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Preoperative Characteristics and Outcomes of Neonates Undergoing Surgical Procedures in the NICU

Preoperative Factors Associated With Prolonged Postoperative Mechanical Ventilation in Neonates Undergoing Surgery: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07793812
Acronym
NeoSurg-Resp
Enrollment
183
Registered
2026-08-31
Start date
2026-08-13
Completion date
2026-08-26
Last updated
2026-08-31

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

Conditions

Mechanical Ventilation, Surgeries Undergoing General Anesthesia

Keywords

mechanical ventilation, prolonged ventilation, nicu, surgery, post operative ventilation, preoperative factors

Brief 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. 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.

Interventions

PROCEDURESurgical Procedures

Surgical procedures performed as part of routine clinical care in neonates hospitalized in the NICU. No intervention was assigned by the investigators.

Sponsors

Ayberk Ozkavakli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Months to 6 Months
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Prolonged Postoperative Invasive Mechanical VentilationFrom surgery until 7 days after surgeryProlonged postoperative invasive mechanical ventilation was defined as the requirement for invasive mechanical ventilation for more than 7 days following surgery.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026