University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06079034
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.
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All sexes
Observational
Ann Arbor, Michigan, 48109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy
Initial support type of venoarterial ECMO
Time frame: during critical illness supported by ECLS up to 14 days after ECLS stop time
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).
Time frame: through study completion (ECLS hospital discharge), an average of 2 months
Whether a patient is discharged alive as reported to the ELSO registry
Time frame: during the procedure (ECLS support)
Hours of ECMO support as reported to the ELSO registry
Time frame: through study completion (ECLS hospital discharge), an average of 2 months
Hospital discharge location as reported to the ELSO registry
Time frame: during the procedure (ECLS support), and up to 14 days days after ECLS stop time
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
University of Michigan
Other
Impact of Cannulation Strategy on the Rate of Neurologic Injury in Infants With Respiratory Failure: A Propensity Score Analysis of the ELSO Registry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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