Pneumonia Clinical Trial
Official title:
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
Verified date | March 2009 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2048 |
Est. completion date | September 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 12 Months |
Eligibility |
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: 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: - Use of palivizumab or RSV-IGIV at any time prior to enrollment - Participation in trials of investigational RSV prophylaxis or therapeutic agents |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | Emory University | Atlanta | Georgia |
United States | Children's National Medical Center | Baltimore | Maryland |
United States | University of Maryland | Baltimore | Maryland |
United States | Children's Hospital of Buffalo | Buffalo | New York |
United States | Medical University of SC | Charleston | South Carolina |
United States | Children's Memorial Hospital | Chicago | Illinois |
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 | 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 | The Children's Medical Center of Dayton | Dayton | Ohio |
United States | The Children's Hospital | Denver | Colorado |
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 | University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research | Lexington | Kentucky |
United States | University of Tennesee, LeBonheur Children's Med. Center | Memphis | Tennessee |
United States | Batchelor Children's Institute | Miami | Florida |
United States | Miami Children's Hospital Research Institute | Miami | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease | Omaha | Nebraska |
United States | Temple University Children's Medical Center | Philadelphia | Pennsylvania |
United States | Maricopa Medical Center | Phoenix | Arizona |
United States | Doernbecher Children's Hospital Oregon Health Sciences University Hospital | Portland | Oregon |
United States | Seattle Children's Hospital and Regional Medical Center | Seattle | Washington |
United States | Louisiana State University Health Sciences Center | Shreveport | Louisiana |
United States | St. Louis Children's Hospital (Washington University) | St. Louis | Missouri |
United States | Olive View- UCLA Medical Center | Sylmar | California |
United States | Upstate Medical University | Syracuse | New York |
United States | Austin Children's Hospital | Temple | Texas |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Alfred I. duPont Hospital for Children | Wilmington | Delaware |
United States | Alfred J. Dupont Hospital for Children | Wilmington | Delaware |
United States | Wake Forest University Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months. | July 2008 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods. | July 2008 | No | |
Secondary | 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 | No |
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