Respiratory Syncytial Virus HospitalizationsSENTINEL1NCT02273882
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
An observational study of Respiratory Syncytial Virus Hospitalizations, run by AstraZeneca at 44 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Respiratory Syncytial Virus Hospitalizations
- How many people
- 497 participants
- Where
- 44 sitesUnited States
- Study dates
- 17 Nov 2014to 19 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants born at 29 to 35 wGA not receiving RSV prophylaxis hospitalized for RSV at less than 12 months of age
Who may be able to join
- 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
Who cannot join
- Receipt of RSV immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index RSVH
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Research Site
Akron, Ohio
Research Site
Atlanta, Georgia
Research Site
Atlantic City, New Jersey
Research Site
Aurora, Colorado
Research Site
Boston, Massachusetts
Research Site
Brooklyn, New York
Research Site
Charleston, South Carolina
Research Site
Chicago, Illinois
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Dayton, Ohio
Research Site
Durham, North Carolina
Research Site
Evanston, Illinois
Research Site
Galveston, Texas
Research Site
Greenville, North Carolina
Research Site
Hartford, Connecticut
Research Site
Hershey, Pennsylvania
Research Site
Houston, Texas
Research Site
Jackson, Mississippi
Research Site
Kansas City, Kansas
Research Site
Little Rock, Arkansas
Research Site
Loma Linda, California
Research Site
Long Beach, California
Research Site
Los Angeles, California
Research Site
Louisville, Kentucky
Research Site
Marshfield, Wisconsin
Research Site
Memphis, Tennessee
Winthrop University Hospital
Mineola, New York, 11501
Research Site
Mineola, New York
Research Site
Morristown, New Jersey
Research Site
Nashville, Tennessee
Research Site
New Orleans, Louisiana
Research Site
New York, New York
Research Site
Oklahoma City, Oklahoma
Research Site
Orange, California
Research Site
Orlando, Florida
Research Site
Paterson, New Jersey
Research Site
Raleigh, North Carolina
Research Site
Reno, Nevada
Research Site
Richmond, Virginia
Research Site
Rochester, New York
Research Site
Sioux Falls, South Dakota
Research Site
Syracuse, New York
Research Site
The Bronx, New York
About this study
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
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.
Read the 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).
- Keywords
- RSV, RSVH, Infant, Gestational Age, wGA, PRETERM
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Infants 29-35 Weeks Gestation <12 months of age | Preterm Infants 29-35 Weeks Gestation <12 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 Months (Additionally up to 12 Months in Season 1 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study start17 Nov 2014
- Primary completion19 Aug 2016
- Study completion19 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus HospitalizationsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Ambrose, MD, Study director, AstraZenecaVeena Kumar, MD, MPH, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273882
- Sponsor's protocol ID
- D4800L00009
- Acronym
- SENTINEL1
- Status last verified
- May 2017
- First submitted
- 17 Oct 2014
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02273882
- Acronym / sponsor ID
- SENTINEL1 / D4800L00009
- Keywords
- RSV, RSVH, Infant, Gestational Age, wGA, PRETERM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 19 Aug 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm Infants 29-35 Weeks Gestation <12 months of age | – | –Preterm Infants 29-35 Weeks Gestation <12 months of age |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born at 29 to 35 wGA not receiving RSV prophylaxis hospitalized for RSV at less than 12 months of age
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Receipt of RSV immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index RSVH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Ambrose, MD study director
AstraZeneca
Veena Kumar, MD, MPH study director
AstraZeneca
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Hospitalizations, run by AstraZeneca at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of illness (BOI) associated with hospitalization for RSV (time frame: 4 Months (Additionally up to 12 Months in Season 1 only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.