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The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.
The primary objective is to determine the burden of RSV disease in outpatient settings among 32 to 35 wGA infants in the USA who did not receive RSV prophylaxis, as measured by rate of RSV-associated outpatient lower respiratory tract illness (LRI) during the infants' first RSV season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 32 to 35 WGA Infants less than six months of age by RSV season peak. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR | Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of RSV-associated emergency department (ED) visits during the RSV season | 2009-2010; 2010- 2011 | |
| Rate of RSV-associated hospitalization during the RSV season | 2009-2010; 2010-2011 | |
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Inclusion Criteria:
Exclusion Criteria:
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Premature babies at birth - (32-35 WGA)
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| Name | Affiliation | Role |
|---|---|---|
| Jessie Groothuis, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35209 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27898687 | Derived | Simoes EA, Anderson EJ, Wu X, Ambrose CS. Effects of Chronologic Age and Young Child Exposure on Respiratory Syncytial Virus Disease among US Preterm Infants Born at 32 to 35 Weeks Gestation. PLoS One. 2016 Nov 29;11(11):e0166226. doi: 10.1371/journal.pone.0166226. eCollection 2016. | |
| 24622396 | Derived | Ambrose CS, Anderson EJ, Simoes EA, Wu X, Elhefni H, Park CL, Sifakis F, Groothuis JR. Respiratory syncytial virus disease in preterm infants in the U.S. born at 32-35 weeks gestation not receiving immunoprophylaxis. Pediatr Infect Dis J. 2014 Jun;33(6):576-82. doi: 10.1097/INF.0000000000000219. |
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Serum (frozen)
| Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits |
| 2009-2010; 2010-2011 |
| Rate of risk factors for RSV infection | 2009-2010; 2010-2011 |
| Birmingham |
| Alabama |
| 35235 |
| United States |
| Research Site | Dothan | Alabama | 36305 | United States |
| Research Site | Greenville | Alabama | 36037 | United States |
| Research Site | Mobile | Alabama | 36604 | United States |
| Research Site | Prattville | Alabama | 36066 | United States |
| Research Site | Scottsboro | Alabama | 35768 | United States |
| Research Site | Selma | Alabama | 36701 | United States |
| Research Site | Sylacauga | Alabama | 35150 | United States |
| Research Site | Tuscaloosa | Alabama | 35401 | United States |
| Research Site | Chandler | Arizona | 85224 | United States |
| Research Site | Mesa | Arizona | 85206 | United States |
| Research Site | Phoenix | Arizona | 85008 | United States |
| Research Site | Prescott | Arizona | 86301 | United States |
| Research Site | Scottsdale | Arizona | 85258 | United States |
| Research Site | Benton | Arkansas | 72019 | United States |
| Research Site | Bentonville | Arkansas | 72712 | United States |
| Research Site | Fort Smith | Arkansas | 72901 | United States |
| Research Site | Jonesboro | Arkansas | 72401 | United States |
| Research Site | Little Rock | Arkansas | 72205 | United States |
| Research Site | Anaheim | California | 92804 | United States |
| Research Site | Bakersfield | California | 93311 | United States |
| Research Site | Chico | California | 95926 | United States |
| Research Site | Fountain Valley | California | 92708 | United States |
| Research Site | Fresno | California | 93710 | United States |
| Research Site | Fresno | California | 93726 | United States |
| Research Site | Granada Hills | California | 91344 | United States |
| Research Site | Hollister | California | 95023 | United States |
| Research Site | Huntington Beach | California | 92647 | United States |
| Research Site | La Jolla | California | 92037 | United States |
| Research Site | Long Beach | California | 90806 | United States |
| Research Site | Los Angeles | California | 90033 | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | National City | California | 91950 | United States |
| Research Site | San Diego | California | 92120 | United States |
| Research Site | San Jose | California | 95128 | United States |
| Research Site | Santa Ana | California | 92705 | United States |
| Research Site | Ventura | California | 93003 | United States |
| Research Site | Aurora | Colorado | 80045 | United States |
| Research Site | Centennial | Colorado | 80015 | United States |
| Research Site | Lakewood | Colorado | 80214 | United States |
| Research Site | Longmont | Colorado | 80501 | United States |
| Research Site | Louisville | Colorado | 80027 | United States |
| Research Site | Newark | Delaware | 19711 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Cantonment | Florida | 32533 | United States |
| Research Site | Cocoa Beach | Florida | 32931 | United States |
| Research Site | Coral Gables | Florida | 33146 | United States |
| Research Site | Coral Springs | Florida | 33065 | United States |
| Research Site | Gainesville | Florida | 32653 | United States |
| Research Site | Jacksonville | Florida | 32204 | United States |
| Research Site | Jacksonville | Florida | 32225 | United States |
