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

NCT06842238 | Recruiting

• 1 other identifier: 2024-A01404-43
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bronchiolitis; Bronchiolitis Acute

Outcome Measures

Primary Outcomes (1)

• Oxygenotherapy

  Need for oxygen therapy during home hospitalisation care

  one month

Secondary Outcomes (6)

• Oxygen therapy assistance

  up to one month

• Home hospitalization support

  up to one month

• Hospitalization time

  up to one month

• QUALIN questionnaire

  day 1, day 7 and one month

• Hospital Anxiety and Depression Scale questionnaire

  day 1, day 7 and one month

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Babies between 2 months and 2 years old

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elsan: lead
• HAD privée de Poitiers: collaborator

Study Sites (1)

Polyclinique de Poitiers - HAD

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

Khaked Husseini, Dr

CONTACT

0549422617; recherche.na@elsan.care

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 24, 2025
• Study Start: June 14, 2025
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): March 14, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

FR (1)