Descriptive Study of the Initial Management of Young Children With Moderate Acute BRONCHiotitis With Home Hospitalisation (BRONCHAD)

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 Overview

• Status: Recruiting
• Conditions: Bronchiolitis; Bronchiolitis Acute

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Khaked Husseini, Dr; Phone Number: 0549422617; Email: recherche.na@elsan.care

Study Locations

• France
  • Poitiers, France, 86000
    • Recruiting
    • Polyclinique de Poitiers - HAD
    • Contact: Khaled Husseini, Dr; Phone Number: 0549422617; Email: recherche.na@elsan.care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Babies between 2 months and 2 years old

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygenotherapy	Need for oxygen therapy during home hospitalisation care	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen therapy assistance	Oxygen therapy assistance during home hospitalization care	up to one month
Home hospitalization support	Duration of home hospitalization support	up to one month
Hospitalization time	hospitalization during home hospitalization care	up to one month
QUALIN questionnaire	QUALIN questionnaire is a 34-item scale to assess an infant's quality of life.	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	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	day 1, day 7 and one month

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: HAD privée de Poitiers

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): March 14, 2027

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 21, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 2024-A01404-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No