A randomised controlled trial of nitric oxide administration during cardiopulmonary bypass in neonates undergoing Arterial Switch Operation for repair of transposition of the great arteries.

Not Applicable

Recruiting

• Conditions: congenital heart disease; transposition of the great arteries; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12618000089235
• Lead Sponsor: Christopher James

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-19
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

•Neonate diagnosed with TGA requiring Arterial Switch Operation
•Consent of parents/guardian.

Exclusion Criteria

•Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of drugs involved in the NO pathway, such as nitro-glycerine, sildenafil
•Requirement for ECLS prior to surgery
•Concurrent viral or bacterial acute or chronic infection, including pulmonary conditions such as pneumonia
•Pre-operative acute respiratory distress syndrome
•Cardiac arrest prior to surgery
•Prior surgical exposure to cardio-pulmonary bypass

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary outcome: Incidence of post-operative: cardiac arrest, delayed sternal closure, need for extracorporeal membranous oxygenation (ECMO), or death.[Hospital discharge]

Secondary Outcome Measures

Name	Time	Method
ength of stay in ICU as assessed from review of the medical records[date of discharge from PICU];length of hospital stay as assessed from review of the medical records [hospital discharge date];ventilator free days as assessed from review of the medical records[date of discharge from PICU];inotrope free days as assessed from review of the medical records [date of discharge from PICU];nitric oxide free days as assessed from review of the medical records[date of discharge from PICU];dialysis free days as assessed from review of the medical records[date of discharge from PICU];ECMO free days as assessed from review of the medical records [date of discharge from PICU];days with open sternum as assessed from review of the medical records [date of discharge from PICU]