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An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants (SENTINEL1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273882
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease
Respiratory Syncytial Virus Hospitalizations

Detailed Description:

This surveillance study will enroll approximately 500 eligible infants from approximately 40 study sites in the US, hospitalized for laboratory-confirmed, nosocomial or community-acquired RSV disease during the study eligibility period of 1 October 2014 through 30 April 2015 (Season 1) and 1 October 2015 through 30 April 2016 (Season 2). During these eligibility periods, infants may be enrolled:

  • 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).

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Study Type : Observational
Actual Enrollment : 497 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : November 17, 2014
Actual Primary Completion Date : August 19, 2016
Actual Study Completion Date : August 19, 2016

Group/Cohort
Preterm Infants 29-35 Weeks Gestation <12 months of age
Preterm Infants 29-35 Weeks Gestation <12 months of age



Primary Outcome Measures :
  1. Burden of illness (BOI) associated with hospitalization for RSV [ Time Frame: 4 Months (Additionally up to 12 Months in Season 1 only) ]
    A composite outcome of burden of illness (BOI) associated with hospitalization for RSV in terms of clinical, humanistic and health economic outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants born at 29 to 35 wGA not receiving RSV prophylaxis hospitalized for RSV at less than 12 months of age
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273882


Locations
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United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
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
United States, Colorado
Research Site
Aurora, Colorado, United States
United States, Connecticut
Research Site
Hartford, Connecticut, United States
United States, Florida
Research Site
Orlando, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
Research Site
Evanston, Illinois, United States
United States, Kansas
Research Site
Kansas City, Kansas, United States
United States, Kentucky
Research Site
Louisville, Kentucky, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Mississippi
Research Site
Jackson, Mississippi, United States
United States, Nevada
Research Site
Reno, Nevada, United States
United States, New Jersey
Research Site
Atlantic City, New Jersey, United States
Research Site
Morristown, New Jersey, United States
Research Site
Paterson, New Jersey, United States
United States, New York
Research Site
Brooklyn, New York, United States
Winthrop University Hospital
Mineola, New York, United States, 11501
Research Site
Mineola, New York, United States
Research Site
New York, New York, United States
Research Site
Rochester, New York, United States
Research Site
Syracuse, New York, United States
Research Site
The Bronx, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
Research Site
Greenville, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
United States, Ohio
Research Site
Akron, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Dayton, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Site
Hershey, Pennsylvania, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, South Dakota
Research Site
Sioux Falls, South Dakota, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Galveston, Texas, United States
Research Site
Houston, Texas, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
United States, Wisconsin
Research Site
Marshfield, Wisconsin, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Christopher Ambrose, MD AstraZeneca
Study Director: Veena Kumar, MD, MPH AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02273882    
Other Study ID Numbers: D4800L00009
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Keywords provided by AstraZeneca:
RSV
RSVH
Infant
Gestational Age
wGA
PRETERM
Additional relevant MeSH terms:
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Virus Diseases