An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
1 other identifier
observational
2,048
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2006
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2006
CompletedFirst Posted
Study publicly available on registry
August 29, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMarch 17, 2009
March 1, 2009
1.8 years
August 24, 2006
March 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
July 2008
Secondary Outcomes (4)
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
Study Arms (3)
1
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
2
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
3
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
Interventions
Eligibility Criteria
Eligible subjects with RSV results.
You may qualify if:
- 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
You may not qualify if:
- Use of palivizumab or RSV-IGIV at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (38)
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Olive View- UCLA Medical Center
Sylmar, California, 91342, United States
The Children's Hospital
Denver, Colorado, 80218, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803-3607, United States
Alfred J. Dupont Hospital for Children
Wilmington, Delaware, 19803-3607, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970, United States
Batchelor Children's Institute
Miami, Florida, 33136, United States
Miami Children's Hospital Research Institute
Miami, Florida, 33155, United States
Emory University
Atlanta, Georgia, 30329, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
Lexington, Kentucky, 40536-0298, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71130, United States
Children's National Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
St. Louis Children's Hospital (Washington University)
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease
Omaha, Nebraska, 68178, United States
Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
Upstate Medical University
Syracuse, New York, 13202, United States
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27157, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Columbus Children's Hospital - Nationwide Children's of Colombus
Columbus, Ohio, 43205, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Doernbecher Children's Hospital Oregon Health Sciences University Hospital
Portland, Oregon, 97239, United States
Temple University Children's Medical Center
Philadelphia, Pennsylvania, 19140, United States
Medical University of SC
Charleston, South Carolina, 29425, United States
University of Tennesee, LeBonheur Children's Med. Center
Memphis, Tennessee, 38103, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, 75390, United States
Austin Children's Hospital
Temple, Texas, 76502, United States
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53326, United States
Biospecimen
Nasal wash specimen (RSV)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jessie R. Groothuis, M.D.
MedImmune LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 24, 2006
First Posted
August 29, 2006
Study Start
September 1, 2006
Primary Completion
July 1, 2008
Study Completion
September 1, 2008
Last Updated
March 17, 2009
Record last verified: 2009-03