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ACTIVE NOT RECRUITING

Sleep-disordered Breathing in Infants With Myelomeningocele

NCT04251806 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 173 participants
Start Date 2020-07-21
Est. Completion 2026-07

Sponsor

University of Michigan

1,126 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04251806

The ClinicalTrials.gov registry entry for NCT04251806 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Myelomeningocele appearing as the primary indexed condition, and to 3 interventions — of which neonatal polysomnography is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04251806 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Minnesota, Alabama, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Myelomeningocele, Sleep-disordered Breathing. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04251806?

This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial