Child and Infant Learning Project

Seattle Children's Hospital535 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

535

Conditions

Craniosynostosis

Interventions

neurobehavioral developmentBEHAVIORAL

observational study of infant and child development

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (4)

Children's Health Care of Atlanta

Atlanta, Georgia, United States

Northwestern University, Cleft Lip and Palate Institute

Westchester, Illinois, United States

St. Louis Children's Hospital / Washington University

St Louis, Missouri, United States

Seattle Children's Hospital

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV

Time frame: Target age 7 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.