Completed
CILP

Neurobehavioral Correlates of Craniosynostosis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Congenital Abnormalities
+6

+ Bone Diseases
+ Bone Diseases, Developmental
From 2 Months to 7 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: September 2001
See protocol details

Summary

Principal SponsorSeattle Children's Hospital
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2001Actual date on which the first participant was enrolled.

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.

Official TitleNeurobehavioral Correlates of Craniosynostosis 
NCT00077831
Principal SponsorSeattle Children's Hospital
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
535 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Case-Control
These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 Months to 7 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Congenital Abnormalities
Bone Diseases
Bone Diseases, Developmental
Craniosynostoses
Dysostoses
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Synostosis
Craniofacial Abnormalities
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
Children's Health Care of AtlantaAtlanta, United StatesSee the location
Suspended
Northwestern University, Cleft Lip and Palate InstituteWestchester, United States
Suspended
St. Louis Children's Hospital / Washington UniversitySt. Louis, United States
Suspended
Seattle Children's HospitalSeattle, United States
Completed4 Study Centers
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