1279. 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
Session: Poster Abstract Session: Clinical Infectious Diseases: Respiratory Infections
Friday, October 28, 2016
Room: Poster Hall
Posters
  • 1279_IDWPOSTER_SENTINEL1_10.12.16.pdf (329.6 kB)
  • Background: In 2014, the Committee on Infectious Diseases recommended against the use of respiratory syncytial virus immunoprophylaxis (RSV IP) among otherwise healthy preterm infants born at 29–35 weeks’ gestational age (wGA). The SENTINEL1 observational study was designed to characterize RSV hospitalizations (RSVHs) among US preterm infants born at 29–35 wGA not receiving RSV IP.

    Methods: At participating sites (n=43 in 2014–2015 and n=41 in 2015–2016), all laboratory-confirmed RSVHs among preterm infants 29–35 wGA <12 months of age, hospitalized ≥24 hours during the 2014–2015 and 2015–2016 RSV seasons, and who did not receive RSV IP within 35 days before the onset of RSV disease symptoms were systematically identified and characterized (NCT02273882). Data from Season 2 were available through Mar 31, 2016. Exploratory statistical comparisons were conducted using the Cochran-Mantel-Haenszel test.

    Results: Characteristics of identified infants with community-acquired RSVHs are presented in the Table.

    Table.

     

    Season 1 (Oct 1, 2014–Apr 30, 2015)

    (n=702)

    Season 2 (Oct 1, 2015–Mar 31, 2016)

    (n=617)

    Variable

    29–32

    wGA

    (n=237)

    33–34

    wGA

    (n=283)

    35

    wGA

    (n=182)

    29–32

    wGA

    (n=189)

    33–34

    wGA

    (n=259)

    35

    wGA

    (n=169)

    Median (IQR) age at admission, mo

    3 (2–5)

    2 (1–4)

    2 (1–5)

    3 (2–6)

    2 (1–5)

    2 (1–5)

    Median (IQR) hospital LOS, d

    6 (3–12)

    6 (3–10)

    5 (3–7)

    5 (3–10)

    5 (3–10)

    4 (3–8)

    ICU admission, n (%)

    115 (49)

    117 (43)

    56 (31)

    87 (46)

    126 (49)

    82 (49)

    Median (IQR) ICU LOS, d

    8 (3–14)

    6 (3–12)

    5 (3–9)

    5 (3–9)

    6 (3–11)

    5 (3–8)

    IMV among all admissions, n (%)

    58 (24)

    53 (20)

    23 (13)

    38 (20)

    54 (21)

    30 (18)

    Death, n

    1

    0

    0

    1

    0

    0

    ICU=intensive care unit; IMV=invasive mechanical ventilation; IQR=interquartile range; LOS=length of stay

    Among all infants 29–35 wGA in both seasons, ICU admission occurred more frequently for infants <3 mo vs 3 to <12 mo (56% vs 34%) as did IMV (30% vs 10%); P<0.001 for both.

    Conclusion: Study results from two RSV seasons were consistent and demonstrated that among preterm infants 29–35 wGA not receiving RSV IP, RSV illness can be severe with frequent ICU admissions and IMV, particularly among infants <3 mo.

