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Active, not recruitingNCT07465055MEROXUpdated Mar 11, 2026

Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele

An observational study in Myelomeningocele, Extubation Time and Neonatal, sponsored by Gaziantep City Hospital. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Gaziantep City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
0 Days to 28 Days
Sex
All
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Study summary

Meningomyelocele is one of the most common neural tube defects requiring surgical repair in the neonatal period. Postoperative respiratory complications and the need for prolonged mechanical ventilation are important causes of morbidity in these patients. The timing of extubation may influence postoperative respiratory outcomes and the duration of neonatal intensive care unit (NICU) stay. This retrospective cohort study aims to evaluate the impact of operating room extubation on postoperative outcomes in neonates undergoing meningomyelocele repair at Gaziantep City Hospital. Clinical, laboratory, and perioperative data will be obtained from hospital records. Postoperative mechanical ventilation requirement, duration of ventilation, NICU length of stay, and perioperative laboratory changes will be compared between neonates extubated in the operating room and those extubated in the intensive care unit.

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Conditions studied

  • Myelomeningocele
  • Extubation Time
  • Neonatal

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Keywords

  • Myelomeningocele
  • Neonate
  • Operating Room Extubation
  • NICU Length of Stay
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In context

Meningomyelocele

56 studies on the registry are indexed under Meningomyelocele; 14 are open to participants now.

This study's planned enrollment of 60 is above the median of 30 across 17 observational studies indexed under Meningomyelocele.

Browse Meningomyelocele studies →

Lead sponsor

Gaziantep City Hospital is the lead sponsor of 21 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Days to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Operating Room Extubation

    Neonates who were extubated in the operating room immediately after meningomyelocele repair.

  • ICU Extubation

    Neonates who were transferred intubated to the NICU and extubated in the intensive care unit after meningomyelocele repair.

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What researchers measure

Primary outcomes

  1. Postoperative Mechanical Ventilation Requirement

    Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.

    Time frame: Within the first 48 hours after surgery

Secondary outcomes

  1. Length of NICU Stay

    Duration of stay in the neonatal intensive care unit following meningomyelocele repair.

    Time frame: From surgery until discharge from the neonatal intensive care unit, up to 30 days

  2. Change in Blood pH

    Difference between preoperative and postoperative blood pH values.

    Time frame: Preoperative vs postoperative 24 hours

  3. Change in Lactate Level

    Difference between preoperative and postoperative blood lactate levels.

    Time frame: Baseline (preoperative) and 24 hours after surgery

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Study locations

1 site
  • Gaziantep City Hospital
    Gaziantep, Gaziantep 27000, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07465055
Lead sponsor
Gaziantep City Hospital
Responsible party
Recep Karakaşoğlu (Specialist in Anesthesiology and Reanimation, Gaziantep City Hospital) — Principal investigator
First posted
Mar 11, 2026
Start date
Nov 1, 2023
Primary completion
Mar 1, 2026
Completion
May 20, 2026 (estimated)
Last update
Mar 11, 2026

Study contacts

Recep Karakaşoğlu, MD
principal investigator · Gaziantep City Hospital
Sinan Ünsal, MD
study chair · Gaziantep City Hospital
Burak C. Balık, MD
study director · Gaziantep City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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