| Research Site | Lake Mary | Florida | 32746 | United States |
| Research Site | Merritt Island | Florida | 32953 | United States |
| Research Site | Miami | Florida | 33156 | United States |
| Research Site | New Port Richey | Florida | 34655 | United States |
| Research Site | Orange Park | Florida | 32003 | United States |
| Research Site | Orange Park | Florida | 32073 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Palm Beach Gardens | Florida | 33410 | United States |
| Research Site | Alpharetta | Georgia | 30005 | United States |
| Research Site | Clarkston | Georgia | 30021 | United States |
| Research Site | College Park | Georgia | 30349 | United States |
| Research Site | Hinesville | Georgia | 31313 | United States |
| Research Site | Jesup | Georgia | 31545 | United States |
| Research Site | Marietta | Georgia | 30062 | United States |
| Research Site | Royston | Georgia | 30662 | United States |
| Research Site | Snellville | Georgia | 30078 | United States |
| Research Site | Stockbridge | Georgia | 30281 | United States |
| Research Site | Chicago | Illinois | 60612 | United States |
| Research Site | Chicago | Illinois | 60614 | United States |
| Research Site | Crystal Lake | Illinois | 60014 | United States |
| Research Site | Evergreen Park | Illinois | 60805 | United States |
| Research Site | Libertyville | Illinois | 60048 | United States |
| Research Site | Oak Lawn | Illinois | 60453 | United States |
| Research Site | Park Ridge | Illinois | 60068 | United States |
| Research Site | Fort Wayne | Indiana | 46804 | United States |
| Research Site | Indianapolis | Indiana | 46256 | United States |
| Research Site | Jeffersonville | Indiana | 47130 | United States |
| Research Site | New Albany | Indiana | 47150 | United States |
| Research Site | Sellersburg | Indiana | 47172 | United States |
| Research Site | South Bend | Indiana | 46601 | United States |
| Research Site | Dubuque | Iowa | 52001 | United States |
| Research Site | Iowa City | Iowa | 52242 | United States |
| Research Site | Topeka | Kansas | 66604 | United States |
| Research Site | Wichita | Kansas | 67226 | United States |
| Research Site | Bardstown | Kentucky | 40004 | United States |
| Research Site | Louisville | Kentucky | 40202 | United States |
| Research Site | Louisville | Kentucky | 40205 | United States |
| Research Site | Louisville | Kentucky | 40207 | United States |
| Research Site | Owensboro | Kentucky | 42303 | United States |
| Research Site | Somerset | Kentucky | 42503 | United States |
| Research Site | Baton Rouge | Louisiana | 70806 | United States |
| Research Site | Shreveport | Louisiana | 71101 | United States |
| Research Site | Shreveport | Louisiana | 71103 | United States |
| Research Site | Baltimore | Maryland | 21201 | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Brockton | Massachusetts | 02302 | United States |
| Research Site | Framingham | Massachusetts | 01702 | United States |
| Research Site | Pittsfield | Massachusetts | 01201 | United States |
| Research Site | Westford | Massachusetts | 01886 | United States |
| Research Site | Woburn | Massachusetts | 01801 | United States |
| Research Site | Ann Arbor | Michigan | 48106 | United States |
| Research Site | Bingham Farms | Michigan | 48025 | United States |
| Research Site | Niles | Michigan | 49120 | United States |
| Research Site | Stevensville | Michigan | 49127 | United States |
| Research Site | Duluth | Minnesota | 55805 | United States |
| Research Site | Brookhaven | Mississippi | 39601 | United States |
| Research Site | Jackson | Mississippi | 39216 | United States |
| Research Site | Newton | Mississippi | 39345 | United States |
| Research Site | Bridgeton | Missouri | 63044 | United States |
| Research Site | Joplin | Missouri | 64804 | United States |
| Research Site | North Kansas City | Missouri | 64116 | United States |
| Research Site | Saint Joseph | Missouri | 64507 | United States |
| Research Site | Lincoln | Nebraska | 68504 | United States |
| Research Site | Omaha | Nebraska | 68131 | United States |
| Research Site | Las Vegas | Nevada | 89107 | United States |
| Research Site | Butler | New Jersey | 07405 | United States |
| Research Site | Neptune City | New Jersey | 07753 | United States |
| Research Site | New Brunswick | New Jersey | 08901 | United States |
| Research Site | Paterson | New Jersey | 07503 | United States |
| Research Site | Princeton | New Jersey | 08540 | United States |
| Research Site | Toms River | New Jersey | 08753 | United States |
| Research Site | Vineland | New Jersey | 08360 | United States |
| Research Site | Woodcliff Lake | New Jersey | 07677 | United States |
| Research Site | Brooklyn | New York | 11201 | United States |
| Research Site | Brooklyn | New York | 11203 | United States |
| Research Site | Brooklyn | New York | 11219 | United States |
| Research Site | Brooklyn | New York | 1285301 | United States |
| Research Site | Buffalo | New York | 14222 | United States |
| Research Site | Commack | New York | 11725 | United States |
| Research Site | Jamaica | New York | 11432 | United States |
| Research Site | Jericho | New York | 11753 | United States |
| Research Site | Liverpool | New York | 13088 | United States |
| Research Site | Mineola | New York | 11501 | United States |
