Outcome of Patients Admitted to Pediatric Intensive Care... | NCT06470932

Studies
Outcome of Patients Admitted to Pediatric Intensive Care for Acute Respiratory Failure

NCT06470932

Sponsor

University Hospital, Grenoble

Status

Not yet recruiting

Last Update Posted

Jun 26, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Pediatric Respiratory Diseases

Interventions

Follow-up consult

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2024Estimated

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Jun 17, 2024

First Submission Date that Met QC Criteria

Jun 17, 2024

First Posted Date

Jun 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2024

Last Update Posted Date

Jun 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

EssaiClinique_SUIVIRA, Clinical professor, University Hospital, GrenoblePrincipal Investigator

Lead Sponsor

University Hospital, GrenobleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Follow up	Experimental		Diagnostic Test: Follow-up consult

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up consult	Diagnostic Test	Patients will be ask to participate to a follow-up consult	Follow up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guillaume Mortamet, MD PhD	Contact	+33681521415		gmortamet@chu-grenoble.fr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided