Patient's Quality of Life Assessment 5 to 10 Years After Hospitalization in Intensive Care Unit for a Severe Bacterial Infection

NCT04005560 | Completed

• 1 other identifier: RC19_0128
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess patient's quality of life 5 to 10 years after a severe bacterial infection with hospitalization in a intensive unit care. The population is derived from the DIABACT III study. The investigators will include every patient still alive. To evaluate our question, patients and their parents will answer quality of life questionnaires. The investigators will also have telephone interviews with the parents to know somatic and psychological effects on their child. The investigators will see if quality of life and sequelae differ depending on various studied factors.

Conditions

Quality of Life; Sequela

Keywords

severe bacterial infection; quality of life; long term sequela; pediatric intensive care unit; children

Outcome Measures

Primary Outcomes (1)

• This quality of life will be evaluated by a questionnaire, the Pediatric Quality of Life inventory.

  The Pediatric Quality of Life inventory questionnaire has various versions depending on the patient age, from 5 years old to adult age. Patients will answers many questions in the academic, emotional, physical and social fields. It exists the same questionnaire adapted for parents. At the end, there is a score for each field and a total score.

  6 months

Secondary Outcomes (2)

• Identify quality of life determinants.

  6 months

• Assess long-term sequelae: evaluate somatic and psychological effects. We will have telephone interviews with the parents.

  6 months

Study Arms (1)

patient

OTHER

Score of PedSQL who is the Pediatric Quality of Life Questionnaire

Other: no interventional study

Interventions

no interventional study OTHER

no interventional study

patient

Eligibility Criteria

• Age: 6 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Every patients from DIABACT III study still alive at the beginning of this study

You may not qualify if:

• Patients who did not respond to the questionnaire
• Inability to contact the patient and family
• No fixed postal address

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 2, 2019
• Study Start: December 26, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

FR (1)