NCT00369759已完成不适用
An Epidemiological Study to Evaluate the Seasonality of Respiratory Syncytial Virus-Associated-Lower Respiratory Tract Infections (LRI) or Apnea in Infants in the Emergency Department
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,048
- 试验地点
- 36
- 主要终点
- Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
研究概览
简要总结
The primary objective of this study is to describe the incidence of RSV-associated LRI among infants <1 year of age presenting to the ED during selected shoulder months.
详细描述
- The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants <1 year of age presenting to the ED during selected shoulder months. The total number of events will also be described.
- To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea
- To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described.
- Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described.
- To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period.
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
- 1 Day 至 12 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 this study
- •Male and female infants <1 year of age (child must be entered before his/her 1st birthday)
- •Physician diagnosis of either a) acute LRI or b) apnea below:
- •A) Acute LRI, defined as:
- •Medical diagnosis of bronchiolitis or pneumonia, or
- •In the absence of either of these diagnoses, LRI will be determined by the investigator after review of the medical record and must include at least one of the following:
- •Retractions
- •Rales or crackles
- •The presence of a new infiltrate, if a chest X-ray is available, which must be diagnosed by the ED physician or radiologist
- •B) Apnea, defined as either:
- •Cessation of breathing for >20 seconds by history or observation, or
- •Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
- •ED primary diagnosis of apnea
- •Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone
排除标准
- •Use of palivizumab or RSV-IGIV at any time prior to enrollment
- •Participation in trials of investigational RSV prophylaxis or therapeutic agents
结局指标
主要结局
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
时间窗: July 2008
次要结局
- Overall rates of RSV-associated LRI or apnea based on general ED statistics collected during the entire study period, including outside recruitment periods.(July 2008)
- Clinical outcome of infants at Emergency Dept. with RSV-associated LRI or apnea.(hospital admission, 23 hr.-observations,no. of outpatient and/or urgent care visits,ICU,mechanical ventilation,supplemental oxygen use, meds,admission rate)(July 2008)
- Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge.(July 2008)
- Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.(July 2008)
研究者
研究点 (36)
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