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

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).

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