An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants

Completed

Conditions studied: Respiratory Syncytial Virus Hospitalizations

In brief

Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at up to 12 months of age.

Key facts

Study ID

NCT02273882

Run by

AstraZeneca

People needed

497

Starts

2014-11-17

Expected to finish

2016-08-19

Last updated by the study team

2017-05-23

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Born at 29 to 35 wGA (i.e., 29 weeks, 0 days through 35 weeks, 6 days)
• Laboratory-confirmed, nosocomial or community-acquired RSV disease (RSV can be documented in the outpatient and/or inpatient setting during the illness that resulted in the index hospitalization)
• Hospitalized ≥24 hours for the diagnosed RSV disease (the index RSVH)
• <12 months of age at time of index RSVH admission
• Written informed consent and any locally required authorization (e.g., HIPAA), obtained from the infant's Parent/Guardian

You may not qualify if…

• Receipt of RSV immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index RSVH

Where it is running

• Research Site — Little Rock, Arkansas, United States
• Research Site — Loma Linda, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Hartford, Connecticut, United States
• Research Site — Orlando, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — Reno, Nevada, United States
• Research Site — Atlantic City, New Jersey, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — Paterson, New Jersey, United States
• Research Site — Brooklyn, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Research Site — Mineola, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States

Full record on ClinicalTrials.gov

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