An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Respiratory Infections, Bronchiolitis, Pneumonia, Apnea

Intervention / Treatment
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* Other: Emergency Dept. Subjects with LRI or Apnea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Wheezing 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 Exclusion Criteria: Use of palivizumab or RSV-IGIV at any time prior to enrollment Participation in trials of investigational RSV prophylaxis or therapeutic agents

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) | Other: Emergency Dept. Subjects with LRI or Apnea<br>* No intervention; Epidemiological Study<br>|
| 2<br>Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) | Other: Emergency Dept. Subjects with LRI or Apnea<br>* No intervention; Epidemiological Study<br>|
| 3<br>Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08) | Other: Emergency Dept. Subjects with LRI or Apnea<br>* No intervention; Epidemiological Study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months. |  | July 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rales, Acute Lower Respiratory Infection, Retractions, Bronchiolitis or pneumonia, Wheezing, Crackles