant Learning Project
Neurobehavioral Correlates of Craniosynostosis

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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.

Craniosynostosis
Behavioral: neurobehavioral development
observational study of infant and child development
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
535
Not Provided
September 2014   (final data collection date for primary outcome measure)

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.

Both
2 Months to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00077831
NIDCR-13813, R01DE013813
No
Matt Speltz, Seattle Children's Hospital
Seattle Children's Hospital
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Matthew L. Speltz Seattle Children's Hospital
Seattle Children's Hospital
April 2013

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