An observational study in Craniosynostosis, sponsored by Seattle Children's Hospital. Completed at 4 sites in United States. Open to participants aged 2 Months to 7 Years. Per ClinicalTrials.gov, last updated 2015-07-21.
Sponsored by Seattle Children's Hospital · Observational
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.
51 studies on the registry are indexed under Craniosynostoses; 14 are open to participants now.
This study's enrollment of 535 is above the median of 43 across 26 observational studies indexed under Craniosynostoses.
Browse Craniosynostoses studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Enrollment criteria at Phase 2:
All participants enrolled in phase 1 are invited to participate in phase 2.
observational study of infant and child development
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.
Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV
Time frame: Target age 7 years
The record gives a start of Sep 2001, a primary completion of Apr 2014 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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