跳至主要内容
临床试验/NCT06842238
NCT06842238终止不适用

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

Elsan1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2025年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Oxygenotherapy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Months 至 2 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

结局指标

主要结局

Oxygenotherapy

时间窗: one month

Need for oxygen therapy during home hospitalisation care

次要结局

  • 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)
  • Direct costs(day 1, day 7 and one month)

研究者

发起方
Elsan
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验