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NCT04251806 · ClinicalTrials.gov registry record
Sleep-disordered Breathing in Infants With Myelomeningocele
A clinical trial of Sleep Disordered Breathing and Myelomeningocele, sponsored by University of Michigan.
- Active
- Registry status
- 173
- Enrollment target
- 9
- Study locations
NCT04251806: Active study of Sleep Disordered Breathing and Myelomeningocele, sponsored by University of Michigan.
NCT04251806 is a study of Sleep Disordered Breathing and Myelomeningocele that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 173 participants, roughly in line with the 189-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target. The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04251806, a study of Sleep Disordered Breathing and Myelomeningocele, is active but no longer recruiting, sponsored by University of Michigan.
- ACTIVE NOT RECRUITING
- Registry status
- 173 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study aims to determine whether the risk for sleep-disordered breathing in infants with myelomeningocele (a severe form of spina bifida) differs among those who underwent fetal vs. postnatal surgery, and to examine the link between sleep-disordered breathing and neurodevelopment.
Primary Outcome
Neonatal sleep studies will be used to capture neonatal Apnea-Hypopnea Index (AHI), the most widely accepted summary measure of sleep-disordered breathing severity for newborns who had fetal (prenatal) versus postnatal myelomeningocele repair.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST neonatal polysomnography
- DIAGNOSTIC_TEST 2-year Bayley Exam
- DIAGNOSTIC_TEST 2-year polysomnography
Study Locations (9)
Minnesota
- Children's Minnesota - Minneapolis
- Mayo Clinic - Rochester
Alabama
- University of Alabama at Birmingham - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
Michigan
- Mott Children's Hospital - Ann Arbor
Missouri
- Washington University - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Texas
- University of Texas-Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2026-07 |
What the registry record for NCT04251806 still lists
NCT04251806 is an observational study that tracks outcomes without assigning an intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 189-participant average among 19 other Sleep Disordered Breathing trials with a reported enrollment target.
The record links to 2 conditions, with Sleep Disordered Breathing appearing as the primary indexed condition, and to 3 interventions - of which neonatal polysomnography is the first listed.
NCT04251806 lists 9 locations in 8 states (Minnesota, Alabama, Colorado).
Frequently Asked Questions
What is clinical trial NCT04251806 about?
NCT04251806 is a clinical study titled "Sleep-disordered Breathing in Infants With Myelomeningocele". This study aims to determine whether the risk for sleep-disordered breathing in infants with myelomeningocele (a severe form of spina bifida) differs among those who underwent fetal vs. postnatal surgery, and to examine the link between sleep-disordered breathing and neurodevelopment.
What is the current status of trial NCT04251806?
This trial is currently active not recruiting. The enrollment target is 173 participants. The study started on 2020-07-21. Estimated completion is 2026-07.
What conditions does trial NCT04251806 study?
This clinical trial studies the following conditions: Sleep Disordered Breathing, Myelomeningocele.
What interventions are being tested in trial NCT04251806?
The interventions under investigation include: neonatal polysomnography (DIAGNOSTIC_TEST), 2-year Bayley Exam (DIAGNOSTIC_TEST), 2-year polysomnography (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04251806?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04251806 being conducted?
This trial has 9 study locations across Alabama, Colorado, Michigan, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Disordered Breathing
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04251806's enrollment target sits among peer trials
173 5th of 19 higher than 15 of 19 other Sleep Disordered Breathing trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disordered Breathing 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.
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