| Research Site | Nanuet | New York | 10954 | United States |
| Research Site | New Hyde Park | New York | 11040 | United States |
| Research Site | Rochester | New York | 14618 | United States |
| Research Site | Syracuse | New York | 13210 | United States |
| Research Site | The Bronx | New York | 10467 | United States |
| Research Site | Utica | New York | 13502 | United States |
| Research Site | Valley Stream | New York | 11580 | United States |
| Research Site | Albemarle | North Carolina | 28001 | United States |
| Research Site | Asheville | North Carolina | 28803 | United States |
| Research Site | Boone | North Carolina | 28607 | United States |
| Research Site | Clyde | North Carolina | 28721 | United States |
| Research Site | Morganton | North Carolina | 28655 | United States |
| Research Site | Raleigh | North Carolina | 27609 | United States |
| Research Site | Raliegh | North Carolina | 27615 | United States |
| Research Site | Trinity | North Carolina | 27370 | United States |
| Research Site | Winston-Salem | North Carolina | 27157 | United States |
| Research Site | Grand Forks | North Dakota | 58201 | United States |
| Research Site | Cincinnati | Ohio | 45245 | United States |
| Research Site | Cleveland | Ohio | 44109 | United States |
| Research Site | Cleveland | Ohio | 44221 | United States |
| Research Site | Coal Grove | Ohio | 45638 | United States |
| Research Site | Columbus | Ohio | 43219 | United States |
| Research Site | Fairfield | Ohio | 45014 | United States |
| Research Site | Huber Heights | Ohio | 45424 | United States |
| Research Site | Kent | Ohio | 44240 | United States |
| Research Site | Lancaster | Ohio | 43130 | United States |
| Research Site | Massillon | Ohio | 44646 | United States |
| Research Site | Toledo | Ohio | 43608 | United States |
| Research Site | Youngstown | Ohio | 44501 | United States |
| Research Site | Youngstown | Ohio | 44505 | United States |
| Research Site | Norman | Oklahoma | 73071 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Oklahoma City | Oklahoma | 73139 | United States |
| Research Site | Tulsa | Oklahoma | 74127 | United States |
| Research Site | Grants Pass | Oregon | 97527 | United States |
| Research Site | Gresham | Oregon | 97030 | United States |
| Research Site | McMinnville | Oregon | 97128 | United States |
| Research Site | Hanover | Pennsylvania | 17331 | United States |
| Research Site | Kittanning | Pennsylvania | 16201 | United States |
| Research Site | Philadelphia | Pennsylvania | 19116 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15202 | United States |
| Research Site | Sellersville | Pennsylvania | 18960 | United States |
| Research Site | Providence | Rhode Island | 02903 | United States |
| Research Site | Providence | Rhode Island | 02905 | United States |
| Research Site | Barnwell | South Carolina | 29812 | United States |
| Research Site | Charleston | South Carolina | 29406 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Cheraw | South Carolina | 29520 | United States |
| Research Site | Clarksville | Tennessee | 37043 | United States |
| Research Site | Kingsport | Tennessee | 37660 | United States |
| Research Site | Lebanon | Tennessee | 37087 | United States |
| Research Site | Nashville | Tennessee | 37232 | United States |
| Research Site | Tullahoma | Tennessee | 37388 | United States |
| Research Site | Austin | Texas | 78745 | United States |
| Research Site | Carrollton | Texas | 75010 | United States |
| Research Site | Fort Worth | Texas | 76102 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Houston | Texas | 77054 | United States |
| Research Site | Houston | Texas | 77087 | United States |
| Research Site | Lubbock | Texas | 79424 | United States |
| Research Site | San Antonio | Texas | 78212 | United States |
| Research Site | San Antonio | Texas | 78217 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | San Antonio | Texas | 78273 | United States |
| Research Site | Smithville | Texas | 78957 | United States |
| Research Site | Sugar Land | Texas | 77479 | United States |
| Research Site | Tomball | Texas | 77375 | United States |
| Research Site | St. George | Utah | 84790 | United States |
| Research Site | West Jordan | Utah | 84084 | United States |
| Research Site | Alexandria | Virginia | 22302 | United States |
| Research Site | Chesapeake | Virginia | 23320 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Glen Allen | Virginia | 23060 | United States |
| Research Site | Midlothian | Virginia | 23113 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Richmond | Virginia | 23219 | United States |
| Research Site | Richmond | Virginia | 23225 | United States |
| Research Site | Springfield | Virginia | 22150 | United States |
| Research Site | Vienna | Virginia | 22180 | United States |
| Research Site | Centralia | Washington | 98531 | United States |
| Research Site | Spokane | Washington | 99204 | United States |
| Research Site | Woodinville | Washington | 98072 | United States |
| Research Site | Charleston | West Virginia | 25304 | United States |
| Research Site | La Crosse | Wisconsin | 54601 | United States |
| Research Site | Madison | Wisconsin | 537924108 | United States |
| Research Site | Milwaukee | Wisconsin | 53226 | United States |
| Research Site | Monroe | Wisconsin | 53566 | United States |