En observationsundersøgelse for at vurdere respiratorisk syncytial virus (RSV) respiratoriske hændelser blandt præmature spædbørn
13. november 2012 opdateret af: MedImmune LLC
En observationel prospektiv undersøgelse til vurdering af respiratorisk syncytialvirus (RSV) respiratoriske hændelser blandt for tidligt fødte spædbørn (32 til 35 ugers svangerskabsalder) - undersøgelse af resultater og risikosporing (Rapportundersøgelsen)
Det primære formål er at vurdere byrden af luftvejssygdomme i ambulante omgivelser blandt spædbørn i 32 til 35 ugers gestationsalder (wGA) i USA, som ikke modtog RSV-profylakse i spædbørns første RSV-sæson.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Det primære mål er at bestemme byrden af RSV-sygdom i ambulante omgivelser blandt 32 til 35 wGA-spædbørn i USA, som ikke modtog RSV-profylakse, målt ved frekvensen af RSV-associeret ambulant nedre luftvejssygdom (LRI) under spædbørns første RSV sæson.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
3000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35209
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Birmingham, Alabama, Forenede Stater, 35235
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Dothan, Alabama, Forenede Stater, 36305
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Greenville, Alabama, Forenede Stater, 36037
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Mobile, Alabama, Forenede Stater, 36604
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Prattville, Alabama, Forenede Stater, 36066
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Scottsboro, Alabama, Forenede Stater, 35768
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Selma, Alabama, Forenede Stater, 36701
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Sylacauga, Alabama, Forenede Stater, 35150
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Tuscaloosa, Alabama, Forenede Stater, 35401
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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Mesa, Arizona, Forenede Stater, 85206
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Phoenix, Arizona, Forenede Stater, 85008
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Prescott, Arizona, Forenede Stater, 86301
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Scottsdale, Arizona, Forenede Stater, 85258
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Arkansas
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Benton, Arkansas, Forenede Stater, 72019
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Bentonville, Arkansas, Forenede Stater, 72712
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Fort Smith, Arkansas, Forenede Stater, 72901
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Jonesboro, Arkansas, Forenede Stater, 72401
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Little Rock, Arkansas, Forenede Stater, 72205
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California
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Anaheim, California, Forenede Stater, 92804
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Bakersfield, California, Forenede Stater, 93311
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Chico, California, Forenede Stater, 95926
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Fountain Valley, California, Forenede Stater, 92708
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Fresno, California, Forenede Stater, 93710
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Fresno, California, Forenede Stater, 93726
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Granada Hills, California, Forenede Stater, 91344
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Hollister, California, Forenede Stater, 95023
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Huntington Beach, California, Forenede Stater, 92647
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La Jolla, California, Forenede Stater, 92037
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Long Beach, California, Forenede Stater, 90806
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Los Angeles, California, Forenede Stater
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Los Angeles, California, Forenede Stater, 90033
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National City, California, Forenede Stater, 91950
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San Diego, California, Forenede Stater, 92120
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San Jose, California, Forenede Stater, 95128
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Santa Ana, California, Forenede Stater, 92705
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Ventura, California, Forenede Stater, 93003
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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Centennial, Colorado, Forenede Stater, 80015
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Lakewood, Colorado, Forenede Stater, 80214
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Longmont, Colorado, Forenede Stater, 80501
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Louisville, Colorado, Forenede Stater, 80027
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Delaware
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Newark, Delaware, Forenede Stater, 19711
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
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Florida
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Cantonment, Florida, Forenede Stater, 32533
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Cocoa Beach, Florida, Forenede Stater, 32931
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Coral Gables, Florida, Forenede Stater, 33146
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Coral Springs, Florida, Forenede Stater, 33065
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Gainesville, Florida, Forenede Stater, 32653
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Jacksonville, Florida, Forenede Stater, 32204
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Jacksonville, Florida, Forenede Stater, 32225
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Lake Mary, Florida, Forenede Stater, 32746
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Merritt Island, Florida, Forenede Stater, 32953
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Miami, Florida, Forenede Stater, 33156
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New Port Richey, Florida, Forenede Stater, 34655
