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Child and Infant Learning Project (CILP)

Seattle Children's Healthcare System logo

Seattle Children's Healthcare System

Status

Completed

Conditions

Craniosynostosis

Treatments

Behavioral: neurobehavioral development

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00077831
R01DE013813 (U.S. NIH Grant/Contract)
NIDCR-13813

Details and patient eligibility

About

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

Full 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.

Enrollment

535 patients

Sex

All

Ages

2 months to 7 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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