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Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07465055
Acronym
MEROX
Enrollment
60
Registered
2026-03-11
Start date
2023-11-01
Completion date
2026-05-20
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation Time, Myelomeningocele, Neonatal

Keywords

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

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.

Interventions

None listed

Sponsors

Gaziantep City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Mechanical Ventilation RequirementWithin the first 48 hours after surgeryRequirement for invasive mechanical ventilation after meningomyelocele repair in neonates.

Secondary

MeasureTime frameDescription
Change in Lactate LevelBaseline (preoperative) and 24 hours after surgeryDifference between preoperative and postoperative blood lactate levels.
Length of NICU StayFrom surgery until discharge from the neonatal intensive care unit, up to 30 daysDuration of stay in the neonatal intensive care unit following meningomyelocele repair.
Change in Blood pHPreoperative vs postoperative 24 hoursDifference between preoperative and postoperative blood pH values.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORRecep Karakaşoğlu, MD

Gaziantep City Hospital

STUDY_CHAIRSinan Ünsal, MD

Gaziantep City Hospital

STUDY_DIRECTORBurak C. Balık, MD

Gaziantep City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026