Brief Resolved Unexplained Events (BRUE)NCT04532320
Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?
An observational study of Brief Resolved Unexplained Events (BRUE), run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 365 days
- Conditions the study is for
- Brief Resolved Unexplained Events (BRUE)
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to 8 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 365 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Child over one year old
- Reasons for consultation in paediatric emergencies other than "malaise";
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Brief Resolved Unexplained Events (BRUE)
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the proportion of BRUE-type discomfort among infants hospitalized for discomfort between 11/01/2019 and 04/30/2020
Measured: 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
Measured: From 11/01/2019 au 04/30/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Nov 2019
- Primary completion21 Aug 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brief Resolved Unexplained Events (BRUE)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noémie BERLENGI, Central Hospital, Nancy, France
- Investigators
- Myriam MANGIN, Interne, Study chair, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532320
- Sponsor's protocol ID
- 2020PI133
- Status last verified
- Oct 2021
- First submitted
- 26 Aug 2020
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?
- ClinicalTrials.gov ID
- NCT04532320
- Acronym / sponsor ID
- 2020PI133
- Conditions
- Brief Resolved Unexplained Events (BRUE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Child over one year old
- Reasons for consultation in paediatric emergencies other than "malaise";
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Brief Resolved Unexplained Events (Formerly Apparent Life-Threatening Events) and Evaluation of Lower-Risk InfantsLink provided by the sponsor.
Related trials for Brief Resolved Unexplained Events (BRUE)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myriam MANGIN, Interne study chair
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brief Resolved Unexplained Events (BRUE), run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.