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Orange Park, Florida, Forenede Stater, 32003
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Orange Park, Florida, Forenede Stater, 32073
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Orlando, Florida, Forenede Stater, 32806
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Palm Beach Gardens, Florida, Forenede Stater, 33410
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Georgia
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Alpharetta, Georgia, Forenede Stater, 30005
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Clarkston, Georgia, Forenede Stater, 30021
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College Park, Georgia, Forenede Stater, 30349
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Hinesville, Georgia, Forenede Stater, 31313
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Jesup, Georgia, Forenede Stater, 31545
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Marietta, Georgia, Forenede Stater, 30062
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Royston, Georgia, Forenede Stater, 30662
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Snellville, Georgia, Forenede Stater, 30078
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Stockbridge, Georgia, Forenede Stater, 30281
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
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Chicago, Illinois, Forenede Stater, 60614
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Crystal Lake, Illinois, Forenede Stater, 60014
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Evergreen Park, Illinois, Forenede Stater, 60805
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Libertyville, Illinois, Forenede Stater, 60048
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Oak Lawn, Illinois, Forenede Stater, 60453
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Park Ridge, Illinois, Forenede Stater, 60068
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
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Indianapolis, Indiana, Forenede Stater, 46256
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Jeffersonville, Indiana, Forenede Stater, 47130
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New Albany, Indiana, Forenede Stater, 47150
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Sellersburg, Indiana, Forenede Stater, 47172
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South Bend, Indiana, Forenede Stater, 46601
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Iowa
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Dubuque, Iowa, Forenede Stater, 52001
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Iowa City, Iowa, Forenede Stater, 52242
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Kansas
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Topeka, Kansas, Forenede Stater, 66604
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Wichita, Kansas, Forenede Stater, 67226
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
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Louisville, Kentucky, Forenede Stater, 40202
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Louisville, Kentucky, Forenede Stater, 40207
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Louisville, Kentucky, Forenede Stater, 40205
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Owensboro, Kentucky, Forenede Stater, 42303
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Somerset, Kentucky, Forenede Stater, 42503
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70806
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Shreveport, Louisiana, Forenede Stater, 71103
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Shreveport, Louisiana, Forenede Stater, 71101
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
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Brockton, Massachusetts, Forenede Stater, 02302
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Framingham, Massachusetts, Forenede Stater, 01702
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Pittsfield, Massachusetts, Forenede Stater, 01201
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Westford, Massachusetts, Forenede Stater, 01886
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Woburn, Massachusetts, Forenede Stater, 01801
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
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Bingham Farms, Michigan, Forenede Stater, 48025
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Niles, Michigan, Forenede Stater, 49120
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Stevensville, Michigan, Forenede Stater, 49127
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
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Mississippi
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Brookhaven, Mississippi, Forenede Stater, 39601
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Jackson, Mississippi, Forenede Stater, 39216
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Newton, Mississippi, Forenede Stater, 39345
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Missouri
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Bridgeton, Missouri, Forenede Stater, 63044
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Joplin, Missouri, Forenede Stater, 64804
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North Kansas City, Missouri, Forenede Stater, 64116
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St. Joseph, Missouri, Forenede Stater, 64507
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68504
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Omaha, Nebraska, Forenede Stater, 68131
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89107
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New Jersey
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Butler, New Jersey, Forenede Stater, 07405
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Neptune, New Jersey, Forenede Stater, 07753
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New Brunswick, New Jersey, Forenede Stater, 08901
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Paterson, New Jersey, Forenede Stater, 07503
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Princeton, New Jersey, Forenede Stater, 08540
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Toms River, New Jersey, Forenede Stater, 08753
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Vineland, New Jersey, Forenede Stater, 08360
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Woodcliff Lake, New Jersey, Forenede Stater, 07677
