An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
NCT ID: NCT02273882
Last Updated: 2017-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
497 participants
OBSERVATIONAL
2014-11-17
2016-08-19
Brief Summary
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Detailed Description
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* Prospectively at the time of their index Respiratory Syncytial Virus Hospitalization (RSVH) admission or any time prior to their index RSVH discharge, or
* Retrospectively on the basis of electronic medical record (EMR) review following discharge from the index RSVH.
Regardless of the timing of study enrollment (i.e., in relation to the date of discharge from the index RSVH), sites will identify all infants eligible for study participation, including those treated in the inpatient ward and intensive care unit (ICU). Identification of all potentially eligible infants will be ensured through the review of the EMR, or other local healthcare database deemed appropriate for study purposes by the Study Coordinating Center (SCC).
The clinical, humanistic and health economic outcomes associated with the RSV disease will be characterized in the outpatient and inpatient settings, from the onset of symptoms of RSV disease pre index RSVH to up to 4 months post index RSVH discharge date (additionally to 12 months post index RSVH discharge date in Season 1 only), on the basis of medical records and Parent/Guardian self-report. Information regarding any sequelae associated with the index RSVH, medically-attended wheezing episodes, loss of work productivity and healthcare resource utilization (HRU) related to the management of RSV-related disease will also be collected from the medical records and Parent/Guardian by telephone interview at approximately 1 month and 4 months following discharge from the index RSVH (additionally at 12 months in Season 1 only).
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Preterm Infants 29-35 Weeks Gestation <12 months of age
Preterm Infants 29-35 Weeks Gestation \<12 months of age
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
12 Months
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Ambrose, MD
Role: STUDY_DIRECTOR
AstraZeneca
Veena Kumar, MD, MPH
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Little Rock, Arkansas, United States
Research Site
Loma Linda, California, United States
Research Site
Long Beach, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Aurora, Colorado, United States
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Hartford, Connecticut, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Kansas City, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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Jackson, Mississippi, United States
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Reno, Nevada, United States
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Atlantic City, New Jersey, United States
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Morristown, New Jersey, United States
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Paterson, New Jersey, United States
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Brooklyn, New York, United States
Winthrop University Hospital
Mineola, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Hershey, Pennsylvania, United States
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Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Marshfield, Wisconsin, United States
Countries
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Related Links
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Other Identifiers
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D4800L00009
Identifier Type: -
Identifier Source: org_study_id
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