An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
SENTINEL1
The SENTINEL 1 Study: An Observational, Non-Interventional Study in the United States to Characterize Respiratory Syncytial Virus Hospitalizations Among Infants Born at 29 to 35 Weeks Gestational Age Not Receiving Immunoprophylaxis
1 other identifier
observational
497
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedStudy Start
First participant enrolled
November 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2016
CompletedMay 23, 2017
May 1, 2017
1.8 years
October 17, 2014
May 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Burden of illness (BOI) associated with hospitalization for RSV
A composite outcome of burden of illness (BOI) associated with hospitalization for RSV in terms of clinical, humanistic and health economic outcomes.
4 Months (Additionally up to 12 Months in Season 1 only)
Study Arms (1)
Preterm Infants 29-35 Weeks Gestation <12 months of age
Preterm Infants 29-35 Weeks Gestation \<12 months of age
Eligibility Criteria
Infants born at 29 to 35 wGA not receiving RSV prophylaxis hospitalized for RSV at less than 12 months of age
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (44)
Research Site
Little Rock, Arkansas, United States
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Loma Linda, California, United States
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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, 11501, 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christopher Ambrose, MD
AstraZeneca
- STUDY DIRECTOR
Veena Kumar, MD, MPH
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2014
First Posted
October 24, 2014
Study Start
November 17, 2014
Primary Completion
August 19, 2016
Study Completion
August 19, 2016
Last Updated
May 23, 2017
Record last verified: 2017-05