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Timing of breathing tube removal may impact newborn spina bifida recovery

NCT ID NCT07465055

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study examines whether removing the breathing tube (extubation) in the operating room versus later in the intensive care unit improves outcomes for newborns undergoing surgery for myelomeningocele, a type of spina bifida. Researchers will review records of 60 babies to compare breathing support needs and hospital stay length. The goal is to find the best timing to reduce complications and shorten NICU stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors decide the best time to remove breathing tubes after surgery, potentially reducing time in the intensive care unit for newborns with spina bifida.
What could go wrong
This is a small, retrospective study (looking back at past records) with only 60 patients, so results may not apply to all newborns. It cannot prove cause and effect.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

May 2026

An estimate. End dates often move.

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

Neonates who underwent meningomyelocele repair under general anesthesia at Gaziantep City Hospital between November 2023 and March 2026. All patients were followed postoperatively in the neonatal intensive care unit, and perioperative clinical and laboratory data were obtained from hospital medical records.

Ages

0 to 28 days

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 undergoing surgical repair of meningomyelocele * Surgery performed under general anesthesia * Age ≤ 28 days at the time of surgery * Postoperative follow-up in the neonatal intensive care unit (NICU) * Availability of complete perioperative clinical and laboratory data Exclusion Criteria: * Preoperative respiratory distress requiring invasive or non-invasive ventilatory support * Major congenital anomalies or severe comorbidities (e.g., complex congenital heart disease, severe pulmonary disease, chromosomal abnormalities) * Neonates with poor postnatal adaptation (5-minute Apgar score \< 7) * Preoperative hemodynamic instability * Severe prematurity-related respiratory morbidity * Prolonged mechanical ventilation due to causes unrelated to meningomyelocele surgery * Incomplete or missing perioperative medical records

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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

  • Gaziantep City Hospital

    Gaziantep, Gaziantep, 27000, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.