ARDS in Children and ECMO initiation strategies impact on Neuro-Development (ASCEND)
M
Matthew Friedman, MD
Primary Investigator
Enrolling By Invitation
14-17 years
All
Phase
N/A
550 participants needed
1 Location
Brief description of study
We will measure the neurodevelopmental impact incurred by children receiving usual care ECMO for PARDS.
Detailed description of study
ASCEND will use the extracorporeal life support organization (ELSO) Registry to prospectively identify and consent 550 children with severe pediatric acute respiratory distress syndrome (PARDS) who are supported with usual care extracorporeal membrane oxygenation (ECMO) and who are not enrolled in the ongoing trial Prone and Oscillation Pediatric Clinical Trial (PROSpect). PROSpect is a NHLBI-funded (1UG3HL141736) phase 3, two-by-two-factorial, response-adaptive, randomized interventional trial testing whether children with severe PARDS randomized to one of 4 treatment protocols, (1) supine + conventional mechanical ventilator, (2) prone + conventional mechanical ventilator, (3) supine + high frequency oscillatory ventilation, or (4) prone + high frequency oscillatory ventilation, exhibit more ventilator-free days over a 28-day period. Secondary analyses examine long-term outcomes of functional status and quality of life.
ASCEND will train and support data managers to collect new data in the ELSO Registry needed for this study including: hospital factors characterizing a hospital’s ECMO care and child factors such as baseline functioning, illness, trajectory, and medical support. The data will be collected exactly as is done in PROSpect so the data for ELSO’s usual care ECMO cohort and the PROSpect’s protocolized therapies cohort are collected identically. ASCEND investigators will prospectively measure the functional status and health-related quality of life at 1, 3, 6 and 12 months after pediatric intensive care unit (PICU) discharge for children in the ELSO’s usual care ECMO cohort (Aim 1). In ELSO’s usual care ECMO intensivist discretion informs positioning/ventilation and the ECMO initiation threshold. The PROSpect’s protocolized therapy cohort used for the Aim 2 analysis will come from children enrolled in PROSpect. PROSpect’s protocolized therapies consists of both protocolized positioning/ventilation and a protocolized threshold when ECMO can be considered. ASCEND will propensity score match children in ELSO’s usual care ECMO group to equally ill children in the PROSpect’s protocolized therapies group (Aim 2).
Aim 1: We will test the hypotheses that one year after children receive usual care ECMO for PARDS, there will be a decline in long-term functional status and health-related quality of life as well as an increase in the proportion of children receiving respiratory support.
Aim 2: We will test the hypotheses that 90-day mortality, one-year functional status, and one-year health-related quality of life are not equivalent for children with usual care ECMO (in ELSO) and PROSpect protocolized therapies.
children with severe PARDS randomized to one of 4 treatment(1) supine + conventional mechanical ventilator, (2) prone +ventional mechanical ventilator, (3) supine + high frequency oscillatoryventilation, or (4) prone + high frequency oscillatory ventilation, exhibitventilator-free days over a 28-day period. Secondary analyses examine long-term outcomes of functionalus and quality of life.
ASCENDwill train and support data managers to collect new data in the ELSO Registryded for this study including: hospital factors characterizing a hospital’sCMO care and child factors such as baseline functioning, illness,jectory, and medical support. The data will be collected exactly as isdone in PROSpect so the data forLSO’s usual care ECMO cohort and the PROSpect’szed therapies cohort are collected identically. ASCEND investigatorswill prospectively measure the functionalus and health-related quality of life at 1, 3, 6 and 12 months after pediatricve care unit (PICU) discharge for children in the ELSO’susual care ECMO cohort (Aim 1). In ELSO’susual care ECMO intensivist discretion informs positioning/ventilationd the ECMO initiation threshold. The PROSpect’s protocolized therapy cohortused for the Aim 2 analysis will come from children enrolled in PROSpect. PROSpect’s protocolized therapies consists of bothzed positioning/ventilation and a protocolized threshold when ECMObe considered. ASCEND willy score match children in ELSO’s usual care ECMO group to equally ill children in the PROSpect’s protocolized therapies group (Aim 2).
Aim 1: We will test the hypotheses that one yearhildren receive usual care ECMO for PARDS, there will be a decline ing-term functional status and health-related quality of life as well as anhe proportion of children receiving respiratory support.
Aim 2: We will test the hypotheses that 90-dayy, one-year functional status, and one-year health-related quality ofquivalent for children with usual care ECMO(in ELSO) and PROSpect protocolizedherapies.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: AIDS, Riley
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Age: Between 14 Years - 17 Years
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Gender: All
Inclusion Criteria:
- 1. Age at ECMO cannulation2. Post-gestational age at ECMO cannulation3. Duration of Intubation prior to ECLS4. ECMO Support Type5. Presence of at least moderate PARDS (date/time of first qualifying oxygenation index (OI) or oxygen saturation index (OSI) measures, First qualifying PaO2, First qualifying SpO2, First qualifying FIO2, First qualifying mean airway pressure (MAP); if needed date/time of second qualifying OI or OSI measures, Second qualifying PaO2, second qualifying SpO2, Second qualifying FIO2, and second MAP.6. Chest radiograph with bilateral lung disease7. Absence of excluded diagnoses1. Age at ECMO cannulation2. Post-gestational age at ECMO cannulation3. Duration of Intubation prior to ECLS4. ECMO Support Type5. Presence of at least moderate PARDS (date/time of first qualifying oxygenation index (OI) or oxygen saturation index (OSI) measures, First qualifying PaO2, First qualifying SpO2, First qualifying FIO2, First qualifying mean airway pressure (MAP); if needed date/time of second qualifying OI or OSI measures, Second qualifying PaO2, second qualifying SpO2, Second qualifying FIO2, and second MAP.6. Chest radiograph with bilateral lung disease7. Absence of excluded diagnoses
Exclusion Criteria:
- Children will be excluded if they have any of the following at the start of mechanical ventilation: perinatal related lung disease, congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis, respiratory failure explained by cardiac failure or fluid overload, cyanotic heart disease, cardiomyopathy, unilateral lung disease, primary pulmonary hypertension, status asthmaticus, obstructive airway disease (e.g., bronchiolitis or disease states characterized by either: hypercapnia and/or evidence of increased resistance visible on the flow – time scalar, and/or presence of intrinsic positive end expiratory pressure (PEEP)), bronchiolitis obliterans, post Hematopoietic Stem Cell Transplant, post lung transplant, home ventilator (including noninvasive) or home oxygen dependent, neuromuscular respiratory failure, critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass), facial surgery or trauma in previous 15 days, head trauma, intracranial bleeding, unstable spine, femur or pelvic fractures, acute abdominal process/open abdomen, obesity, supported on ECMO, previously enrolled in current study, family/medical team deciding not to provide full support, enrolled in any other critical care interventional clinical trial concurrently and known pregnancy
Updated on
13 Sep 2024.
Study ID: 10106, PICU-UMICH-ASCEND
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