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Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at up to 12 months of age.
This surveillance study will enroll approximately 500 eligible infants from approximately 40 study sites in the US, hospitalized for laboratory-confirmed, nosocomial or community-acquired RSV disease during the study eligibility period of 1 October 2014 through 30 April 2015 (Season 1) and 1 October 2015 through 30 April 2016 (Season 2). During these eligibility periods, infants may be enrolled:
Regardless of the timing of study enrollment (i.e., in relation to the date of discharge from the index RSVH), sites will identify all infants eligible for study participation, including those treated in the inpatient ward and intensive care unit (ICU). Identification of all potentially eligible infants will be ensured through the review of the EMR, or other local healthcare database deemed appropriate for study purposes by the Study Coordinating Center (SCC).
The clinical, humanistic and health economic outcomes associated with the RSV disease will be characterized in the outpatient and inpatient settings, from the onset of symptoms of RSV disease pre index RSVH to up to 4 months post index RSVH discharge date (additionally to 12 months post index RSVH discharge date in Season 1 only), on the basis of medical records and Parent/Guardian self-report. Information regarding any sequelae associated with the index RSVH, medically-attended wheezing episodes, loss of work productivity and healthcare resource utilization (HRU) related to the management of RSV-related disease will also be collected from the medical records and Parent/Guardian by telephone interview at approximately 1 month and 4 months following discharge from the index RSVH (additionally at 12 months in Season 1 only).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm Infants 29-35 Weeks Gestation <12 months of age | Preterm Infants 29-35 Weeks Gestation <12 months of age |
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| Measure | Description | Time Frame |
|---|---|---|
| Burden of illness (BOI) associated with hospitalization for RSV | A composite outcome of burden of illness (BOI) associated with hospitalization for RSV in terms of clinical, humanistic and health economic outcomes. | 4 Months (Additionally up to 12 Months in Season 1 only) |
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Inclusion Criteria:
Exclusion Criteria:
- Receipt of RSV immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index RSVH
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Infants born at 29 to 35 wGA not receiving RSV prophylaxis hospitalized for RSV at less than 12 months of age
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Ambrose, MD | AstraZeneca | Study Director |
| Veena Kumar, MD, MPH | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
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| Label | URL |
|---|---|
| CSR synopsis | View source |
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| Loma Linda |
| California |
| United States |
| Research Site | Long Beach | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Aurora | Colorado | United States |
| Research Site | Hartford | Connecticut | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Evanston | Illinois | United States |
| Research Site | Kansas City | Kansas | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | Jackson | Mississippi | United States |
| Research Site | Reno | Nevada | United States |
| Research Site | Atlantic City | New Jersey | United States |
| Research Site | Morristown | New Jersey | United States |
| Research Site | Paterson | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Research Site | Mineola | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Syracuse | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Greenville | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Akron | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Hershey | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Sioux Falls | South Dakota | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Galveston | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Marshfield | Wisconsin | United States |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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