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

Conditions

None listed

Brief summary

This pilot pragmatic open label randomized controlled Trial (RCT) compares the use of Nitric Oxide (NO) treatment blended into the oxygenator of the Extracorporeal Membrane Oxygenation (ECMO) circuit in comparison to standard care defined as no treatment with NO into the ECMO circuit. We hypothesize that in children treated with ECMO, a randomized trial investigating the use of NO during ECMO is feasible. We hypothesize that neonates and children on ECMO exposed to NO on ECMO have a reduced rate of clotting and bleeding complication and reduced inflammatory response measured by various clotting markers as well as serum cytokine levels in comparison to controls, leading to shorter ECMO run duration and reduced health care costs. The findings could have major potential to improve patient-centered outcomes and reduce health care costs.

Mattke AC, Johnson K, Gibbons K, Le Marsney R, Long DA, O'Brien C, Blumenthal A, Venugopal PS, Alphonso N, Schlapbach LJ.

2026-03-11

10.1097/pcc.0000000000003926

Nitric Oxide on Extracorporeal Membrane Oxygenation in Neonates and Children (NECTAR Trial): Protocol for a Randomized Controlled Trial

Adrian Mattke, Kerry Johnson, Kristen Gibbons, Debbie Long, Jeremy Robertson et al. (9 authors)

JMIR Research Protocols2023-01-285 citations

10.2196/43760

Interventions

Patients allocated to the study gas arm will receive nitric oxide (NO), which will be blended into the fresh gas flow for the ECMO oxygenator and maintained at 20 ppm. ECMO specialists and/or Perfusionists will administer the study drug via a Nitric Oxide delivery system (such as SoKinox provided by Air Liquide Healthcare) with continuous sampling of NO and NO2 concentration from an access port just prior to the oxygenator. NO will be started when the patient is cannulated for ECMO and ceased

Patients allocated to the study gas arm will receive nitric oxide (NO), which will be blended into the fresh gas flow for the ECMO oxygenator and maintained at 20 ppm. ECMO specialists and/or Perfusionists will administer the study drug via a Nitric Oxide delivery system (such as SoKinox provided by Air Liquide Healthcare) with continuous sampling of NO and NO2 concentration from an access port just prior to the oxygenator. NO will be started when the patient is cannulated for ECMO and ceased once patient is off ECMO. The duration of the intervention should be equal to the duration of ECMO (i.e. several days). ECMO specialists and/or Perfusionists will record electronically the start time and stop time of the study drug. Patients allocated to the intervention arm will receive standard respiratory gases (oxygen-air mix) during ECMO as per institutional practice. Compliance with protocol will be assessed through the prospective institutional drug charts, and the prospective study case report form.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 17 Years

Healthy volunteers

No

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

Outcome results