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NCT Number: NCT07793812

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

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.

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Key information

Age range

0 month–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Bahçeşehir University Göztepe Medical Park Hospital Complex

Istanbul, Kadıköy, 34732, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical Procedures

Procedure

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

Other names: neonatal surgery

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ayberk Ozkavakli

Other

Registry information

Official study title

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

Acronym: NeoSurg-Resp

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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