National Observatory of Children Hospitalized With Bronchiolitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026.
研究概览
简要总结
OVNI3 is multicenter, non-interventional study based on the analysis of retrospective patient data extracted from medical records and collected as part of routine clinical care following hospitalization for bronchiolitis
详细描述
Patients will be identified at each participating center if a diagnosis of bronchiolitis meeting the study inclusion criteria is documented in the medical record.
As this is a retrospective study based exclusively on previously collected health data (for hospitalization occurring between October 15, 2025, and February 15, 2026), and involving no additional procedures or modification of patient management, inclusion will be performed by the attending clinicians after hospitalization.
Following identification of the medical record, the clinician will send an individual information notice and a non-opposition form to the legal representatives.
Patient data will be collected in the absence of any expressed objection from one of the legal representatives.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children under 12 months
- •Treated at one of the 12 study sites
- •From October 15, 2025 to February 15, 2026
- •For acute bronchiolitis defined according to current national and international recommendations
- •Hospitalized
- •RSV testing
- •Known nirsevimab immunization status for the ongoing 2025/2026 season
排除标准
- •Refusal to participate by the legal representative
- •Maternal immunization with abrysvo after September 1st 2025
结局指标
主要结局
Evaluate the nirsevimab effectiveness for RSV Bronchiolitis hospitalized vs Non-RSV Bronchiolitis in 2025/2026.
时间窗: 6 months
This outcome evaluates the effectiveness of nirsevimab in preventing hospitalizations for RSV bronchiolitis among infants under 12 months of age during the 2025/2026 season. Effectiveness is assessed by comparing the number of hospitalizations for RSV bronchiolitis in infants who received nirsevimab versus those who did not.
次要结局
- Difference of effectiveness during the 2 seasons (2024/2025 vs 2025/2026)(2 years)
- Hospitalization Proportions according to Nirsevimab and RSV Status, based on different age Groups(6 months)
- Proportion of hospitalizations for bronchiolitis associated with other viruses (isolated or associated with RSV)(6 months)