Sleep-disordered Breathing in Infants With Myelomeningocele
NCT ID: NCT04251806
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
173 participants
OBSERVATIONAL
2020-07-21
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Evaluation of sleep in neonates who require intensive care is an emerging opportunity with potential for major impact on health and quality of life for affected children. As SDB and abnormal sleep are potentially treatable, early assessment and intervention could become an integral part of a multidisciplinary treatment strategy to optimize long-term medical and neurodevelopmental outcomes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prenatal Repair
This group received prenatal myelomeningocele repair.
neonatal polysomnography
This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
2-year Bayley Exam
This procedure will evaluate neurodevelopmental outcomes.
2-year polysomnography
This procedure will allow the detection of sleep-disordered breathing at 2 years of age.
Postnatal Repair
This group received postnatal myelomeningocele repair.
neonatal polysomnography
This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
2-year Bayley Exam
This procedure will evaluate neurodevelopmental outcomes.
2-year polysomnography
This procedure will allow the detection of sleep-disordered breathing at 2 years of age.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
neonatal polysomnography
This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
2-year Bayley Exam
This procedure will evaluate neurodevelopmental outcomes.
2-year polysomnography
This procedure will allow the detection of sleep-disordered breathing at 2 years of age.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* congenital anomalies that would predispose to sleep-disordered breathing (e.g. micrognathia)
* confirmed or suspected genetic syndromes that alter developmental outcomes
2 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Michigan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Renée Shellhaas, MD
Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Renee A Shellhaas, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas-Houston
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUM00165595
Identifier Type: -
Identifier Source: org_study_id