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Fetal vs. postnatal surgery: which leads to better sleep breathing for spina bifida babies?

NCT ID NCT04251806

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

173 people

The number who actually took part.

Started

Jul 2020

Finished

May 2026

Lead sponsor

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

Up to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Texas-Houston

    Houston, Texas, 77030, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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