Mechanical VentilationNeoSurg-RespNCT07793812
Preoperative Characteristics and Outcomes of Neonates Undergoing Surgical Procedures in the NICU
An observational study of Mechanical Ventilation and Surgeries Undergoing General Anesthesia, run by Ayberk Ozkavakli at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study evaluates neonates who underwent surgical procedures during admission to a neonatal intensive care unit (NICU). The study aims to investigate the relationship between preoperative clinical characteristics and postoperative respiratory support requirements and clinical outcomes. Read more about this study
- Who is it for?
- Ages 0 to 6 months
- Conditions the study is for
- Mechanical Ventilation, Surgeries Undergoing General Anesthesia
- What is being tested?
- Surgical Procedures
- Type of treatment
- Surgery or procedure
- How many people
- 183 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2026to 26 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonates admitted to a tertiary neonatal intensive care unit (NICU) who underwent at least one surgical procedure during NICU hospitalization within the predefined study period.
Who may be able to join
- Neonates admitted to the neonatal intensive care unit (NICU) during the study period.
- Neonates who underwent at least one surgical procedure during NICU hospitalization.
- Availability of preoperative clinical data, including respiratory support status.
- Availability of postoperative respiratory support and clinical outcome data.
- Availability of sufficient medical records for retrospective evaluation.
Who cannot join
- Patients who did not undergo a surgical procedure during NICU hospitalization.
- Patients with insufficient or incomplete medical records to evaluate preoperative clinical characteristics or postoperative respiratory outcomes.
- Patients who underwent procedures outside the predefined study period.
- Patients transferred to another center before postoperative outcomes could be adequately assessed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahçeşehir University Göztepe Medical Park Hospital Complex
Istanbul, Kadıköy, 34732
About this study
Official title: Preoperative Factors Associated With Prolonged Postoperative Mechanical Ventilation in Neonates Undergoing Surgery: A Retrospective Cohort Study
This retrospective observational study evaluates neonates who underwent surgical procedures during admission to a neonatal intensive care unit (NICU). The study aims to investigate the relationship between preoperative clinical characteristics and postoperative respiratory support requirements and clinical outcomes.
Preoperative characteristics include gestational age, birth weight, need for invasive mechanical ventilation, sepsis, and inotropic support. Postoperative respiratory outcomes include the need for and duration of invasive and non-invasive mechanical ventilation. Changes in selected hematological, renal, and liver function parameters before and after surgery are also evaluated.
The study further examines whether prolonged postoperative invasive mechanical ventilation is associated with clinical outcomes, including length of hospital stay, nutritional support, postoperative complications, and mortality. All data are obtained retrospectively from existing medical records, and no intervention is performed as part of the study.
Read the detailed description
This single-center retrospective observational cohort study includes neonates who underwent surgical procedures during hospitalization in a neonatal intensive care unit (NICU).
Demographic and clinical characteristics, including gestational age, birth weight, sex, age and weight at the time of surgery, were obtained from medical records. Preoperative clinical status was assessed using variables including invasive mechanical ventilation, sepsis, and inotropic support.
Postoperative respiratory course was evaluated according to the requirement and duration of invasive mechanical ventilation (IMV) and non-invasive ventilation. Prolonged postoperative mechanical ventilation was defined as an IMV duration of more than 7 days. Postoperative clinical outcomes, including inotropic support, sepsis, nutritional support, length of hospital stay, need for additional surgical procedures, and mortality, were also evaluated.
Laboratory parameters obtained before and after surgery were compared to assess perioperative changes in hematological, renal, and hepatic parameters. These included complete blood count parameters and routinely measured biochemical markers of renal and liver function.
The primary objective was to evaluate the association between preoperative clinical characteristics and prolonged postoperative invasive mechanical ventilation. Secondary objectives included evaluating perioperative changes in laboratory parameters and examining the relationship between postoperative respiratory support patterns and clinical outcomes.
As this was a retrospective study based exclusively on existing medical records, no study-related intervention or modification of clinical management was performed.
- Being tested
- Surgical Procedures
- Keywords
- mechanical ventilation, prolonged ventilation, nicu, surgery, post operative ventilation, preoperative factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ProceduresProcedure or surgery
Also called neonatal surgery
Surgical procedures performed as part of routine clinical care in neonates hospitalized in the NICU. No intervention was assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| 1 | requiring imv less than 7 days Receives: Procedure: Surgical Procedures | |
| 2 | requiring imv for 7 days or more Receives: Procedure: Surgical Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Postoperative Invasive Mechanical Ventilation
Prolonged postoperative invasive mechanical ventilation was defined as the requirement for invasive mechanical ventilation for more than 7 days following surgery.
