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CompletedNCT04532320Updated Oct 8, 2021

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

An observational study in Brief Resolved Unexplained Events (BRUE), sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 1 Day to 365 Days. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
31
Ages
1 Day to 365 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Brief Resolved Unexplained Events (BRUE)
03

Who can participate

Ages eligible
1 Day to 365 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Child over one year old
  • Reasons for consultation in paediatric emergencies other than "malaise";
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
31 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Measurement of the proportion of BRUE-type discomfort among infants hospitalized for discomfort between 11/01/2019 and 04/30/2020

    Time frame: From 11/01/2019 to 04/30/2020

Secondary outcomes

  1. - 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

    Time frame: From 11/01/2019 au 04/30/2020

06

Study locations

1 site
  • CHRU Nancy, Hôpital d'Enfants
    Nancy, Lorraine 54000, France
07

References and documents

08

Registry details

Key details

Study ID
NCT04532320
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Noémie BERLENGI (Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Aug 31, 2020
Start date
Nov 1, 2019
Primary completion
Aug 21, 2020
Completion
Oct 8, 2020
Last update
Oct 8, 2021

Study contacts

Myriam MANGIN, Interne
study chair · CHRU Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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