Fetal vs. postnatal surgery: which leads to better sleep breathing for spina bifida babies?
NCT ID NCT04251806
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 173 infants with myelomeningocele, a severe form of spina bifida, to see if the timing of their surgery (before or after birth) affects their risk for sleep-disordered breathing. Researchers used sleep studies to measure breathing problems and later checked the children's brain development at age 2. The goal was to understand how surgery timing and sleep breathing relate to long-term development.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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173 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Myelomeningocele is characterized by exposure of the spinal cord through a spinal defect.
- Ages
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Up to 2 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: neonates with myelomeningocele who are cared for at a study center NICU are eligible to participate after myelomeningocele repair. Exclusion Criteria: * born at \<30 weeks gestation * congenital anomalies that would predispose to sleep-disordered breathing (e.g. micrognathia) * confirmed or suspected genetic syndromes that alter developmental outcomes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital Colorado
Aurora, Colorado, 80045, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Children's Minnesota
Minneapolis, Minnesota, 55404, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of Texas-Houston
Houston, Texas, 77030, United States
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Washington University
St Louis, Missouri, 63110, United States
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