Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?

Completed

• Conditions: Brief Resolved Unexplained Events (BRUE)

• Registration Number: NCT04532320
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The malaise of the infant represents a polymorphic pathology in its clinical presentation.

Due to the young age of the patients concerned and the parental anxiety generated, hospital management is necessary, for clinical and paraclinical evaluation and monitoring.

The practice of complementary examinations is guided by personal and family history, and the precise description of the discomfort as well as clinical examination of the child and assessment of his vital parameters.

However, in view of the particular terrain represented by infants under one year of age, a number of tests are carried out systematically, and therefore empirically, because they are not guided by the clinic.

These various tests can be invasive, anxiety-provoking for parents and generate a significant additional cost during hospital management.

An evaluation of the indication and interest of these tests is necessary in order to propose a homogeneous clinical and paraclinical management of the discomfort of the infant, in particular of discomforts of type BRUE (Brief Resolved Unexplained Events), as described in the 2016 American Academy of Pediatrics (AAP) recommendations.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-08-21
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Study Completion: 2020-10-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Infant less than one year old
• Admitted to the paediatric emergencies of the CHRU of Nancy between 11/01/2019 and 04/30/2020 for discomfort

Exclusion Criteria

• Child over one year old
• Reasons for consultation in paediatric emergencies other than "malaise";

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of the proportion of BRUE-type discomfort among infants hospitalized for discomfort between 11/01/2019 and 04/30/2020	From 11/01/2019 to 04/30/2020

Secondary Outcome Measures

Name	Time	Method
- Assessment of the number of additional tests performed, their nature and the results found - Assessment of the child's orientation following consultation in paediatric emergencies (return home / hospitalization) - Epidemiological analysis	From 11/01/2019 au 04/30/2020

Trial Locations

Locations (1)

CHRU Nancy, Hôpital d'Enfants; 🇫🇷 Nancy, Lorraine, France