Pediatric Respiratory DiseasesNCT06470932
Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
A study testing Follow-up consult in people with Pediatric Respiratory Diseases, run by University Hospital, Grenoble.
Trial summary
This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Respiratory Diseases
- What is being tested?
- Follow-up consult
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2026
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- admitted in the PICU of Grenoble-Alps University Hospital
- for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs
Who cannot join
- already followed-up by a pediatric pulmonologist
- with congenital disease
- with long term ventilation
- still admitted at 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.
- Conditions
- Pediatric Respiratory Diseases
- Being tested
- Follow-up consult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up consultDiagnostic test
Patients will be ask to participate to a follow-up consult
| Study group | Role | What they receive |
|---|---|---|
| Follow up | Experimental | Not described Receives: Diagnostic Test: Follow-up consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life at 3 months
Quality of life at 3 months measured by PEDS QL (Pediatric Quality of Life) scale, scoring from 0 (good quality of life) to 92 (poor quality of life)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Respiratory DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EssaiClinique_SUIVIRA, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470932
- Sponsor's protocol ID
- 38RC23.0449
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 26 Jun 2024
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06470932
- Acronym / sponsor ID
- 38RC23.0449
- Conditions
- Pediatric Respiratory Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 24 Jun 2024 (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 assess the quality of life of patients six months after admission to a pediatric intensive care unit for acute respiratory failure. Children's quality of life will be assessed using the PedsQL scale at 6 months. This is a prospective cohort diagnostic and prognostic study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow up | Experimental | Diagnostic Test: Follow-up consult |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- admitted in the PICU of Grenoble-Alps University Hospital
- for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs
Key exclusion criteria (4 listed)
- already followed-up by a pediatric pulmonologist
- with congenital disease
- with long term ventilation
- still admitted at 3 months
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 |
|---|---|---|
| Follow-up consultPatients will be ask to participate to a follow-up consult | Diagnostic test | Follow up |
Primary outcome
Quality of life at 3 months
Time frame: 3 months
Quality of life at 3 months measured by PEDS QL (Pediatric Quality of Life) scale, scoring from 0 (good quality of life) to 92 (poor quality of life)
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 26 Jun 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up consult in people with Pediatric Respiratory Diseases, run by University Hospital, Grenoble.
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 4 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: opening soon, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Guillaume Mortamet, MD PhD (+33681521415, gmortamet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life at 3 months (time frame: 3 months). 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 26 Jun 2024.