An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
- Conditions
- PneumoniaRespiratory InfectionsBronchiolitisApnea
- Registration Number
- NCT00369759
- Lead Sponsor
- MedImmune LLC
- Brief Summary
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
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2048
- 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
- Use of palivizumab or RSV-IGIV at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (36)
Maricopa Medical Center
🇺🇸Phoenix, Arizona, United States
Olive View- UCLA Medical Center
🇺🇸Sylmar, California, United States
The Children's Hospital
🇺🇸Denver, Colorado, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Alfred J. Dupont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Baltimore, Maryland, United States
Batchelor Children's Institute
🇺🇸Miami, Florida, United States
Miami Children's Hospital Research Institute
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Scroll for more (26 remaining)Maricopa Medical Center🇺🇸Phoenix, Arizona, United States