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NCT04072783 · ClinicalTrials.gov registry record · NA
Neurodevelopmental Outcomes in Craniosynostosis Repair
A NA study, sponsored by University of Arkansas.
- Terminated
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT04072783: Clinical Trial NA study, sponsored by University of Arkansas.
NCT04072783 is a NA study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04072783, a NA study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
Context: Craniosynostosis is a common craniofacial abnormality which can be associated with various clinical syndromes. Though it has been established that children with craniosynostosis score lower on certain developmental tests, the effect of craniosynostosis and cranioplasty surgery on the neural circuitry and brain development is less well known or understood. Objectives: The purpose of this study is to describe the effect of cranial vault remodeling in children with craniosynostosis on white matter tracts with tractography and Diffusion tensor imaging (DTI), functional MRI, and neurodevelopmental tests, before and after surgery as compared to age-matched controls. Study Design: This will be a prospective study of patients diagnosed with craniosynostosis and who are going to have open or endoscopic cranial vault remodeling (CVR). Study Measures: The study will measure MRI sequences before and after surgery and at set time intervals to quantify the effect of white matter tract maturity. Parallel to this, neurodevelopmental tests will be administered at these same intervals.
Primary Outcome
Will establish pilot data to establish a normative curve of white-matter tract development in normal children under 4 years of age using (DTI). Fractional anisotropy (FA) (a main DTI parameter sensitive to white matter integrity) maps will be created to achieve a normative "white matter change curve" with from infancy to pre-school age.
Interventions
- DIAGNOSTIC_TEST MRI,DTI, functional MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
Why NCT04072783 stopped before completion
NCT04072783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which MRI,DTI, functional MRI is the first listed.
NCT04072783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04072783 about?
NCT04072783 is a clinical study titled "Neurodevelopmental Outcomes in Craniosynostosis Repair". Context: Craniosynostosis is a common craniofacial abnormality which can be associated with various clinical syndromes. Though it has been established that children with craniosynostosis score lower on certain developmental tests, the effect of craniosynostosis and cranioplasty surgery on the neural...
What is the current status of trial NCT04072783?
This trial is currently terminated. It is a NA study. The enrollment target is 9 participants. The study started on 2021-07-08. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT04072783?
The interventions under investigation include: MRI,DTI, functional MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04072783?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04072783's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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