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NCT Number: NCT07465055

Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Myelomeningocele Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Extubation Time Meningomyelocele Neonatal Nervous System Diseases Nervous System Malformations Neural Tube Defects

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziantep City Hospital

Gaziantep, 27000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative Mechanical Ventilation Requirement

    Time frame: Within the first 48 hours after surgery

    Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.

Secondary outcomes

  1. Length of NICU Stay

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

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

  2. Change in Blood pH

    Time frame: Preoperative vs postoperative 24 hours

    Difference between preoperative and postoperative blood pH values.

  3. Change in Lactate Level

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

    Difference between preoperative and postoperative blood lactate levels.

Sponsors and collaborators

Lead sponsor

Gaziantep City Hospital

Other

Registry information

Official study title

Impact of Operating Room Extubation on Postoperative Outcomes in Neonates Undergoing Meningomyelocele Repair: A Retrospective Cohort Study

Acronym: MEROX

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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