Critical IllnessNCT06899009
Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure
An observational study of Critical Illness and Respiratory Failure (Pediatric Patients), run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
This study aims to describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation and to explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure, using the… Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Critical Illness, Respiratory Failure (Pediatric Patients)
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Critically ill pediatric patients receiving ECMO for pulmonary indications
Who may be able to join
- Patients (aged ≥29 days to ≤18 years) receiving ECMO between January 1, 2012, and December 31, 2022, in an ELSO affiliated center; and
- Requiring ECMO for a pulmonary indication.
Who cannot join
- Patients with missing ventilatory variables required to assess ventilation intensity;
- patients who were lost to follow up with respect to hospital mortality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure - a Posthoc Analysis of the ELSO Registry
This study aims to describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation and to explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure, using the 'Extracorporeal Life Support Organization' (ELSO) registry.
Read the detailed description
Rationale:
Despite the growing use of ECMO in critically ill pediatric patients, uncertainties remain to what extent adjustments of ventilator settings after ECMO initiation are associated with mortality.
Objectives:
- To describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation; and
- To explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure
Hypothesis:
- Ventilation intensity decreases following initiation of ECMO; and
- A decrease in ventilation intensity is associated with lower hospital mortality in critically ill pediatric patients.
Study design:
This is a posthoc analysis of the ELSO registry.
Study population:
For this analysis, data will be obtained from the ELSO registry. All pediatric patients (aged ≥29 days to ≤18 years) receiving ECMO for a pulmonary indication between January 1, 2012, and December 31, 2022 will be included. Patients with missing ventilatory variables required to assess ventilation intensity and patients lost to follow up with respect to hospital mortality will be excluded.
- Keywords
- Ventilation practice, Critically ill children, Mechanical ventilation, Extracorporeal membrane oxygenation, Extracorporeal lief support
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with respiratory failure on ECMO | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: Up to 90 days of study or whatever comes first
Secondary outcomes (3)
Hospital length of stay
Measured: Up to 90 days of study or whatever comes first
Duration of ECMO run
Measured: Up to 90 days of study or whatever comes first
Duration of invasive ventilation
Measured: Up to 90 days of study or whatever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin CJ Kneyber, MD PhD FCCM, Principal investigator, University Medical Center GroningenMarcus J Schultz, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Frederique Paulus, RN PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899009
- Sponsor's protocol ID
- Ped.ECMO.1
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Mar 2025
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Settings and Outcomes in Pediatric Patients on ECMO for Severe Respiratory Failure - a Posthoc Analysis of the ELSO Registry
- ClinicalTrials.gov ID
- NCT06899009
- Acronym / sponsor ID
- Ped.ECMO.1
- Keywords
- Ventilation practice, Critically ill children, Mechanical ventilation, Extracorporeal membrane oxygenation, Extracorporeal lief support
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2025 (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.
This study aims to describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation and to explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure, using the 'Extracorporeal Life Support Organization' (ELSO) registry.
Detailed description
Rationale:
Despite the growing use of ECMO in critically ill pediatric patients, uncertainties remain to what extent adjustments of ventilator settings after ECMO initiation are associated with mortality.
Objectives:
- To describe the effects of ECMO initiation on the intensity of ventilation in the first 24 hours after ECMO initiation; and
- To explore associations between changes in ventilation intensity and hospital mortality in critically ill pediatric patients requiring ECMO for respiratory failure
Hypothesis:
- Ventilation intensity decreases following initiation of ECMO; and
- A decrease in ventilation intensity is associated with lower hospital mortality in critically ill pediatric patients.
Study design:
This is a posthoc analysis of the ELSO registry.
Study population:
For this analysis, data will be obtained from the ELSO registry. All pediatric patients (aged ≥29 days to ≤18 years) receiving ECMO for a pulmonary indication between January 1, 2012, and December 31, 2022 will be included. Patients with missing ventilatory variables required to assess ventilation intensity and patients lost to follow up with respect to hospital mortality will be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with respiratory failure on ECMO | – | – |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Critically ill pediatric patients receiving ECMO for pulmonary indications
Key inclusion criteria (2 listed)
- Patients (aged ≥29 days to ≤18 years) receiving ECMO between January 1, 2012, and December 31, 2022, in an ELSO affiliated center; and
- Requiring ECMO for a pulmonary indication.
Key exclusion criteria (2 listed)
- Patients with missing ventilatory variables required to assess ventilation intensity;
- patients who were lost to follow up with respect to hospital mortality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital mortality
Time frame: Up to 90 days of study or whatever comes first
3 secondary outcomes
Hospital length of stay
Time frame: Up to 90 days of study or whatever comes first
Duration of ECMO run
Time frame: Up to 90 days of study or whatever comes first
Duration of invasive ventilation
Time frame: Up to 90 days of study or whatever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- 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.
Martin CJ Kneyber, MD PhD FCCM principal investigator
University Medical Center Groningen
Marcus J Schultz, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Frederique Paulus, RN PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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 Critical Illness and Respiratory Failure (Pediatric Patients), run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hospital mortality (time frame: Up to 90 days of study or whatever comes first). 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 27 Mar 2025.