Clinical trial NCT00983606: An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
Official title: An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants (32 to 35 Week Gestational Age) - Outcomes and Risk Tracking Study (The Report Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2009-09-24
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature babies at birth - (32-35 WGA)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA)
* 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:

* Receipt of any RSV prophylactic agent: at any time prior to study participation
* 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

Primary outcomes:
measure: The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR
timeFrame: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011
Secondary outcomes:
measure: Rate of RSV-associated emergency department (ED) visits during the RSV season
timeFrame: 2009-2010; 2010- 2011
measure: Rate of RSV-associated hospitalization during the RSV season
timeFrame: 2009-2010; 2010-2011
measure: Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits
timeFrame: 2009-2010; 2010-2011
measure: Rate of risk factors for RSV infection
timeFrame: 2009-2010; 2010-2011
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Greenville
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Prattville
country: United States
facility: Research Site
state: Alabama
city: Scottsboro
country: United States
facility: Research Site
state: Alabama
city: Selma
country: United States
facility: Research Site
state: Alabama
city: Sylacauga
country: United States
facility: Research Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Prescott
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Bentonville
country: United States
facility: Research Site
state: Arkansas
city: Benton
country: United States
facility: Research Site
state: Arkansas
city: Fort Smith
country: United States
facility: Research Site
state: Arkansas
city: Jonesboro
country: United States
facility: Research Site
state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Chico
country: United States
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state: California
city: Fountain Valley
country: United States
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state: California
city: Fresno
country: United States
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state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Granada Hills
country: United States
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state: California
city: Hollister
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
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city: Long Beach
country: United States
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state: California
city: Los Angeles
country: United States
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city: Los Angeles
country: United States
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city: National City
country: United States
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city: San Diego
country: United States
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state: California
city: San Jose
country: United States
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city: Santa Ana
country: United States
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state: California
city: Ventura
country: United States
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state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Centennial
country: United States
facility: Research Site
state: Colorado
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Longmont
country: United States
facility: Research Site
state: Colorado
city: Louisville
country: United States
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state: Colorado
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Cantonment
country: United States
facility: Research Site
state: Florida
city: Cocoa Beach
country: United States
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state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Coral Springs
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Lake Mary
country: United States
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city: Merritt Island
country: United States
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state: Florida
city: Miami
country: United States
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city: New Port Richey
country: United States
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city: Orange Park
country: United States
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state: Florida
city: Orange Park
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Palm Beach Gardens
country: United States
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state: Florida
city: Alpharetta
country: United States
facility: Research Site
state: Georgia
city: Clarkston
country: United States
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state: Georgia
city: College Park
country: United States
facility: Research Site
state: Georgia
city: Hinesville
country: United States
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state: Georgia
city: Jesup
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Royston
country: United States
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state: Georgia
city: Snellville
country: United States
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state: Georgia
city: Stockbridge
country: United States
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state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Crystal Lake
country: United States
facility: Research Site
state: Illinois
city: Evergreen Park
country: United States
facility: Research Site
state: Illinois
city: Libertyville
country: United States
facility: Research Site
state: Illinois
city: Oak Lawn
country: United States
facility: Research Site
state: Illinois
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Jeffersonville
country: United States
facility: Research Site
state: Indiana
city: New Albany
country: United States
facility: Research Site
state: Indiana
city: Sellersburg
country: United States
facility: Research Site
state: Indiana
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Dubuque
country: United States
facility: Research Site
state: Iowa
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Bardstown
country: United States
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state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Louisville
country: United States
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state: Kentucky
city: Owensboro
country: United States
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state: Kentucky
city: Somerset
country: United States
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state: Kentucky
city: Baton Rouge
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Baltimore
country: United States
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state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Brockton
country: United States
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state: Massachusetts
city: Framingham
country: United States
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state: Massachusetts
city: Pittsfield
country: United States
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state: Massachusetts
city: Westford
country: United States
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state: Massachusetts
city: Woburn
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Bingham Farms
country: United States
facility: Research Site
state: Michigan
city: Niles
country: United States
facility: Research Site
state: Michigan
city: Stevensville
country: United States
facility: Research Site
state: Michigan
city: Duluth
country: United States
facility: Research Site
state: Minnesota
city: Brookhaven
country: United States
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state: Mississippi
city: Jackson
country: United States
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state: Mississippi
city: Newton
country: United States
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state: Mississippi
city: Bridgeton
country: United States
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state: Missouri
city: Joplin
country: United States
facility: Research Site
state: Missouri
city: North Kansas City
country: United States
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state: Missouri
city: St. Joseph
country: United States
facility: Research Site
state: Missouri
city: Lincoln
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Butler
country: United States
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state: New Jersey
city: Neptune
country: United States
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state: New Jersey
city: New Brunswick
country: United States
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state: New Jersey
city: Paterson
country: United States
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state: New Jersey
city: Princeton
country: United States
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Vineland
country: United States
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state: New Jersey
city: Woodcliff Lake
country: United States
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state: New Jersey
city: Bronx
country: United States
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state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
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state: New York
city: Brooklyn
country: United States
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state: New York
city: Brooklyn
country: United States
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state: New York
city: Buffalo
country: United States
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state: New York
city: Commack
country: United States
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state: New York
city: Jamaica
country: United States
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state: New York
city: Jericho
country: United States
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state: New York
city: Liverpool
country: United States
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state: New York
city: Mineola
country: United States
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state: New York
city: Nanuet
country: United States
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state: New York
city: New Hyde Park
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Utica
country: United States
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state: New York
city: Valley Stream
country: United States
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state: New York
city: Albemarle
country: United States
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state: North Carolina
city: Asheville
country: United States
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state: North Carolina
city: Boone
country: United States
facility: Research Site
state: North Carolina
city: Clyde
country: United States
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state: North Carolina
city: Morganton
country: United States
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state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Raliegh
country: United States
facility: Research Site
state: North Carolina
city: Trinity
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Grand Forks
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
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state: Ohio
city: Cleveland
country: United States
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state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Coal Grove
country: United States
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state: Ohio
city: Columbus
country: United States
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state: Ohio
city: Fairfield
country: United States
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state: Ohio
city: Huber Heights
country: United States
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state: Ohio
city: Kent
country: United States
facility: Research Site
state: Ohio
city: Lancaster
country: United States
facility: Research Site
state: Ohio
city: Massillon
country: United States
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state: Ohio
city: Toledo
country: United States
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state: Ohio
city: Youngstown
country: United States
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state: Ohio
city: Youngstown
country: United States
facility: Research Site
state: Ohio
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Research Site
state: Oklahoma
city: Grants Pass
country: United States
facility: Research Site
state: Oregon
city: Gresham
country: United States
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state: Oregon
city: McMinnville
country: United States
facility: Research Site
state: Oregon
city: Hanover
country: United States
facility: Research Site
state: Pennsylvania
city: Kittanning
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Research Site
state: Pennsylvania
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Providence
country: United States
facility: Research Site
state: Rhode Island
city: Barnwell
country: United States
facility: Research Site
state: South Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Cheraw
country: United States
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state: South Carolina
city: Clarksville
country: United States
facility: Research Site
state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Lebanon
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Tullahoma
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Carrollton
country: United States
facility: Research Site
state: Texas
city: Fort Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Smithville
country: United States
facility: Research Site
state: Texas
city: Sugar Land
country: United States
facility: Research Site
state: Texas
city: Tomball
country: United States
facility: Research Site
state: Texas
city: St. George
country: United States
facility: Research Site
state: Utah
city: West Jordan
country: United States
facility: Research Site
state: Utah
city: Alexandria
country: United States
facility: Research Site
state: Virginia
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Glen Allen
country: United States
facility: Research Site
state: Virginia
city: Midlothian
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Springfield
country: United States
facility: Research Site
state: Virginia
city: Vienna
country: United States
facility: Research Site
state: Virginia
city: Centralia
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Woodinville
country: United States
facility: Research Site
state: Washington
city: Charleston
country: United States
facility: Research Site
state: West Virginia
city: LaCrosse
country: United States
facility: Research Site
state: Wisconsin
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Monroe
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: MedImmune LLC
name: Jessie Groothuis, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.