- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06470932
Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure
June 24, 2024 updated by: EssaiClinique_SUIVIRA, University Hospital, Grenoble
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guillaume Mortamet, MD PhD
- Phone Number: +33681521415
- Email: gmortamet@chu-grenoble.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- admitted in the PICU of Grenoble-Alps University Hospital
- for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs
Exclusion Criteria:
- already followed-up by a pediatric pulmonologist
- with congenital disease
- with long term ventilation
- still admitted at 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Follow up
|
Patients will be ask to participate to a follow-up consult
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
June 17, 2024
First Submitted That Met QC Criteria
June 17, 2024
First Posted (Actual)
June 24, 2024
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 24, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC23.0449
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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