Extracorporeal Membrane Oxygenation ComplicationECMOQoLNCT05721105
Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO)
An observational study of Extracorporeal Membrane Oxygenation Complication and Critical Care, run by Nantes University Hospital at 1 site in France.
Trial summary
The main objective of this prospective transversal comparative study is to describe the quality of life of children supported by ECMO. These patients are described in detail at the Nantes University Hospital, in particular the elements of neurological monitoring. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Critical Care
- What is being tested?
- Quality of life assessment using questionnaires
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2023to 15 Oct 2024
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: The patients included (ECMO group) will be patients under 10 years of age treated by ECMO at the University Hospital of Nantes from January 2014 to December 2022 and who have reached the age of 2 years during the study (the hetero-evaluation questionnaires for the primary endpoint being validated from this age). The controls will be patients hospitalized at the same age in pediatric intensive care and at the same periods, who have been intubated and ventilated for at least 48 hours, and/or who have received amines and/or who have benefited from organ support other than ECMO (CONTROL group).
Who may be able to join
- Patients accepted in pediatric intensive care at the Nantes University Hospital between January 2014 and December 2022
- Patients less than 10 years old at admission to the intensive care unit,
- Patients older than 2 years at the time of the cross-sectional evaluation
- For the ECMO group: Patients supported by ECMO
- For the control group: Patient intubated-ventilated for more than 48 hours and/or having received amines and/or having received organ support other than ECMO.
- Patient affiliated to the Social Security.
- Patient with parents who do not object to the study
Who cannot join
- Known genetic pathology or malformative association at the time of admission to the intensive care unit that could lead to severe neurodevelopmental deficits, independently of the medical events that resulted in the admission to the intensive care unit
- Language difficulty that does not allow for complete information and questionnaire collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study
The main objective of this prospective transversal comparative study is to describe the quality of life of children supported by ECMO. These patients are described in detail at the Nantes University Hospital, in particular the elements of neurological monitoring. These results will be analyzed in reference to a population hospitalized at the same age, in the same period, and sharing the same diagnostic categories.
- Being tested
- Quality of life assessment using questionnaires
- Keywords
- Pediatric Intensive Care, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessment using questionnairesOther
Several quality of life questionnaires will be submitted to the patients and their parents. The questionnaires will be adapted to the age of the patients.
| Study group | Role | What they receive |
|---|---|---|
| ECMO | 50 Patients admitted to pediatric intensive care at the University Hospital of Nantes between January 2014 and December 2022 and supported by ECMO during their hospitalization. Receives: Other: Quality of life assessment using questionnaires | |
| Control | 50 patients hospitalized at the same age, during the same time period, and sharing the same diagnostic categories as the ECMO group, but the control group never had ECMO. Receives: Other: Quality of life assessment using questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the overall quality of life of children aged 0-10 years supported by ECMO during their intensive care period with a population of children of the same age hospitalized in pediatric intensive care in the same period.
Quality of life evaluated by the total score of the PedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome.
Measured: 15 days
Secondary outcomes (3)
To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care with reference to a population of children of the same age hospitalized in pediatric intensive care during the same period
PedsQL (Pediatric Quality of Life Questionnaire) : Physical functioning, emotional functioning, social functioning, academic functioning.
PedsQL (Pediatric Quality of Life Questionnaire), scale from 0 to 4; 4 being the worst outcome.
Measured: up to 15 days
To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care stay to a reference consisting of healthy children, not hospitalized, studied over the same period and in the same country
PedsQL Questionnaire scores of a cohort of healthy children of the same age from the literature.
PedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome.
Measured: up to 15 days
Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start29 Nov 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 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
- NCT05721105
- Sponsor's protocol ID
- RC23_0013
- Acronym
- ECMOQoL
- Status last verified
- Nov 2024
- First submitted
- 31 Jan 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Quality of Life in Children Supported with ExtraCorporeal Membrane Oxygenation (ECMO): a Prospective Transversal Study
- ClinicalTrials.gov ID
- NCT05721105
- Acronym / sponsor ID
- ECMOQoL / RC23_0013
- Keywords
- Pediatric Intensive Care, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 9 Feb 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.
The main objective of this prospective transversal comparative study is to describe the quality of life of children supported by ECMO. These patients are described in detail at the Nantes University Hospital, in particular the elements of neurological monitoring. These results will be analyzed in reference to a population hospitalized at the same age, in the same period, and sharing the same diagnostic categories.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO | – | Other: Quality of life assessment using questionnaires50 Patients admitted to pediatric intensive care at the University Hospital of Nantes between January 2014 and December 2022 and supported by ECMO during their hospitalization. |
| Control | – | Other: Quality of life assessment using questionnaires50 patients hospitalized at the same age, during the same time period, and sharing the same diagnostic categories as the ECMO group, but the control group never had ECMO. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The patients included (ECMO group) will be patients under 10 years of age treated by ECMO at the University Hospital of Nantes from January 2014 to December 2022 and who have reached the age of 2 years during the study (the hetero-evaluation questionnaires for the primary endpoint being validated from this age). The controls will be patients hospitalized at the same age in pediatric intensive care and at the same periods, who have been intubated and ventilated for at least 48 hours, and/or who have received amines and/or who have benefited from organ support other than ECMO (CONTROL group).
Key inclusion criteria (7 listed)
- Patients accepted in pediatric intensive care at the Nantes University Hospital between January 2014 and December 2022
- Patients less than 10 years old at admission to the intensive care unit,
- Patients older than 2 years at the time of the cross-sectional evaluation
- For the ECMO group: Patients supported by ECMO
- For the control group: Patient intubated-ventilated for more than 48 hours and/or having received amines and/or having received organ support other than ECMO.
Key exclusion criteria (2 listed)
- Known genetic pathology or malformative association at the time of admission to the intensive care unit that could lead to severe neurodevelopmental deficits, independently of the medical events that resulted in the admission to the intensive care unit
- Language difficulty that does not allow for complete information and questionnaire collection
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 |
|---|---|---|
| Quality of life assessment using questionnairesSeveral quality of life questionnaires will be submitted to the patients and their parents. The questionnaires will be adapted to the age of the patients. | Other | Control, ECMO |
Primary outcome
Compare the overall quality of life of children aged 0-10 years supported by ECMO during their intensive care period with a population of children of the same age hospitalized in pediatric intensive care in the same period.
Time frame: 15 days
Quality of life evaluated by the total score of the PedsQL (Pediatric Quality of Life InventoryTM), scale from 0 to 4; 4 being the worst outcome.
3 secondary outcomes
To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care with reference to a population of children of the same age hospitalized in pediatric intensive care during the same period
Time frame: up to 15 days
To compare the different QoL dimensions of children supported by ECMO between 0 and 10 years of age during their intensive care stay to a reference consisting of healthy children, not hospitalized, studied over the same period and in the same country
Time frame: up to 15 days
Describe the association between neurological complications and their severity (seizures, clinical deficits, imaging lesions) and QoL in patients supported by ECMO.
Time frame: up to 15 days
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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 Extracorporeal Membrane Oxygenation Complication and Critical Care, 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 7 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: finished, as of the sponsor's last update on 20 Nov 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 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?
Compare the overall quality of life of children aged 0-10 years supported by ECMO during their intensive care period with a population of children of the same age hospitalized in pediatric intensive care in the same period. (time frame: 15 days). 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 20 Nov 2024.