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Child and Infant Learning Project (CILP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077831
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : July 21, 2015
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Matt Speltz, Seattle Children's Hospital

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

Condition or disease Intervention/treatment
Craniosynostosis Behavioral: neurobehavioral 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.

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Study Type : Observational
Actual Enrollment : 535 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Neurobehavioral Correlates of Craniosynostosis
Study Start Date : September 2001
Actual Primary Completion Date : April 2014
Actual Study Completion Date : June 2015

Intervention Details:
  • Behavioral: neurobehavioral development
    observational study of infant and child development

Primary Outcome Measures :
  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 Outcome Measures :
  1. Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV [ Time Frame: Target age 7 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077831

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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
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Matthew L. Speltz Seattle Children's Hospital
Publications of Results:

Other Publications:
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Responsible Party: Matt Speltz, Principal Investigator, Seattle Children's Hospital Identifier: NCT00077831    
Other Study ID Numbers: NIDCR-13813
R01DE013813 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities