New Data Shows Frequent ICU Admissions from Severe RSV Disease among Preterm Infants in the First Three Months of Life
October 28 2016 - 8:00AM
Business Wire
SENTINEL1 Respiratory Syncytial Virus (RSV)
Data presented at IDWeek 2016
AstraZeneca today announced data from the
second season of its SENTINEL1 study, the largest study ever to
examine laboratory-confirmed respiratory syncytial virus
hospitalizations (RSVH) among US preterm infants 29-35 weeks
gestational age (wGA) who were <12 months of age at the time of
their RSVH admission.1,2 Infants enrolled did not receive
immunoprophylaxis (IP) within 35 days before the onset of RSV
disease symptoms during the 2014-2015 or 2015-2016 RSV seasons.1,2
Study results were presented at IDWeek 2016 in New Orleans, LA.
RSV is a leading cause of hospitalization for babies in the US
during their first year of life, creating a high unmet medical
need, especially among high-risk infants.3
At the 42 hospitals involved in the study during the 2015-2016
RSV season, 678 infants were found to have been hospitalized with
community-acquired RSV, and 78% of these infants were <6 months
of age when hospitalized.2
Among those hospitalized, intensive care unit (ICU) admission
was required for 48% of infants and invasive mechanical ventilation
(IMV) was required for 19% of infants.2 ICU admission and IMV were
most frequent in infants <3 months of age.2
- Among infants 29-32 wGA and <3
months, 69% were admitted to the ICU and 36% required IMV2
- Among infants 33-34 wGA and <3
months, 60% were admitted to the ICU and 30% required IMV2
- Among infants 35 wGA and <3 months,
53% were admitted to the ICU and 24% required IMV2
The 2015-2016 study results are similar to those observed in the
2014-2015 RSV season of the SENTINEL1 study which found that RSV
hospitalizations, ICU admission and IMV are more frequent in
preterm infants at a younger chronologic age.2
Lead study investigator, Evan J. Anderson, MD, Associate
Professor of Pediatrics at Emory University School of Medicine,
stated: “SENTINEL1 highlights the physical, emotional and financial
burden severe RSV disease may have on high-risk infants and their
caregivers. The data show the broader impact of the RSV disease
burden on US preterm infants that should be considered.”
Emotional Burden High Among Parents and Caregivers
In addition to the important insights regarding increased rates
of ICU admission and IMV from SENTINEL1, a separate analysis of the
data highlights the extended impact RSVH has on parents and
caregivers, an area where there are currently few contemporary
data.
Self-reported responses were collected from parents and
caregivers participating in the SENTINEL1 study and found that RSVH
have a considerable impact on caregivers and their infants,
including continued medical concerns, emotional burden and
financial implications, that continued through one month
post-discharge.4
- For the 212 infants whose
parents/guardians enrolled them in the study to provide detailed
data regarding their experience, 86% of caregivers provided
responses at discharge, with the highest percentage reporting
impact on emotions (54%), routine disruptions (36%), family
relationships (31%) and financial burdens (30%) at discharge4
- At one month after discharge,
caregivers expressed the highest impact on emotions (33%), routine
disruptions (20%) and medical concerns (13%)4
The growing body of evidence from SENTINEL1 and other studies
will help the medical community better understand the current
impact of severe RSV disease on US preterm infants and their
families.
Details around these data presentations can be accessed below or
on the IDWeek 2016 website here.
