An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants

November 13, 2012 updated by: MedImmune LLC

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)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Birmingham, Alabama, United States, 35235
        • Research Site
      • Dothan, Alabama, United States, 36305
        • Research Site
      • Greenville, Alabama, United States, 36037
        • Research Site
      • Mobile, Alabama, United States, 36604
        • Research Site
      • Prattville, Alabama, United States, 36066
        • Research Site
      • Scottsboro, Alabama, United States, 35768
        • Research Site
      • Selma, Alabama, United States, 36701
        • Research Site
      • Sylacauga, Alabama, United States, 35150
        • Research Site
      • Tuscaloosa, Alabama, United States, 35401
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Research Site
      • Mesa, Arizona, United States, 85206
        • Research Site
      • Phoenix, Arizona, United States, 85008
        • Research Site
      • Prescott, Arizona, United States, 86301
        • Research Site
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • Arkansas
      • Benton, Arkansas, United States, 72019
        • Research Site
      • Bentonville, Arkansas, United States, 72712
        • Research Site
      • Fort Smith, Arkansas, United States, 72901
        • Research Site
      • Jonesboro, Arkansas, United States, 72401
        • Research Site
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Anaheim, California, United States, 92804
        • Research Site
      • Bakersfield, California, United States, 93311
        • Research Site
      • Chico, California, United States, 95926
        • Research Site
      • Fountain Valley, California, United States, 92708
        • Research Site
      • Fresno, California, United States, 93710
        • Research Site
      • Fresno, California, United States, 93726
        • Research Site
      • Granada Hills, California, United States, 91344
        • Research Site
      • Hollister, California, United States, 95023
        • Research Site
      • Huntington Beach, California, United States, 92647
        • Research Site
      • La Jolla, California, United States, 92037
        • Research Site
      • Long Beach, California, United States, 90806
        • Research Site
      • Los Angeles, California, United States
        • Research Site
      • Los Angeles, California, United States, 90033
        • Research Site
      • National City, California, United States, 91950
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • San Jose, California, United States, 95128
        • Research Site
      • Santa Ana, California, United States, 92705
        • Research Site
      • Ventura, California, United States, 93003
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
      • Centennial, Colorado, United States, 80015
        • Research Site
      • Lakewood, Colorado, United States, 80214
        • Research Site
      • Longmont, Colorado, United States, 80501
        • Research Site
      • Louisville, Colorado, United States, 80027
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19711
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Research Site
    • Florida
      • Cantonment, Florida, United States, 32533
        • Research Site
      • Cocoa Beach, Florida, United States, 32931
        • Research Site
      • Coral Gables, Florida, United States, 33146
        • Research Site
      • Coral Springs, Florida, United States, 33065
        • Research Site
      • Gainesville, Florida, United States, 32653
        • Research Site
      • Jacksonville, Florida, United States, 32204
        • Research Site
      • Jacksonville, Florida, United States, 32225
        • Research Site
      • Lake Mary, Florida, United States, 32746
        • Research Site
      • Merritt Island, Florida, United States, 32953
        • Research Site
      • Miami, Florida, United States, 33156
        • Research Site
      • New Port Richey, Florida, United States, 34655
        • Research Site
      • Orange Park, Florida, United States, 32003
        • Research Site
      • Orange Park, Florida, United States, 32073
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Palm Beach Gardens, Florida, United States, 33410
        • Research Site
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Research Site
      • Clarkston, Georgia, United States, 30021
        • Research Site
      • College Park, Georgia, United States, 30349
        • Research Site
      • Hinesville, Georgia, United States, 31313
        • Research Site
      • Jesup, Georgia, United States, 31545
        • Research Site
      • Marietta, Georgia, United States, 30062
        • Research Site
      • Royston, Georgia, United States, 30662
        • Research Site
      • Snellville, Georgia, United States, 30078
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60614
        • Research Site
      • Crystal Lake, Illinois, United States, 60014
        • Research Site
      • Evergreen Park, Illinois, United States, 60805
        • Research Site
      • Libertyville, Illinois, United States, 60048
        • Research Site
      • Oak Lawn, Illinois, United States, 60453
        • Research Site
      • Park Ridge, Illinois, United States, 60068
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Research Site
      • Indianapolis, Indiana, United States, 46256
        • Research Site
      • Jeffersonville, Indiana, United States, 47130
        • Research Site
      • New Albany, Indiana, United States, 47150
        • Research Site
      • Sellersburg, Indiana, United States, 47172
        • Research Site
      • South Bend, Indiana, United States, 46601
        • Research Site
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Research Site
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kansas
      • Topeka, Kansas, United States, 66604
        • Research Site
      • Wichita, Kansas, United States, 67226
        • Research Site
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Research Site
      • Louisville, Kentucky, United States, 40202
        • Research Site
      • Louisville, Kentucky, United States, 40207
        • Research Site
      • Louisville, Kentucky, United States, 40205
        • Research Site
      • Owensboro, Kentucky, United States, 42303
        • Research Site
      • Somerset, Kentucky, United States, 42503
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Research Site
      • Shreveport, Louisiana, United States, 71103
        • Research Site
      • Shreveport, Louisiana, United States, 71101
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
      • Brockton, Massachusetts, United States, 02302
        • Research Site
      • Framingham, Massachusetts, United States, 01702
        • Research Site
      • Pittsfield, Massachusetts, United States, 01201
        • Research Site
      • Westford, Massachusetts, United States, 01886
        • Research Site
      • Woburn, Massachusetts, United States, 01801
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Research Site
      • Bingham Farms, Michigan, United States, 48025
        • Research Site
      • Niles, Michigan, United States, 49120
        • Research Site
      • Stevensville, Michigan, United States, 49127
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Research Site
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Research Site
      • Jackson, Mississippi, United States, 39216
        • Research Site
      • Newton, Mississippi, United States, 39345
        • Research Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Research Site
      • Joplin, Missouri, United States, 64804
        • Research Site
      • North Kansas City, Missouri, United States, 64116
        • Research Site
      • St. Joseph, Missouri, United States, 64507
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Research Site
      • Omaha, Nebraska, United States, 68131
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89107
        • Research Site
    • New Jersey
      • Butler, New Jersey, United States, 07405
        • Research Site
      • Neptune, New Jersey, United States, 07753
        • Research Site
      • New Brunswick, New Jersey, United States, 08901
        • Research Site
      • Paterson, New Jersey, United States, 07503
        • Research Site
      • Princeton, New Jersey, United States, 08540
        • Research Site
      • Toms River, New Jersey, United States, 08753
        • Research Site
      • Vineland, New Jersey, United States, 08360
        • Research Site
      • Woodcliff Lake, New Jersey, United States, 07677
        • Research Site
    • New York
      • Bronx, New York, United States, 10467
        • Research Site
      • Brooklyn, New York, United States, 11201
        • Research Site
      • Brooklyn, New York, United States, 11203
        • Research Site
      • Brooklyn, New York, United States, 11219
        • Research Site
      • Brooklyn, New York, United States, 1285301
        • Research Site
      • Buffalo, New York, United States, 14222
        • Research Site
      • Commack, New York, United States, 11725
        • Research Site
      • Jamaica, New York, United States, 11432
        • Research Site
      • Jericho, New York, United States, 11753
        • Research Site
      • Liverpool, New York, United States, 13088
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • Nanuet, New York, United States, 10954
        • Research Site
      • New Hyde Park, New York, United States, 11040
        • Research Site
      • Rochester, New York, United States, 14618
        • Research Site
      • Syracuse, New York, United States, 13210
        • Research Site
      • Utica, New York, United States, 13502
        • Research Site
      • Valley Stream, New York, United States, 11580
        • Research Site
    • North Carolina
      • Albemarle, North Carolina, United States, 28001
        • Research Site
      • Asheville, North Carolina, United States, 28803
        • Research Site
      • Boone, North Carolina, United States, 28607
        • Research Site
      • Clyde, North Carolina, United States, 28721
        • Research Site
      • Morganton, North Carolina, United States, 28655
        • Research Site
      • Raleigh, North Carolina, United States, 27609
        • Research Site
      • Raliegh, North Carolina, United States, 27615
        • Research Site
      • Trinity, North Carolina, United States, 27370
        • Research Site
      • Winston-Salem, North Carolina, United States, 27157
        • Research Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Research Site
      • Cleveland, Ohio, United States, 44109
        • Research Site
      • Cleveland, Ohio, United States, 44221
        • Research Site
      • Coal Grove, Ohio, United States, 45638
        • Research Site
      • Columbus, Ohio, United States, 43219
