NCT06470932

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

June 17, 2024

Last Update Submit

June 24, 2024

Conditions

Pediatric Respiratory Diseases

Outcome Measures

Primary Outcomes (1)

  • 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)

    3 months

Study Arms (1)

Follow up

EXPERIMENTAL
Diagnostic Test: Follow-up consult

Interventions

Follow-up consultDIAGNOSTIC_TEST

Patients will be ask to participate to a follow-up consult

Follow up

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • admitted in the PICU of Grenoble-Alps University Hospital
  • for acute respiratory failure (code J960) requiring mechanical ventilation for at least 48hrs

You may not qualify if:

  • already followed-up by a pediatric pulmonologist
  • with congenital disease
  • with long term ventilation
  • still admitted at 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Guillaume Mortamet, MD PhD

CONTACT

+33681521415gmortamet@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

June 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share