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

NCT07793812 | Completed

• 1 other identifier: NeoSurg-Resp
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Surgeries Undergoing General Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From surgery until 7 days after surgery

Study Arms (2)

1

requiring imv less than 7 days

Procedure: Surgical Procedures

2

requiring imv for 7 days or more

Procedure: Surgical Procedures

Interventions

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.

Also known as: neonatal surgery

1; 2

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ayberk Ozkavakli: lead

Study Sites (1)

Bahçeşehir University Göztepe Medical Park Hospital Complex

Istanbul, Kadıköy, 34732, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatrician

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 13, 2026
• Primary Completion: August 23, 2026
• Study Completion: August 26, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)