Impact of Cannulation Strategy on Neurologic Injury in Infants With Respiratory Failure

Study Overview
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Brief Summary
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There has been increasing use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. This study seeks to leverage the increased use of VA ECMO in this cohort to enrich an evaluation of the differences in rate of intracranial hemorrhage and ischemic stroke between venovenous (VV) and VA ECMO among infants with respiratory failure where clinicians may choose either strategy. This project is a retrospective review of data in the ELSO registry.

Detailed Description
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From 2019-2021, there was increased use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. The primary aim is to estimate the average effect on the rate of neurologic injury of VA ECMO versus venovenous (VV) among infants with respiratory failure over the period 2013-2018, during which clinicians could choose either cannulation strategy. This causal effect will be estimated using an inverse propensity weighted (IPW) approach. Secondarily, the investigators will project this estimated treatment effect forward into the period 2019-2021. The beginning of this period roughly corresponds to start of increased use of VA ECMO. Under the assumption of a homogenous treatment effect across both study periods, the rate of neurologic injury that would have occurred in 2019-2021 will be estimated, had the rate of VA ECMO not increased relative to pre-2019 levels. The hypothesis is that the results will point to an increased rate of neurologic injury starting in 2019 due to the increased use of VA ECMO.

Official Title
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Impact of Cannulation Strategy on the Rate of Neurologic Injury in Infants With Respiratory Failure: A Propensity Score Analysis of the ELSO Registry

Conditions
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Respiratory Failure

Intervention / Treatment
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* Procedure: Venovenous ECMO
* Procedure: Venoarterial ECMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient weighed less than or equal to 10kg at start of ECMO Pulmonary support was the indication for ECLS Initial cannulation strategy was VV or VA The run occurred during the period 2013-2023 Exclusion Criteria: Patient had CDH Patient was post-cardiotomy Non-conventional initial cannulation strategies were employed, such as Central Cannulation (surrogate for inability to achieve peripheral cannulation) Veno-veno-arterial ECMO Initial cannulation approach reported as other Patient was transported into or out of ELSO center on ECMO support Patient had pre-ECLS Cardiac Arrest Patient did not have subsequent ECMO runs in the ELSO registry

Ages Eligible for Study
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Minimum Age: 0 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venovenous ECMO<br> | Procedure: Venovenous ECMO<br>* Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy<br>|
| Venoarterial ECMO<br> | Procedure: Venoarterial ECMO<br>* Initial support type of venoarterial ECMO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic Injury | The outcome will be the composite occurrence of neurologic injury (ischemic stroke, intracranial hemorrhage, and brain death) that arises during critical illness supported by extracorporeal life support (ECLS) as reported to the Extracorporeal Life Support Organization (ELSO) registry, coded as a 0/1 variable (0 = no occurrence was reported during or after ECMO; 1 = one or more occurrence was reported). | during critical illness supported by ECLS up to 14 days after ECLS stop time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Whether a patient is discharged alive as reported to the ELSO registry | through study completion (ECLS hospital discharge), an average of 2 months | 
| Duration of ECMO support | Hours of ECMO support as reported to the ELSO registry | during the procedure (ECLS support) | 
| Discharge Disposition | Hospital discharge location as reported to the ELSO registry | through study completion (ECLS hospital discharge), an average of 2 months | 
| Individual neurologic injury | For each neurologic injury included in the primary outcome measure, the injury will be assessed individually: proportion of patients with ischemic stroke as defined by the ELSO registry; proportion of patients with intracranial hemorrhage as defined by the ELSO registry; proportion of patients with brain death as defined by the ELSO registry | during the procedure (ECLS support), and up to 14 days days after ECLS stop time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECMO