Brief Resolved Unexplained Events (BRUE) Clinical Trial
Official title:
Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?
| NCT number | NCT04532320 |
| Other study ID # | 2020PI133 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 1, 2019 |
| Est. completion date | October 8, 2020 |
| Verified date | October 2021 |
| Source | Central Hospital, Nancy, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | October 8, 2020 |
| Est. primary completion date | August 21, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 365 Days |
| Eligibility | 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"; |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Nancy, Hôpital d'Enfants | Nancy | Lorraine |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | - 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 |