    This study was sponsored by AstraZeneca

    Evan J. Anderson, MD1, John P. Devincenzo, MD2, Paul A. Checchia, MD3, Michael L. Forbes, MD4, Natasha Halasa, MD, MPH, FPIDS5,6, Leonard R. Krilov, MD7, Pia S. Pannaraj, MD, MPH8, Eric A. Simões, MB, BS, DCH, MD9, Joseph B. Domachowske II, MD, FIDSA, FPIDS10, Claudia M. Espinosa, MD, MSc11, Robert C. Welliver Sr., MD12, Leslie I. Wolkoff, MD13, Scott J. McBride, MA14, Kimmie K. McLaurin, MS15, Veena R. Kumar, MD, MPH16 and Christopher S. Ambrose, MD, MBA16, (1)Pediatrics and Medicine, Emory University School of Medicine, Atlanta, GA, (2)Department of Pediatrics, University of Tennessee Center for Health Sciences and the CFRI at Le Bonheur Children's Hospital, Memphis, TN, (3)Department of Pediatrics, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX, (4)Department of Pediatrics, Akron Children’s Hospital, Akron, OH, (5)School of Medicine, Vanderbilt University, Nashville, TN, (6)Vanderbilt University Medical Center, Nashville, TN, (7)Department of Pediatrics, Winthrop University Hospital, Mineola, NY, (8)Department of Pediatrics and Molecular Immunology and Microbiology, Children's Hospital Los Angeles, Los Angeles, CA, (9)Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO, (10)Pediatrics, Microbiology and Immunology, SUNY Upstate Medical University, Syracuse, NY, (11)University of Louisville, Louisville, KY, (12)Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, (13)Connecticut Children's Medical Center, Hartford, CT, (14)Department of Statistics, United BioSource Corporation, Ann Arbor, MI, (15)Department of Health Economics and Outcomes Research, AstraZeneca, Gaithersburg, MD, (16)Department of US Medical Affairs, AstraZeneca, Gaithersburg, MD

    Disclosures:

    E. J. Anderson, AbbVie: Consultant , Consulting fee
    MedImmune: Grant Investigator , Editorial support and Research support

    J. P. Devincenzo, AstraZeneca: Consultant , Grant Investigator and Scientific Advisor , Grant recipient and Research support

    P. A. Checchia, AstraZeneca: Investigator , Grant recipient
    AbbVie: Scientific Advisor , Consulting fee

    M. L. Forbes, AstraZeneca: Consultant , Investigator and Speaker's Bureau , Research grant

    N. Halasa, Pfizer: Grant Investigator , Research grant
    Biocryst: Grant Investigator , Research support
    AstraZeneca: Grant Investigator , Research support
    Baxter: Grant Investigator , Research grant

    L. R. Krilov, AstraZeneca: Investigator , Grant recipient
    Regeneron: Investigator , Grant recipient

    P. S. Pannaraj, AstraZeneca: Grant Investigator , Research support

    E. A. Simões, MedImmune: Grant Investigator , Grant recipient
    AbbVie: Scientific Advisor , Grant recipient

    J. B. Domachowske II, AstraZeneca: Grant Investigator , Research grant
    Regeneron: Investigator , Research grant

    C. M. Espinosa, Cempra: Investigator , I do not receive direct reimbursement for research support, but as part of my obligations as a PI, I have participated in investigator meetings. The company pays for expenses during those meetings (flight fare, hotel and food). and Research support
    AstraZeneca: Investigator , I do not receive direct reimbursement for research support, I have attended investigator meetings. The company pays for expenses during those meetings and Research support
    The Medicines Company: Investigator , I do not receive direct for resreimbursement earch support, I have not attended investigator meetings, but I may in the future . and Research support
    Regeneron Pharmaceuticals, Inc.: Investigator , I do not receive direct reimbursement for research support, I have not attended investigator meetings, but I may in the future and the company might pay for expenses during those meetings and Research support
    Multiple Industry sponsors: Investigator , I am an unfunded sub-investigator for multiple clinical trials perform at the KCPC and KCPCRU. Among those companies are Merck, Sanofi Pasteur, Novartis, GlaxoSmithKline, and Pfizer. I may participate in investigator meetings and any of these companies ma and Research support

    R. C. Welliver Sr., None

    L. I. Wolkoff, None

    S. J. McBride, AstraZeneca: CRO , CRO

    K. K. McLaurin, AstraZeneca: Employee , employee granted stock and Salary

    V. R. Kumar, AstraZeneca: Employee , Salary and Stock

    C. S. Ambrose, AstraZeneca: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.