Respiratory FailureNCT06079034
Impact of Cannulation Strategy on Neurologic Injury in Infants With Respiratory Failure
An observational study of Respiratory Failure, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Venovenous ECMO and Venoarterial ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 5,058 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2023to 12 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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"
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Failure
- Being tested
- Venovenous ECMO, Venoarterial ECMO
- Keywords
- ECMO
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venovenous ECMOProcedure or surgery
Initial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy
Venoarterial ECMOProcedure or surgery
Initial support type of venoarterial ECMO
| Study group | Role | What they receive |
|---|---|---|
| Venovenous ECMO | Not described Receives: Procedure: Venovenous ECMO | |
| Venoarterial ECMO | Not described Receives: Procedure: Venoarterial ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: during critical illness supported by ECLS up to 14 days after ECLS stop time
Secondary outcomes (4)
Mortality
Whether a patient is discharged alive as reported to the ELSO registry
Measured: 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
Measured: during the procedure (ECLS support)
Discharge Disposition
Hospital discharge location as reported to the ELSO registry
Measured: 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
Measured: during the procedure (ECLS support), and up to 14 days days after ECLS stop time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start18 Oct 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,058 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Kohne (Pediatrics), University of Michigan
- Investigators
- Joseph G Kohne, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079034
- Sponsor's protocol ID
- HUM00236110
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data received from the ELSO Registry is available to qualified researchers through an ELSO data request
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06079034
- Acronym / sponsor ID
- HUM00236110
- Conditions
- Respiratory Failure
- Keywords
- ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,058 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venovenous ECMO | – | Procedure: Venovenous ECMO |
| Venoarterial ECMO | – | Procedure: Venoarterial ECMO |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patient had CDH
- Patient was post-cardiotomy
- Non-conventional initial cannulation strategies were employed, such as
- Patient was transported into or out of ELSO center on ECMO support
- Patient had pre-ECLS Cardiac Arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venovenous ECMOInitial support type of venovenous ECMO via a dual-lumen on two-site VV ECMO cannulation strategy | Procedure or surgery | Venovenous ECMO |
| Venoarterial ECMOInitial support type of venoarterial ECMO | Procedure or surgery | Venoarterial ECMO |
Primary outcome
Neurologic Injury
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).
4 secondary outcomes
Mortality
Time frame: through study completion (ECLS hospital discharge), an average of 2 months
Duration of ECMO support
Time frame: during the procedure (ECLS support)
Discharge Disposition
Time frame: through study completion (ECLS hospital discharge), an average of 2 months
Individual neurologic injury
Time frame: during the procedure (ECLS support), and up to 14 days days after ECLS stop time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No. Data received from the ELSO Registry is available to qualified researchers through an ELSO data request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph G Kohne principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic Injury (time frame: during critical illness supported by ECLS up to 14 days after ECLS stop time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.