Retrospective Examination of Initial Care of Severe Bacterial Infections of the Child

Not Applicable

Completed

• Conditions: Bacterial Infection

• Registration Number: NCT01485705
• Lead Sponsor: Nantes University Hospital

Brief Summary

The aim of the study is to determine the frequency of sub-optimal care in the initial care (before arrival at the intensive care unit) of children from "West France regions" suffering of severe bacterial infections.The characteristic "optimal or not" of the initial medical care will be determined by 2 independent experts, blinded from each other and blinded from the issue of the care. In case of a discordance between the two experts, a third expert will be demanded. Three possibilities of conclusion will be proposed to the experts: "sure sub-optimal medical care", "possible suboptimal care" and "optimal care".

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-13
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 371

Inclusion Criteria

• Child from West France regions
• Aged between 1 month and 16 years old,
• Admitted at the intensive care unit for a severe bacterial infection and with the first symptoms appeared when child was at home or hospitalized since less than 48h
• Children dead at home will also be included in this study via the mobil medical urgency help unit (french term : "SAMU")

Exclusion Criteria

• Patient not fulfilling inclusion criteria
• Child with a nosocomial infection
• Child dead or admitted at the intensive care unit following a pertussis- Child not admitted at the intensive care or not dead at home in a context of infection.
• Child with viral or fungic infection admitted at the intensive care unit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of optimal care and of non optimal care in the initial care (before arrival at the intensive care unit) of children (from West France regions) suffering of severe bacterial infections.	1day	For each child medical file, the verdict "optimal care" or the verdict " non optimal care" will be determined by two independent experts, blinded from each other. If verdict base their judgement through recommendations listed in the literature.

Secondary Outcome Measures

Name	Time	Method
determinants of sub-optimal cares	1 day	To identify determinants of sub-optimal cares (examples : place of medical care, qualification and experience of the Medical Doctor, moment of medical care.
consequences of initial sub-optimal cares	1 day	To identify consequences of initial sub-optimal cares on the outcome of children with severe bacterial infections (child death, etc).
characteristics of sub-optimal cares	1 day	Experts will explain their verdict by answering to a list of questions. These questions will allow to identify and classify characteristics of defaults of cares .

Trial Locations

Locations (1)

CHU of Nantes; 🇫🇷 Nantes, France