Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele (NCT07465055) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele
Turkey (Türkiye)60 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range
0 Days – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Mechanical Ventilation Requirement
Timeframe: Within the first 48 hours after surgery