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

May 22, 2017 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

497

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • 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
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States
        • Research Site
    • Florida
      • Orlando, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Evanston, Illinois, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Research Site
    • Nevada
      • Reno, Nevada, United States
        • Research Site
    • New Jersey
      • Atlantic City, New Jersey, United States
        • Research Site
      • Morristown, New Jersey, United States
        • Research Site
      • Paterson, New Jersey, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • 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
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States
        • Research Site
      • Greenville, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Cincinnati, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Galveston, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
    • Virginia
      • Richmond, Virginia, United States
        • Research Site
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 Months (Additionally up to 12 Months in Season 1 only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Christopher Ambrose, MD, AstraZeneca
  • Study Director: Veena Kumar, MD, MPH, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2014

Primary Completion (Actual)

August 19, 2016

Study Completion (Actual)

August 19, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4800L00009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Syncytial Virus Hospitalizations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe