An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
NCT ID: NCT00983606
Last Updated: 2012-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3000 participants
OBSERVATIONAL
2009-09-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
32 to 35 WGA Infants less than six months of age by RSV season peak.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2
* Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures.
Exclusion Criteria
* Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents
* Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects
* Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months
ALL
Yes
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Jessie Groothuis, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Greenville, Alabama, United States
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Mobile, Alabama, United States
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Prattville, Alabama, United States
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Scottsboro, Alabama, United States
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Selma, Alabama, United States
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Sylacauga, Alabama, United States
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Tuscaloosa, Alabama, United States
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Prescott, Arizona, United States
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Scottsdale, Arizona, United States
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Benton, Arkansas, United States
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Bentonville, Arkansas, United States
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Fort Smith, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Chico, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Fresno, California, United States
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Granada Hills, California, United States
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Hollister, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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National City, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Ana, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Centennial, Colorado, United States
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Lakewood, Colorado, United States
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Longmont, Colorado, United States
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Louisville, Colorado, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Cantonment, Florida, United States
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Cocoa Beach, Florida, United States
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Coral Gables, Florida, United States
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Coral Springs, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lake Mary, Florida, United States
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Merritt Island, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Orange Park, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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Alpharetta, Georgia, United States
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Clarkston, Georgia, United States
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College Park, Georgia, United States
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Hinesville, Georgia, United States
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Jesup, Georgia, United States
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Marietta, Georgia, United States
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Royston, Georgia, United States
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Snellville, Georgia, United States
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Stockbridge, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Crystal Lake, Illinois, United States
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Evergreen Park, Illinois, United States
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Libertyville, Illinois, United States
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Oak Lawn, Illinois, United States
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Park Ridge, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Jeffersonville, Indiana, United States
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New Albany, Indiana, United States
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Sellersburg, Indiana, United States
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South Bend, Indiana, United States
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Dubuque, Iowa, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Bardstown, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Somerset, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Framingham, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Westford, Massachusetts, United States
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Woburn, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Bingham Farms, Michigan, United States
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Niles, Michigan, United States
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Stevensville, Michigan, United States
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Duluth, Minnesota, United States
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Brookhaven, Mississippi, United States
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Jackson, Mississippi, United States
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Newton, Mississippi, United States
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Bridgeton, Missouri, United States
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Joplin, Missouri, United States
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North Kansas City, Missouri, United States
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Saint Joseph, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Butler, New Jersey, United States
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Neptune City, New Jersey, United States
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New Brunswick, New Jersey, United States
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Paterson, New Jersey, United States
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Princeton, New Jersey, United States
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Toms River, New Jersey, United States
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Vineland, New Jersey, United States
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Woodcliff Lake, New Jersey, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Commack, New York, United States
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Jamaica, New York, United States
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Jericho, New York, United States
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Liverpool, New York, United States
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Mineola, New York, United States
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Nanuet, New York, United States
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New Hyde Park, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Utica, New York, United States
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Valley Stream, New York, United States
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Albemarle, North Carolina, United States
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Asheville, North Carolina, United States
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Boone, North Carolina, United States
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Clyde, North Carolina, United States
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Morganton, North Carolina, United States
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Raleigh, North Carolina, United States
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Raliegh, North Carolina, United States
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Trinity, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Grand Forks, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Coal Grove, Ohio, United States
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Columbus, Ohio, United States
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Fairfield, Ohio, United States
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Huber Heights, Ohio, United States
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Kent, Ohio, United States
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Lancaster, Ohio, United States
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Massillon, Ohio, United States
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Toledo, Ohio, United States
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Youngstown, Ohio, United States
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Youngstown, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Grants Pass, Oregon, United States
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Gresham, Oregon, United States
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McMinnville, Oregon, United States
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Hanover, Pennsylvania, United States
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Kittanning, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Barnwell, South Carolina, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Cheraw, South Carolina, United States
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Clarksville, Tennessee, United States
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Kingsport, Tennessee, United States
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Lebanon, Tennessee, United States
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Nashville, Tennessee, United States
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Tullahoma, Tennessee, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Smithville, Texas, United States
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Sugar Land, Texas, United States
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Tomball, Texas, United States
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St. George, Utah, United States
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West Jordan, Utah, United States
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Alexandria, Virginia, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Glen Allen, Virginia, United States
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Midlothian, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Springfield, Virginia, United States
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Vienna, Virginia, United States
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Centralia, Washington, United States
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Spokane, Washington, United States
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Woodinville, Washington, United States
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Charleston, West Virginia, United States
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La Crosse, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Monroe, Wisconsin, United States
Countries
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References
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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.
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.
Other Identifiers
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MI-MA213
Identifier Type: -
Identifier Source: org_study_id