- SENTINEL1: An Ongoing Multicenter
Observational Study of Respiratory Syncytial Virus Hospitalizations
Among US Infants Born at 29–35 Weeks’ Gestational Age Not Receiving
Immunoprophylaxis in 2014–2016 (Clinical Infectious Diseases:
Respiratory Infections Session, Poster Number 1279, Friday, October
28, 12:30-2:00 PM ET)
- “Caregiver Impact of Respiratory
Syncytial Virus Hospitalizations among US Preterm Infants 29–35
Weeks’ Gestational Age” (Clinical Infectious Diseases: Respiratory
Infections Session, Poster Number 1287, Friday, October 28,
12:30-2:00 PM ET)
NOTES TO EDITORS
About SENTINEL1
SENTINEL1 is an ongoing retrospective and prospective study
aimed to characterize RSV-confirmed hospitalizations among US
preterm infants born at 29-35 weeks gestation who did not receive
immunoprophylaxis within 35 days before the onset of RSV disease
symptoms during the 2014-2015 and 2015-2016 RSV season.1 The
eligibility criteria for SENTINEL1 include preterm infants 29-35
wGA who were <12 months of age at the time of their RSVH
admission and had been hospitalized for ≥24 hours due to
laboratory-confirmed RSV disease.1 SENTINEL1 evaluated gestational
age, chronologic age, hospital length of stay (LOS), ICU admission,
ICU LOS, need for IMV, and survival.1
About IDWeek
IDWeek 2016™ is an annual meeting of the Infectious Diseases
Society of America (IDSA), the Society for Healthcare Epidemiology
of America (SHEA), the HIV Medicine Association (HIVMA) and the
Pediatric Infectious Diseases Society (PIDS). With the theme
“Advancing Science, Improving Care,” IDWeek features the latest
science and bench-to-bedside approaches in prevention, diagnosis,
treatment, and epidemiology of infectious diseases, including HIV,
across the lifespan. IDWeek 2016 takes place October 26-30 at the
Ernest N. Morial Convention Center in New Orleans. For more
information, visit www.idweek.org.
About RSV
RSV is a contagious, seasonal respiratory virus that nearly 100%
of children will contract, at varying levels of severity, by the
age of two and most will recover from within 1-2 weeks.5,6,7 In
certain high-risk babies, however, RSV can lead to a serious lung
infection and hospitalization.8,9 Preterm infants are at increased
risk of developing severe RSV disease because their lung volume is
significantly less than that of full-term infants, and their
airways are smaller and narrower than those of a baby born at
term.10
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca-us.com and follow us on Twitter
@AstraZenecaUS.
References
- Anderson E, Krilov L, DeVincenzo J, et
al. SENTINEL1: An observational study of respiratory syncytial
virus hospitalizations among US infants born at 29 to 35 weeks’
gestational age not receiving immunoprophylaxis. Am J Perinatol. In
press.
- Anderson EJ, DeVincenzo JP, Checchia
PA, et al. SENTINEL1: An Ongoing Multicenter Observational Study of
Respiratory Syncytial Virus Hospitalizations Among US Infants Born
at 29-35 Weeks’ Gestational Age Not Receiving Immunoprophylaxis in
2014-2016. Poster Number 1279. Poster presented at IDWeek 2016
Meeting, October 26-30, 2016.
- Leader S, Kohlhase K. Respiratory
syncytial virus-coded pediatric hospitalizations, 1997 to 1999.
Pediatr Infect Dis J. 2002; 21:629-632.
- Pokrzywinski RM, Swett LL, Yi J, et al.
Caregiver Impact of Respiratory Syncytial Virus Hospitalizations
among US Preterm Infants 29-35 Weeks’ Gestational Age. Poster
Number 1287. Poster presented at IDWeek 2016 Meeting, October
26-30, 2016.
- Centers for Disease Control and
Prevention. Infection and Incidence.
http://www.cdc.gov/rsv/about/infection.html. Accessed October 14,
2016.
- Glezen WP, Taber LJ, Frank AL, Kasel
JA. Risk of Primary Infection and Reinfection with Respiratory
Syncytial Virus. Am J Dis Child. 1986; 140:543-546.
- Hall CB, Weinberg GA, Iwane MK, et al.
The Burden of Respiratory Syncytial Virus Infection in Young
Children. N Engl J Med. 2009; 360:588-598.
- Boyce TG, et al. Rates of
hospitalizations for respiratory syncytial virus infection among
children in Medicaid. J Pediatr. 2000; 137:865-70.
- Centers for Disease Control and
Prevention. Preterm Birth.
http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm.
Accessed October 14, 2016.
- Langston C, Kida K, Reed M, Thurlbeck
WM. Human lung growth in late gestation and in the neonate. Am Rev
Respir Dis. 1984; 129:607-613.
3301318 10/16
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