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CompletedNCT00983606Updated Nov 14, 2012

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

An observational study in Healthy, sponsored by MedImmune LLC. Completed at 222 sites in United States. Per ClinicalTrials.gov, last updated 2012-11-14.

Sponsored by MedImmune LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Premature babies at birth - (32-35 WGA)

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 1

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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of RSV-associated emergency department (ED) visits during the RSV season

    Time frame: 2009-2010; 2010- 2011

  2. Rate of RSV-associated hospitalization during the RSV season

    Time frame: 2009-2010; 2010-2011

  3. Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits

    Time frame: 2009-2010; 2010-2011

  4. Rate of risk factors for RSV infection

    Time frame: 2009-2010; 2010-2011

07

Study locations

222 sites
  • Research Site
    Birmingham, Alabama 35209, United States
  • Research Site
    Birmingham, Alabama 35235, United States
  • Research Site
    Dothan, Alabama 36305, United States
  • Research Site
    Greenville, Alabama 36037, United States
  • Research Site
    Mobile, Alabama 36604, United States
  • Research Site
    Prattville, Alabama 36066, United States
  • Research Site
    Scottsboro, Alabama 35768, United States
  • Research Site
    Selma, Alabama 36701, United States
  • Research Site
    Sylacauga, Alabama 35150, United States
  • Research Site
    Tuscaloosa, Alabama 35401, United States
  • Research Site
    Chandler, Arizona 85224, United States
  • Research Site
    Mesa, Arizona 85206, United States
  • Research Site
    Phoenix, Arizona 85008, United States
  • Research Site
    Prescott, Arizona 86301, United States
  • Research Site
    Scottsdale, Arizona 85258, United States
  • Research Site
    Bentonville, Arkansas 72712, United States
  • Research Site
    Benton, Arkansas 72019, United States
  • Research Site
    Fort Smith, Arkansas 72901, United States
  • Research Site
    Jonesboro, Arkansas 72401, United States
  • Research Site
    Little Rock, Arkansas 72205, United States
  • Research Site
    Anaheim, California 92804, United States
  • Research Site
    Bakersfield, California 93311, United States
  • Research Site
    Chico, California 95926, United States
  • Research Site
    Fountain Valley, California 92708, United States
  • Research Site
    Fresno, California 93710, United States
  • Research Site
    Fresno, California 93726, United States
  • Research Site
    Granada Hills, California 91344, United States
  • Research Site
    Hollister, California 95023, United States
  • Research Site
    Huntington Beach, California 92647, United States
  • Research Site
    La Jolla, California 92037, United States
  • Research Site
    Long Beach, California 90806, United States
  • Research Site
    Los Angeles, California 90033, United States
  • Research Site
    Los Angeles, California, United States
  • Research Site
    National City, California 91950, United States
  • Research Site
    San Diego, California 92120, United States
  • Research Site
    San Jose, California 95128, United States
  • Research Site
    Santa Ana, California 92705, United States
  • Research Site
    Ventura, California 93003, United States
  • Research Site
    Aurora, Colorado 80045, United States
  • Research Site
    Centennial, Colorado 80015, United States
  • Research Site
    Lakewood, Colorado 80214, United States
  • Research Site
    Longmont, Colorado 80501, United States
  • Research Site
    Louisville, Colorado 80027, United States
  • Research Site
    Newark, Delaware 19711, United States
  • Research Site
    Washington, District of Columbia 20007, United States
  • Research Site
    Cantonment, Florida 32533, United States
  • Research Site
    Cocoa Beach, Florida 32931, United States
  • Research Site
    Coral Gables, Florida 33146, United States
  • Research Site
    Coral Springs, Florida 33065, United States
  • Research Site
    Gainesville, Florida 32653, United States
  • Research Site
    Jacksonville, Florida 32204, United States
  • Research Site
    Jacksonville, Florida 32225, United States
  • Research Site
    Lake Mary, Florida 32746, United States
  • Research Site
    Merritt Island, Florida 32953, United States
  • Research Site
    Miami, Florida 33156, United States
  • Research Site
    New Port Richey, Florida 34655, United States
  • Research Site
    Orange Park, Florida 32003, United States
  • Research Site
    Orange Park, Florida 32073, United States
  • Research Site
    Orlando, Florida 32806, United States
  • Research Site
    Palm Beach Gardens, Florida 33410, United States
  • Research Site
    Alpharetta, Georgia 30005, United States
  • Research Site
    Clarkston, Georgia 30021, United States
  • Research Site
    College Park, Georgia 30349, United States
  • Research Site
    Hinesville, Georgia 31313, United States
  • Research Site
    Jesup, Georgia 31545, United States
  • Research Site
    Marietta, Georgia 30062, United States
  • Research Site
    Royston, Georgia 30662, United States
  • Research Site
    Snellville, Georgia 30078, United States
  • Research Site
    Stockbridge, Georgia 30281, United States
  • Research Site
    Chicago, Illinois 60612, United States
  • Research Site
    Chicago, Illinois 60614, United States
  • Research Site
    Crystal Lake, Illinois 60014, United States
  • Research Site
    Evergreen Park, Illinois 60805, United States
  • Research Site
    Libertyville, Illinois 60048, United States
  • Research Site
    Oak Lawn, Illinois 60453, United States
  • Research Site
    Park Ridge, Illinois 60068, United States
  • Research Site
    Fort Wayne, Indiana 46804, United States
  • Research Site
    Indianapolis, Indiana 46256, United States
  • Research Site
    Jeffersonville, Indiana 47130, United States
  • Research Site
    New Albany, Indiana 47150, United States
  • Research Site
    Sellersburg, Indiana 47172, United States
  • Research Site
    South Bend, Indiana 46601, United States
  • Research Site
    Dubuque, Iowa 52001, United States
  • Research Site
    Iowa City, Iowa 52242, United States
  • Research Site
    Topeka, Kansas 66604, United States
  • Research Site
    Wichita, Kansas 67226, United States
  • Research Site
    Bardstown, Kentucky 40004, United States
  • Research Site
    Louisville, Kentucky 40202, United States
  • Research Site
    Louisville, Kentucky 40205, United States
  • Research Site
    Louisville, Kentucky 40207, United States
  • Research Site
    Owensboro, Kentucky 42303, United States
  • Research Site
    Somerset, Kentucky 42503, United States
  • Research Site
    Baton Rouge, Louisiana 70806, United States
  • Research Site
    Shreveport, Louisiana 71101, United States
  • Research Site
    Shreveport, Louisiana 71103, United States
  • Research Site
    Baltimore, Maryland 21201, United States
  • Research Site
    Boston, Massachusetts 02111, United States
  • Research Site
    Brockton, Massachusetts 02302, United States
  • Research Site
    Framingham, Massachusetts 01702, United States
  • Research Site
    Pittsfield, Massachusetts 01201, United States

Showing the first 100 of 222 sites.

08

References and documents

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. Erratum In: PLoS One. 2016 Dec 13;11(12):e0168882. doi: 10.1371/journal.pone.0168882. 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00983606
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Sep 24, 2009
Start date
Sep 2009
Primary completion
Jun 2011
Completion
Jul 2011
Last update
Nov 14, 2012

Study contacts

Jessie Groothuis, MD
study director · MedImmune LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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