Measured: From surgery until 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start13 Aug 2026
- Primary completion23 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies 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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayberk Ozkavakli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayberk Ozkavakli, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793812
- Sponsor's protocol ID
- NeoSurg-Resp
- Acronym
- NeoSurg-Resp
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient confidentiality and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Factors Associated With Prolonged Postoperative Mechanical Ventilation in Neonates Undergoing Surgery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07793812
- Acronym / sponsor ID
- NeoSurg-Resp / NeoSurg-Resp
- Keywords
- mechanical ventilation, prolonged ventilation, nicu, surgery, post operative ventilation, preoperative factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Ayberk OzkavakliUniversity, hospital or other
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 23 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 31 Aug 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.
This retrospective observational study evaluates neonates who underwent surgical procedures during admission to a neonatal intensive care unit (NICU). The study aims to investigate the relationship between preoperative clinical characteristics and postoperative respiratory support requirements and clinical outcomes.
Preoperative characteristics include gestational age, birth weight, need for invasive mechanical ventilation, sepsis, and inotropic support. Postoperative respiratory outcomes include the need for and duration of invasive and non-invasive mechanical ventilation. Changes in selected hematological, renal, and liver function parameters before and after surgery are also evaluated.
The study further examines whether prolonged postoperative invasive mechanical ventilation is associated with clinical outcomes, including length of hospital stay, nutritional support, postoperative complications, and mortality. All data are obtained retrospectively from existing medical records, and no intervention is performed as part of the study.
Detailed description
This single-center retrospective observational cohort study includes neonates who underwent surgical procedures during hospitalization in a neonatal intensive care unit (NICU).
Demographic and clinical characteristics, including gestational age, birth weight, sex, age and weight at the time of surgery, were obtained from medical records. Preoperative clinical status was assessed using variables including invasive mechanical ventilation, sepsis, and inotropic support.
Postoperative respiratory course was evaluated according to the requirement and duration of invasive mechanical ventilation (IMV) and non-invasive ventilation. Prolonged postoperative mechanical ventilation was defined as an IMV duration of more than 7 days. Postoperative clinical outcomes, including inotropic support, sepsis, nutritional support, length of hospital stay, need for additional surgical procedures, and mortality, were also evaluated.
Laboratory parameters obtained before and after surgery were compared to assess perioperative changes in hematological, renal, and hepatic parameters. These included complete blood count parameters and routinely measured biochemical markers of renal and liver function.
The primary objective was to evaluate the association between preoperative clinical characteristics and prolonged postoperative invasive mechanical ventilation. Secondary objectives included evaluating perioperative changes in laboratory parameters and examining the relationship between postoperative respiratory support patterns and clinical outcomes.
As this was a retrospective study based exclusively on existing medical records, no study-related intervention or modification of clinical management was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Surgical Proceduresrequiring imv less than 7 days |
| 2 | – | Procedure: Surgical Proceduresrequiring imv for 7 days or more |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates admitted to a tertiary neonatal intensive care unit (NICU) who underwent at least one surgical procedure during NICU hospitalization within the predefined study period.
Key inclusion criteria (5 listed)
- Neonates admitted to the neonatal intensive care unit (NICU) during the study period.
- Neonates who underwent at least one surgical procedure during NICU hospitalization.
- Availability of preoperative clinical data, including respiratory support status.
- Availability of postoperative respiratory support and clinical outcome data.
- Availability of sufficient medical records for retrospective evaluation.
Key exclusion criteria (4 listed)
- Patients who did not undergo a surgical procedure during NICU hospitalization.
- Patients with insufficient or incomplete medical records to evaluate preoperative clinical characteristics or postoperative respiratory outcomes.
- Patients who underwent procedures outside the predefined study period.
- Patients transferred to another center before postoperative outcomes could be adequately assessed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ProceduresAlso: neonatal surgerySurgical procedures performed as part of routine clinical care in neonates hospitalized in the NICU. No intervention was assigned by the investigators. | Procedure or surgery | 1, 2 |
Primary outcome
Prolonged Postoperative Invasive Mechanical Ventilation
Time frame: From surgery until 7 days after surgery
Prolonged postoperative invasive mechanical ventilation was defined as the requirement for invasive mechanical ventilation for more than 7 days following surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient confidentiality and ethical considerations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical Ventilation and Surgeries Undergoing General Anesthesia, run by Ayberk Ozkavakli 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 4 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: finished, as of the sponsor's last update on 31 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prolonged Postoperative Invasive Mechanical Ventilation (time frame: From surgery until 7 days 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 31 Aug 2026.