An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
NCT ID: NCT00369759
Last Updated: 2009-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2048 participants
OBSERVATIONAL
2006-09-30
2008-09-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
2
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
3
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
Interventions
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Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Medical diagnosis of bronchiolitis or pneumonia, or
2. 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:
1. Cessation of breathing for \>20 seconds by history or observation, or
2. Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
3. ED primary diagnosis of apnea
* Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone
Exclusion Criteria
* Participation in trials of investigational RSV prophylaxis or therapeutic agents
1 Day
12 Months
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune Inc.
Principal Investigators
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Jessie R. Groothuis, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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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
Washington D.C., District of Columbia, 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
Children's Memorial Hospital
Chicago, Illinois, United States
University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
Lexington, Kentucky, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Children's National Medical Center
Baltimore, Maryland, United States
University of Maryland
Baltimore, Maryland, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Mississippi
Jackson, Mississippi, United States
St. Louis Children's Hospital (Washington University)
St Louis, Missouri, United States
University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease
Omaha, Nebraska, United States
Children's Hospital of Buffalo
Buffalo, New York, United States
Upstate Medical University
Syracuse, New York, United States
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Columbus Children's Hospital - Nationwide Children's of Colombus
Columbus, Ohio, United States
The Children's Medical Center of Dayton
Dayton, Ohio, United States
Doernbecher Children's Hospital Oregon Health Sciences University Hospital
Portland, Oregon, United States
Temple University Children's Medical Center
Philadelphia, Pennsylvania, United States
Medical University of SC
Charleston, South Carolina, United States
University of Tennesee, LeBonheur Children's Med. Center
Memphis, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
Austin Children's Hospital
Temple, Texas, United States
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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MI-MA133
Identifier Type: -
Identifier Source: org_study_id
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