Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele (MEROX)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myelomeningocele; Neonatal; Extubation Time

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Gaziantep
    • Gaziantep, Gaziantep, Turkey (Türkiye), 27000
      • Gaziantep City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Mechanical Ventilation Requirement	Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.	Within the first 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of NICU Stay	Duration of stay in the neonatal intensive care unit following meningomyelocele repair.	From surgery until discharge from the neonatal intensive care unit, up to 30 days
Change in Blood pH	Difference between preoperative and postoperative blood pH values.	Preoperative vs postoperative 24 hours
Change in Lactate Level	Difference between preoperative and postoperative blood lactate levels.	Baseline (preoperative) and 24 hours after surgery

Collaborators and Investigators

• Sponsor: Gaziantep City Hospital
• Investigators: Principal Investigator: Recep Karakaşoğlu, MD, Gaziantep City Hospital; Study Chair: Sinan Ünsal, MD, Gaziantep City Hospital; Study Director: Burak C. Balık, MD, Gaziantep City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): May 20, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 7, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Neonate; Myelomeningocele; Operating Room Extubation; NICU Length of Stay
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Meningomyelocele
• Other Study ID Numbers: Gazianestreamenex

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No