Clinical trial NCT06079034: Impact of Cannulation Strategy on Neurologic Injury in Infants With Respiratory Failure
Official title: Impact of Cannulation Strategy on the Rate of Neurologic Injury in Infants With Respiratory Failure: A Propensity Score Analysis of the ELSO Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Keywords: ECMO
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 5058
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients reported to the ELSO registry weighing less than or equal to 10 kilograms at the start of ECMO receiving ECMO for pulmonary support

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurologic Injury
timeFrame: during critical illness supported by ECLS up to 14 days after ECLS stop time
Secondary outcomes:
measure: Mortality
timeFrame: through study completion (ECLS hospital discharge), an average of 2 months
measure: Duration of ECMO support
timeFrame: during the procedure (ECLS support)
measure: Discharge Disposition
timeFrame: through study completion (ECLS hospital discharge), an average of 2 months
measure: Individual neurologic injury
timeFrame: during the procedure (ECLS support), and up to 14 days days after ECLS stop time
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joseph G Kohne
role: PRINCIPAL_INVESTIGATOR
References: