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.
Brief Title
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants
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).
* 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).
Completion Date
Completion Date Type
Actual
Conditions
Respiratory Syncytial Virus Hospitalizations
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
RSV
RSVH
Infant
Gestational Age
wGA
PRETERM
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
12 Months
NCT Id
NCT02273882
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D4800L00009
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
A composite outcome of burden of illness (BOI) associated with hospitalization for RSV in terms of clinical, humanistic and health economic outcomes.
Outcome Measure
Burden of illness (BOI) associated with hospitalization for RSV
Outcome Time Frame
4 Months (Additionally up to 12 Months in Season 1 only)
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Infants born at 29 to 35 wGA not receiving RSV prophylaxis hospitalized for RSV at less than 12 months of age
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
1
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Iona Munjal
Investigator Email
imunjal@montefiore.org
Investigator Phone