NCT00889070已完成不适用
Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events.
研究概览
简要总结
Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.
详细描述
The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.
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
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from parent/guardian to participate in study
- •Male or female preterm infants 32-≤36 wGA
- •Infant is ≤ 6month old at the time of enrollment
- •Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol
排除标准
- •Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment
- •Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents
- •Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD)
- •Condition that limits life span to 6 months or less from the date of enrollment
结局指标
主要结局
The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events.
时间窗: Seasonal: 2008-09
次要结局
- Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.(Seasonal: 2008-09)
研究者
研究点 (5)
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