BronchiolitisBRONCHADNCT06842238
Descriptive Study of the Initial Management of Young Children With Moderate Acute BRONCHiotitis With Home Hospitalisation
An observational study of Bronchiolitis and Bronchiolitis Acute, run by Elsan at 1 site in France.
Trial summary
The occurrence of a first episode of acute bronchiolitis in an infant or young child (3 months-2 years) always represents a medical event that generates stress for parents and in some cases for the primary care physician when it is necessary to decide on the child's orientation for treatment. Read more about this study
- Who is it for?
- Ages 2 months to 2 years
- Conditions the study is for
- Bronchiolitis, Bronchiolitis Acute
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jun 2025to 10 Jul 2025
- 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 2 months to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Babies between 2 months and 2 years old
Who may be able to join
- Any infant with moderate bronchiolitis according to the HAS definition (except for the SpO2 criterion which must be greater than or equal to 92% to avoid the patient being on oxygen therapy upon admission)
- Age > 2 months and ≤ 2 years
- Respiratory syndrome for 48 hours
- Infant with a first episode of bronchiolitis
- Referral of the general practitioner/treating pediatrician for home hospitalisation care
- Parents' agreement for the choice of home hospitalisation care
- Non-opposition or free and informed consent of both parents to the use of the child's health data
Who cannot join
- Patient not receiving health protection
- Comorbidities: congenital heart disease with shunt, chronic pulmonary pathology including bronchopulmonary dysplasia, neuromuscular pathology, immune deficiency, multiple disabilities Congenital heart disease
- Refusal of one or both parents for the proposed pathway
- Doubts about the parents' understanding of the nature of home hospitalisation care
- Severe bronchiolitis or with saturation < 92%
- Moderate bronchiolitis but evolving for less than 48 hours
- Cases of psychiatric pathologies or depressive syndrome diagnosed in the parents.
Trial locations and contacts
1 site in 1 country.
About this study
The occurrence of a first episode of acute bronchiolitis in an infant or young child (3 months-2 years) always represents a medical event that generates stress for parents and in some cases for the primary care physician when it is necessary to decide on the child's orientation for treatment. Each year, during the winter season, this pathology affects 30% of infants under two years old (480,000 annual cases in France), generates approximately 30,000 hospitalizations and exposes to an overall mortality risk of 0.08%.
According to the recommendations of the HAS (2019), moderate bronchiolitis does not require systematic hospitalization and can be managed in a Home Hospitalization (HAD) context.
Read more
When the child's examination data do not find signs of severity, the SpO2 measurement is greater than 92% and the family context allows for return home, HAD management is a reasonable option and represents an alternative to the classic scheme of assessing the level of severity by the emergency department and subsequent hospitalization if necessary. HAD management is carried out within the framework of a very structured "patient pathway", codified and supervised by the pediatric teams and doctors of this department. This patient pathway concerns children with a moderate form of bronchiolitis without oxygen requirements at the time of inclusion. This must be 48 hours from the onset of the child's respiratory clinical signs.
The main objective of this study is to describe the need for oxygen therapy for a young child with moderate acute bronchiolitis syndrome during home hospitalization (HAD) care.
- Conditions
- Bronchiolitis, Bronchiolitis Acute
- Medical subject headings
- Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenotherapy
Need for oxygen therapy during home hospitalisation care
Measured: one month
Secondary outcomes (6)
Oxygen therapy assistance
Oxygen therapy assistance during home hospitalization care
Measured: up to one month
Home hospitalization support
Duration of home hospitalization support
Measured: up to one month
Hospitalization time
hospitalization during home hospitalization care
Measured: up to one month
QUALIN questionnaire
QUALIN questionnaire is a 34-item scale to assess an infant's quality of life.
