Respiratory FailureNCT04798794
PCO2 ELSO (Extracorporeal Life Support Organization)
An observational study of Respiratory Failure, run by Nantes University Hospital at 1 site in France.
Trial summary
Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- ECMO for neonates
- How many people
- 4,072 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 11 Dec 2020
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates (<28 j) supported by ECMO for severe respiratory failure
Who may be able to join
- Support by ECMO for respiratory indication
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns
Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.
Read the detailed description
Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.
- Conditions
- Respiratory Failure
- Being tested
- ECMO for neonates
- Keywords
- Ecmo, Neonates
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMO for neonatesOther
Neonates (<28 j) supported by ECMO for severe respiratory failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Neurological Event
Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item:
- Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI
- Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG)
- Brain death clinically diagnosed
Measured: Up to 90 days after ECMO initiation
Secondary outcomes (1)
28-day mortality
Newborns died after 28 days despite ECMO assistance
Measured: 28 days after ECMO start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion11 Dec 2020
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.
- 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
- 4,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798794
- Sponsor's protocol ID
- JS
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns
- ClinicalTrials.gov ID
- NCT04798794
- Acronym / sponsor ID
- JS
- Conditions
- Respiratory Failure
- Keywords
- Ecmo, Neonates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,072 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 15 Mar 2021 (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.
Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.
Detailed description
Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates (<28 j) supported by ECMO for severe respiratory failure
Key inclusion criteria (1 listed)
- Support by ECMO for respiratory indication
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ECMO for neonatesNeonates (<28 j) supported by ECMO for severe respiratory failure | Other | – |
Primary outcome
Acute Neurological Event
Time frame: Up to 90 days after ECMO initiation
Onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death. The outcome (ANE) was defined by the occurrence of almost one of the following item: * Ischemic or hemmorrhagic stroke diagnosed by ultrasounds, CT or MRI * Clinical or electrical seizures : diagnosed by ElectroEncepahloGraphy (EEG) * Brain death clinically diagnosed
1 secondary outcome
28-day mortality
Time frame: 28 days after ECMO start
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 15 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nantes University Hospital at 1 site in France.
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 1 inclusion and 1 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 15 Mar 2021. 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 France. 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?
Acute Neurological Event (time frame: Up to 90 days after ECMO initiation). 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 15 Mar 2021.