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Completed

NCT Number: NCT00077831

Child and Infant Learning Project

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

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Key information

Conditions

Craniosynostosis Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

2 month–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Health Care of Atlanta, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

neurobehavioral development

Behavioral

observational study of infant and child development

Primary outcomes

  1. 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

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

    Time frame: Target age 7 years

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Neurobehavioral Correlates of Craniosynostosis

Acronym: CILP

Important dates

Study start
2001
Primary completion
2014
Study completion
2015
First posted
Feb 16, 2004
Registry last updated
Jul 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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