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New York
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Bronx, New York, Forenede Stater, 10467
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Brooklyn, New York, Forenede Stater, 11201
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Brooklyn, New York, Forenede Stater, 11203
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Brooklyn, New York, Forenede Stater, 11219
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Brooklyn, New York, Forenede Stater, 1285301
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Buffalo, New York, Forenede Stater, 14222
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Commack, New York, Forenede Stater, 11725
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Jamaica, New York, Forenede Stater, 11432
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Jericho, New York, Forenede Stater, 11753
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Liverpool, New York, Forenede Stater, 13088
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Mineola, New York, Forenede Stater, 11501
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Nanuet, New York, Forenede Stater, 10954
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New Hyde Park, New York, Forenede Stater, 11040
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Rochester, New York, Forenede Stater, 14618
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Syracuse, New York, Forenede Stater, 13210
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Utica, New York, Forenede Stater, 13502
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Valley Stream, New York, Forenede Stater, 11580
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North Carolina
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Albemarle, North Carolina, Forenede Stater, 28001
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Asheville, North Carolina, Forenede Stater, 28803
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Boone, North Carolina, Forenede Stater, 28607
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Clyde, North Carolina, Forenede Stater, 28721
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Morganton, North Carolina, Forenede Stater, 28655
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Raleigh, North Carolina, Forenede Stater, 27609
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Raliegh, North Carolina, Forenede Stater, 27615
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Trinity, North Carolina, Forenede Stater, 27370
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Winston-Salem, North Carolina, Forenede Stater, 27157
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North Dakota
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Grand Forks, North Dakota, Forenede Stater, 58201
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45245
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Cleveland, Ohio, Forenede Stater, 44109
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Cleveland, Ohio, Forenede Stater, 44221
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Coal Grove, Ohio, Forenede Stater, 45638
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Columbus, Ohio, Forenede Stater, 43219
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Fairfield, Ohio, Forenede Stater, 45014
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Huber Heights, Ohio, Forenede Stater, 45424
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Kent, Ohio, Forenede Stater, 44240
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Lancaster, Ohio, Forenede Stater, 43130
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Massillon, Ohio, Forenede Stater, 44646
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Toledo, Ohio, Forenede Stater, 43608
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Youngstown, Ohio, Forenede Stater, 44501
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Youngstown, Ohio, Forenede Stater, 44505
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Oklahoma
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Norman, Oklahoma, Forenede Stater, 73071
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Oklahoma City, Oklahoma, Forenede Stater, 73112
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Oklahoma City, Oklahoma, Forenede Stater, 73139
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Tulsa, Oklahoma, Forenede Stater, 74127
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Oregon
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Grants Pass, Oregon, Forenede Stater, 97527
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Gresham, Oregon, Forenede Stater, 97030
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McMinnville, Oregon, Forenede Stater, 97128
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Pennsylvania
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Hanover, Pennsylvania, Forenede Stater, 17331
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Kittanning, Pennsylvania, Forenede Stater, 16201
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Philadelphia, Pennsylvania, Forenede Stater, 19116
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Pittsburgh, Pennsylvania, Forenede Stater, 15202
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Sellersville, Pennsylvania, Forenede Stater, 18960
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
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Providence, Rhode Island, Forenede Stater, 02905
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South Carolina
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Barnwell, South Carolina, Forenede Stater, 29812
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Charleston, South Carolina, Forenede Stater, 29425
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Charleston, South Carolina, Forenede Stater, 29406
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Cheraw, South Carolina, Forenede Stater, 29520
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Tennessee
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Clarksville, Tennessee, Forenede Stater, 37043
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Kingsport, Tennessee, Forenede Stater, 37660
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Lebanon, Tennessee, Forenede Stater, 37087
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Nashville, Tennessee, Forenede Stater, 37232
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Tullahoma, Tennessee, Forenede Stater, 37388
