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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Dept. Subjects with LRI or Apnea | Other | No intervention; Epidemiological Study |
|
| 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 |
| 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. |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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Eligible subjects with RSV results.
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| Name | Affiliation | Role |
|---|---|---|
| Jessie R. Groothuis, M.D. | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center | Phoenix | Arizona | 85008 | United States | ||
| Olive View- UCLA Medical Center |
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Nasal wash specimen (RSV)
| 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 |
| 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 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D001988 | Bronchiolitis |
| D011014 | Pneumonia |
| D001049 | Apnea |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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