Measured: day 1, day 7 and one month
Hospital Anxiety and Depression Scale questionnaire
HADS questionnaire has 14 items between 0 and more than 11 points
Measured: day 1, day 7 and one month
Direct costs
daily cost of home hospitalization without oxygen, daily cost of home hospitalization with oxygen, GHS bronchiolitis level 2
Measured: day 1, day 7 and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start14 Jun 2025
- Primary completion24 Jun 2025
- Study completion10 Jul 2025
Why it stopped: Premature study termination due to poor feasibility: the marked decline in bronchiolitis cases following nirsevimab (Beyfortus®) implementation significantly reduced eligible patients, resulting in insufficient recruitment to meet study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- HAD privée de Poitiers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842238
- Sponsor's protocol ID
- 2024-A01404-43
- Acronym
- BRONCHAD
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study of the Initial Management of Young Children With Moderate Acute BRONCHiotitis With Home Hospitalisation
- ClinicalTrials.gov ID
- NCT06842238
- Acronym / sponsor ID
- BRONCHAD / 2024-A01404-43
- Conditions
- Bronchiolitis, Bronchiolitis Acute
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Premature study termination due to poor feasibility: the marked decline in bronchiolitis cases following nirsevimab (Beyfortus®) implementation significantly reduced eligible patients, resulting in insufficient recruitment to meet study objectives.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- HAD privée de Poitiers
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 24 Feb 2025 (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 occurrence of a first episode of acute bronchiolitis in an infant or young child (3 months-2 years) always represents a medical event that generates stress for parents and in some cases for the primary care physician when it is necessary to decide on the child's orientation for treatment. Each year, during the winter season, this pathology affects 30% of infants under two years old (480,000 annual cases in France), generates approximately 30,000 hospitalizations and exposes to an overall mortality risk of 0.08%.
According to the recommendations of the HAS (2019), moderate bronchiolitis does not require systematic hospitalization and can be managed in a Home Hospitalization (HAD) context.
When the child's examination data do not find signs of severity, the SpO2 measurement is greater than 92% and the family context allows for return home, HAD management is a reasonable option and represents an alternative to the classic scheme of assessing the level of severity by the emergency department and subsequent hospitalization if necessary. HAD management is carried out within the framework of a very structured "patient pathway", codified and supervised by the pediatric teams and doctors of this department. This patient pathway concerns children with a moderate form of bronchiolitis without oxygen requirements at the time of inclusion. This must be 48 hours from the onset of the child's respiratory clinical signs.
The main objective of this study is to describe the need for oxygen therapy for a young child with moderate acute bronchiolitis syndrome during home hospitalization (HAD) care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies between 2 months and 2 years old
Key inclusion criteria (7 listed)
- Any infant with moderate bronchiolitis according to the HAS definition (except for the SpO2 criterion which must be greater than or equal to 92% to avoid the patient being on oxygen therapy upon admission)
- Age > 2 months and ≤ 2 years
- Respiratory syndrome for 48 hours
- Infant with a first episode of bronchiolitis
- Referral of the general practitioner/treating pediatrician for home hospitalisation care
Key exclusion criteria (7 listed)
- Patient not receiving health protection
- Comorbidities: congenital heart disease with shunt, chronic pulmonary pathology including bronchopulmonary dysplasia, neuromuscular pathology, immune deficiency, multiple disabilities Congenital heart disease
- Refusal of one or both parents for the proposed pathway
- Doubts about the parents' understanding of the nature of home hospitalisation care
- Severe bronchiolitis or with saturation < 92%
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
Oxygenotherapy
Time frame: one month
Need for oxygen therapy during home hospitalisation care
6 secondary outcomes
Oxygen therapy assistance
Time frame: up to one month
Home hospitalization support
Time frame: up to one month
Hospitalization time
Time frame: up to one month
QUALIN questionnaire
Time frame: day 1, day 7 and one month
Hospital Anxiety and Depression Scale questionnaire
Time frame: day 1, day 7 and one month
Direct costs
Time frame: day 1, day 7 and one month
Results and safety
The study was stopped early (reason given: Premature study termination due to poor feasibility: the marked decline in bronchiolitis cases following nirsevimab (Beyfortus®) implementation significantly reduced eligible patients, resulting in insufficient recruitment to meet study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bronchiolitis and Bronchiolitis Acute, run by Elsan 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 Jul 2026. 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 was stopped early (reason given: Premature study termination due to poor feasibility: the marked decline in bronchiolitis cases following nirsevimab (Beyfortus®) implementation significantly reduced eligible patients, resulting in insufficient recruitment to meet study objectives.). Results are not available in the source record.
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?
Oxygenotherapy (time frame: one month). 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 16 Jul 2026.