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Texas
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Austin, Texas, Forenede Stater, 78745
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Carrollton, Texas, Forenede Stater, 75010
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Fort Worth, Texas, Forenede Stater, 76102
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Houston, Texas, Forenede Stater, 77030
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Houston, Texas, Forenede Stater, 77054
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Houston, Texas, Forenede Stater, 77087
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Lubbock, Texas, Forenede Stater, 79424
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San Antonio, Texas, Forenede Stater, 78229
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San Antonio, Texas, Forenede Stater, 78212
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San Antonio, Texas, Forenede Stater, 78217
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San Antonio, Texas, Forenede Stater, 78273
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Smithville, Texas, Forenede Stater, 78957
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Sugar Land, Texas, Forenede Stater, 77479
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Tomball, Texas, Forenede Stater, 77375
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Utah
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St. George, Utah, Forenede Stater, 84790
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West Jordan, Utah, Forenede Stater, 84084
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Virginia
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Alexandria, Virginia, Forenede Stater, 22302
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Chesapeake, Virginia, Forenede Stater, 23320
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Fairfax, Virginia, Forenede Stater, 22031
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Glen Allen, Virginia, Forenede Stater, 23060
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Midlothian, Virginia, Forenede Stater, 23113
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Norfolk, Virginia, Forenede Stater, 23507
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Richmond, Virginia, Forenede Stater, 23225
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Richmond, Virginia, Forenede Stater, 23219
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Springfield, Virginia, Forenede Stater, 22150
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Vienna, Virginia, Forenede Stater, 22180
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Washington
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Centralia, Washington, Forenede Stater, 98531
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Spokane, Washington, Forenede Stater, 99204
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Woodinville, Washington, Forenede Stater, 98072
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25304
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Wisconsin
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LaCrosse, Wisconsin, Forenede Stater, 54601
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Madison, Wisconsin, Forenede Stater, 537924108
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Milwaukee, Wisconsin, Forenede Stater, 53226
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Monroe, Wisconsin, Forenede Stater, 53566
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
For tidligt fødte børn ved fødslen - (32-35 WGA)
Beskrivelse
Inklusionskriterier:
- For tidlig ved fødslen (fra 32 uger og 0 dage til 35 uger og 6 dage GA)
- Alder 6 måneder eller derunder på screeningstidspunktet og født i maj 2009 til januar 2010 for sæson 1, eller maj 2010 til februar 2011 for sæson 2
- Skriftligt informeret samtykke og enhver lokalt påkrævet autorisation (f.eks. HIPAA), indhentet fra forsøgspersonens forælder/eller værge før udførelse af protokolrelaterede procedurer.
Ekskluderingskriterier:
- Modtagelse af ethvert RSV-profylaktisk middel: på ethvert tidspunkt før studiedeltagelse
- Deltagelse i undersøgelser af RSV-profylakse eller RSV-terapeutiske midler
- Tilstedeværelse af bronkopulmonal dysplasi, hæmodynamisk signifikant medfødt hjertesygdom, medfødt neuromuskulær eller medfødt luftvejsdefekt
- Enhver betingelse, der efter efterforskerens opfattelse ville begrænse den forventede levetid til mindre end 6 måneder
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
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1
32 til 35 WGA-spædbørn under seks måneder efter RSV-sæsonens top.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Det primære endepunkt er forekomsten af ambulant RSV LRI i løbet af RSV-sæsonen, med RSV LRI bestemt ved realtids RT-PCR
Tidsramme: Sep. 2009-feb. 2010; sep. 2010-feb. 2011
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Sep. 2009-feb. 2010; sep. 2010-feb. 2011
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antallet af RSV-associerede akutafdelingsbesøg (ED) i løbet af RSV-sæsonen
Tidsramme: 2009-2010; 2010-2011
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2009-2010; 2010-2011
|
|
Hyppigheden af RSV-associeret hospitalsindlæggelse i løbet af RSV-sæsonen
Tidsramme: 2009-2010; 2010-2011
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2009-2010; 2010-2011
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Rate af risikofaktorer for RSV-associeret ambulant LRI, hospitalsindlæggelse og ED-besøg
Tidsramme: 2009-2010; 2010-2011
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2009-2010; 2010-2011
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Rate af risikofaktorer for RSV-infektion
Tidsramme: 2009-2010; 2010-2011
|
2009-2010; 2010-2011
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Jessie Groothuis, MD, MedImmune LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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. Erratum In: PLoS One. 2016 Dec 13;11(12 ):e0168882.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2009
Primær færdiggørelse (Faktiske)
1. juni 2011
Studieafslutning (Faktiske)
1. juli 2011
Datoer for studieregistrering
Først indsendt
23. september 2009
Først indsendt, der opfyldte QC-kriterier
23. september 2009
Først opslået (Skøn)
24. september 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. november 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MI-MA213
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .