HealthyNCT00983606

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

An observational study of Healthy, run by MedImmune LLC at 222 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Healthy
How many people: 3,000 participants
Where: 222 sitesUnited States
Study dates: Sep 2009to Jul 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Premature babies at birth - (32-35 WGA)

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

222 sites in 1 country.

City, postcode or hospital

222 sites in 1 country

United States222 sites

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

Other trials in United States

About this study

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)

Read the 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.

Conditions: Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00983606
Study group	Role	What they receive
1		32 to 35 WGA Infants less than six months of age by RSV season peak.

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR
Measured: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Jul 2011

First posted24 Sep 2009 (estimated)
Study startSep 2009
Primary completionJun 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00983606
Sponsor's protocol ID: MI-MA213
Status last verified: Nov 2012
First submitted: 23 Sep 2009
Last updated: 14 Nov 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 27898687
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.
PubMed 24622396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00983606
Acronym / sponsor ID: MI-MA213
Conditions: Healthy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,000 participants (estimated)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Jun 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 24 Sep 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	–32 to 35 WGA Infants less than six months of age by RSV season peak.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Premature babies at birth - (32-35 WGA)

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
Derived from this study: PubMed 27898687Simoes 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.
Derived from this study: PubMed 24622396Ambrose 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.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessie Groothuis, MD study director

MedImmune LLC

222 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by MedImmune LLC at 222 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 222 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00983606, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.