itric Oxide on ExtraCorporeal Membrane Oxygenation – a randomised Trial in neonates and children (NECTAR trial).

Not Applicable

• Conditions: Cardiovascular failure requiring Extracorporeal Membrane Oxygenation; Respiratory failure requiring Extracorporeal Membrane Oxygenation; Respiratory - Other respiratory disorders / diseases; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12619001518156
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-04
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. All neonates and children < 18 years requiring ECMO for respiratory or cardiovascular dysfunction including extracorporeal cardiopulmonary resuscitation (eCPR)
2. Ability to obtain prospective consent or consent to continue from parents/guardian.

Exclusion Criteria

1. Patients retrieved to PICU on ECMO who did not undergo randomisation during cannulation
2. Pre-existing methaemoglobinemia (MetHb>3%)
3. Anticipated inability to obtain parental consent (prospective consent or consent to continue)
4. Patients managed on ventricular assist device (VAD) only without an oxygenator present in the ECMO circuit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main feasibility outcome is compliance with study protocol during the pilot.<br><br>We will assess the prospective hospital charts (including electronic health records and paper-based charts) and the study case report form to assess compliance with the study protocol.[30 days after randomisation.];The primary outcome is defined as survival free of ECMO, censored at 90 days post randomisation. Patients dying within 90 days of presentation will be considered as zero days to correct for the competing effect of mortality on ECMO free survival. <br><br>We will access the prospective hospital charts (including electronic health records and paper-based charts) and the study case report form to assess ECMO use and survival status.[90 days after randomisation.]