ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development).

  • Barbaro, Ryan (Primary Chief Investigator (PCI))
  • Hodgson, Carol (Chief Investigator (CI))

Project: Research

Project Details

Project Description

We therefore propose ASCEND (ARDS in Children and ECMO initiation strategies impact on Neuro-Development), which will measure long-term functional status in children receiving ECMO from centers capable of providing maximal conventional therapies (Aim 1). Sites will be selected from the 400-site Extracorporeal Life Support Organization (ELSO) Registry, an international ECMO registry chaired by PI Barbaro, that records mechanical ventilator pressures when intensivists initiate ECMO. ELSO does not currently measure long-term functional outcomes. We will prospectively follow up with 500 ECMO supported children with severe PARDS, filling this critical knowledge gap in PARDS treatment.
These children will then serve as a control group, to be compared to a treatment group of subjects enrolled in the NHLBI supported Prone and Oscillation Pediatric Clinical Trial (PROSpect) (Aim 2). PROSpect is an international two-by-two factorial, response-adaptive, randomized, controlled clinical trial of supine/prone positioning and conventional mechanical ventilation/high-frequency oscillatory ventilation in children with severe PARDS. Approximately 50 pediatric intensive care units (PICUs) are participating. All participating PICUs have at least 5 years of experience in the study interventions, and they are able to provide back-up ECMO support for failed treatment assignment. PROSpect reserves ECMO until PROSpect protocol failure. Thus, all PROSpect enrolled children have protocolized ECMO candidacy. Once enrolled in PROSpect, some patients will continue on to ECMO initiation while others will not.
ASCEND will use comparative effectiveness methods to compare children in the control group (subjects from the ELSO registry: typical practice ECMO initiation) to children in the treatment group (all PROSpect subjects: protocolized ECMO candidacy). ASCEND will harmonize ELSO and PROSpect data collection on physiology, trajectory, and long-term outcomes. ASCEND will then use advanced statistical matching to mimic an intention-to-treat design with observational data by comparing equally critically ill patients treated under typical practice ECMO initiation (ELSO) and protocolized ECMO candidacy (PROSpect enrollees), addressing the knowledge gap around the consequences of ECMO initiation timing.
Short titleASCEND
Effective start/end date5/09/2030/06/25