MyelomeningoceleMEROXNCT07465055
Operating Room Extubation and Postoperative Outcomes in Neonates With Meningomyelocele
An observational study of Myelomeningocele and Extubation Time, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Myelomeningocele, Extubation Time, Neonatal
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 20 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep City Hospital
Gaziantep, Gaziantep, 27000
About this study
Official title: 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.
- Conditions
- Myelomeningocele, Extubation Time, Neonatal
- Keywords
- Myelomeningocele, Neonate, Operating Room Extubation, NICU Length of Stay
- Medical subject headings
- Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Mechanical Ventilation Requirement
Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.
Measured: Within the first 48 hours after surgery
Secondary outcomes (3)
Length of NICU Stay
Duration of stay in the neonatal intensive care unit following meningomyelocele repair.
Measured: 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.
Measured: Preoperative vs postoperative 24 hours
Change in Lactate Level
Difference between preoperative and postoperative blood lactate levels.
Measured: Baseline (preoperative) and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Nov 2023
- Primary completion1 Mar 2026
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomeningoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Karakaşoğlu, Gaziantep City Hospital
- Investigators
- Recep Karakaşoğlu, MD, Principal investigator, Gaziantep City HospitalSinan Ünsal, MD, Study chair, Gaziantep City HospitalBurak C. Balık, MD, Study director, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465055
- Sponsor's protocol ID
- Gazianestreamenex
- Acronym
- MEROX
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Operating Room Extubation on Postoperative Outcomes in Neonates Undergoing Meningomyelocele Repair: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07465055
- Acronym / sponsor ID
- MEROX / Gazianestreamenex
- Conditions
- Myelomeningocele, Extubation Time, Neonatal
- Keywords
- Myelomeningocele, Neonate, Operating Room Extubation, NICU Length of Stay
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Mechanical Ventilation Requirement
Time frame: Within the first 48 hours after surgery
Requirement for invasive mechanical ventilation after meningomyelocele repair in neonates.
3 secondary outcomes
Length of NICU Stay
Time frame: From surgery until discharge from the neonatal intensive care unit, up to 30 days
Change in Blood pH
Time frame: Preoperative vs postoperative 24 hours
Change in Lactate Level
Time frame: Baseline (preoperative) and 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Myelomeningocele
Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Active, not recruitingPhase 1
Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study
Neural Tube Defects
Recruiting
Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects
Spina Bifida
Recruiting
tSCS in Children With Spina Bifida
Spina Bifida, Myelomeningocele
Active, not recruiting
Fetoscopic NEOX Cord 1K® Spina Bifida Repair
Spina Bifida, Myelomeningocele
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Recep Karakaşoğlu, MD principal investigator
Gaziantep City Hospital
Sinan Ünsal, MD study chair
Gaziantep City Hospital
Burak C. Balık, MD study director
Gaziantep City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelomeningocele and Extubation Time, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Mechanical Ventilation Requirement (time frame: Within the first 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.