Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele

NCT07465055 | Active Not Recruiting

• 1 other identifier: Gazianestreamenex
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelomeningocele; Extubation Time; Neonatal

Keywords

Myelomeningocele; Neonate; Operating Room Extubation; NICU Length of Stay

Outcome Measures

Primary Outcomes (1)

• Postoperative Mechanical Ventilation Requirement

  Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.

  Within the first 48 hours after surgery

Secondary Outcomes (3)

• Length of NICU Stay

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

• Change in Blood pH

  Preoperative vs postoperative 24 hours

• Change in Lactate Level

  Baseline (preoperative) and 24 hours after surgery

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Gaziantep City Hospital

Gaziantep, Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Meningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Recep Karakaşoğlu, MD

  Gaziantep City Hospital

  PRINCIPAL INVESTIGATOR

• Sinan Ünsal, MD

  Gaziantep City Hospital

  STUDY CHAIR

• Burak C. Balık, MD

  Gaziantep City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 11, 2026
• Study Start: November 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: May 20, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)