        • Research Site
      • Fairfield, Ohio, United States, 45014
        • Research Site
      • Huber Heights, Ohio, United States, 45424
        • Research Site
      • Kent, Ohio, United States, 44240
        • Research Site
      • Lancaster, Ohio, United States, 43130
        • Research Site
      • Massillon, Ohio, United States, 44646
        • Research Site
      • Toledo, Ohio, United States, 43608
        • Research Site
      • Youngstown, Ohio, United States, 44501
        • Research Site
      • Youngstown, Ohio, United States, 44505
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73139
        • Research Site
      • Tulsa, Oklahoma, United States, 74127
        • Research Site
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Research Site
      • Gresham, Oregon, United States, 97030
        • Research Site
      • McMinnville, Oregon, United States, 97128
        • Research Site
    • Pennsylvania
      • Hanover, Pennsylvania, United States, 17331
        • Research Site
      • Kittanning, Pennsylvania, United States, 16201
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19116
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15202
        • Research Site
      • Sellersville, Pennsylvania, United States, 18960
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
      • Providence, Rhode Island, United States, 02905
        • Research Site
    • South Carolina
      • Barnwell, South Carolina, United States, 29812
        • Research Site
      • Charleston, South Carolina, United States, 29425
        • Research Site
      • Charleston, South Carolina, United States, 29406
        • Research Site
      • Cheraw, South Carolina, United States, 29520
        • Research Site
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Research Site
      • Kingsport, Tennessee, United States, 37660
        • Research Site
      • Lebanon, Tennessee, United States, 37087
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
      • Tullahoma, Tennessee, United States, 37388
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Carrollton, Texas, United States, 75010
        • Research Site
      • Fort Worth, Texas, United States, 76102
        • Research Site
      • Houston, Texas, United States, 77030
        • Research Site
      • Houston, Texas, United States, 77054
        • Research Site
      • Houston, Texas, United States, 77087
        • Research Site
      • Lubbock, Texas, United States, 79424
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
      • San Antonio, Texas, United States, 78212
        • Research Site
      • San Antonio, Texas, United States, 78217
        • Research Site
      • San Antonio, Texas, United States, 78273
        • Research Site
      • Smithville, Texas, United States, 78957
        • Research Site
      • Sugar Land, Texas, United States, 77479
        • Research Site
      • Tomball, Texas, United States, 77375
        • Research Site
    • Utah
      • St. George, Utah, United States, 84790
        • Research Site
      • West Jordan, Utah, United States, 84084
        • Research Site
    • Virginia
      • Alexandria, Virginia, United States, 22302
        • Research Site
      • Chesapeake, Virginia, United States, 23320
        • Research Site
      • Fairfax, Virginia, United States, 22031
        • Research Site
      • Glen Allen, Virginia, United States, 23060
        • Research Site
      • Midlothian, Virginia, United States, 23113
        • Research Site
      • Norfolk, Virginia, United States, 23507
        • Research Site
      • Richmond, Virginia, United States, 23225
        • Research Site
      • Richmond, Virginia, United States, 23219
        • Research Site
      • Springfield, Virginia, United States, 22150
        • Research Site
      • Vienna, Virginia, United States, 22180
        • Research Site
    • Washington
      • Centralia, Washington, United States, 98531
        • Research Site
      • Spokane, Washington, United States, 99204
        • Research Site
      • Woodinville, Washington, United States, 98072
        • Research Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Research Site
    • Wisconsin
      • LaCrosse, Wisconsin, United States, 54601
        • Research Site
      • Madison, Wisconsin, United States, 537924108
        • Research Site
      • Milwaukee, Wisconsin, United States, 53226
        • Research Site
      • Monroe, Wisconsin, United States, 53566
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature babies at birth - (32-35 WGA)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
32 to 35 WGA Infants less than six months of age by RSV season peak.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011
Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of RSV-associated emergency department (ED) visits during the RSV season
Time Frame: 2009-2010; 2010- 2011
2009-2010; 2010- 2011
Rate of RSV-associated hospitalization during the RSV season
Time Frame: 2009-2010; 2010-2011
2009-2010; 2010-2011
Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits
Time Frame: 2009-2010; 2010-2011
2009-2010; 2010-2011
Rate of risk factors for RSV infection
Time Frame: 2009-2010; 2010-2011
2009-2010; 2010-2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: Jessie Groothuis, MD, MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI-MA213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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