SENTINEL1: Two-Season Study of Respiratory Syncytial Virus Hospitalizations among U.S. Infants Born at 29 to 35 Weeks' Gestational Age Not Receiving Immunoprophylaxis

Evan J. Anderson; John P. DeVincenzo; Eric A. F. Simões; Leonard R. Krilov; Michael L. Forbes; Pia S. Pannaraj; Claudia M. Espinosa; Robert C. Welliver; Leslie I. Wolkoff; Ram Yogev; Paul A. Checchia; Joseph B. Domachowske; Natasha Halasa; Scott J. McBride; Veena R. Kumar; Kimmie K. McLaurin; Christopher P. Rizzo; Christopher S. Ambrose

doi:10.1055/s-0039-1681014

American Journal of Perinatology, Inhaltsverzeichnis

CC BY-NC-ND 4.0 · Am J Perinatol 2020; 37(04): 421-429
DOI: 10.1055/s-0039-1681014

Original Article

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

SENTINEL1: Two-Season Study of Respiratory Syncytial Virus Hospitalizations among U.S. Infants Born at 29 to 35 Weeks' Gestational Age Not Receiving Immunoprophylaxis

Evan J. Anderson

¹Departments of Pediatrics and Medicine, Emory University School of Medicine, Atlanta, Georgia

,

John P. DeVincenzo

²Departments of Pediatrics and Microbiology, Immunology, and Biochemistry, University of Tennessee School of Medicine, Memphis, Tennessee

,

Eric A. F. Simões

³Section of Pediatric Infectious Disease, University of Colorado School of Medicine, Colorado School of Public Health, Children’s Hospital Colorado, Aurora, Colorado

,

Leonard R. Krilov

⁴Division of Pediatric Infectious Disease, Children's Medical Center, NYU-Winthrop Hospital, Mineola, New York

,

Michael L. Forbes

⁵Pediatric Critical Care Medicine, Akron Children's Hospital, Akron, Ohio

,

Pia S. Pannaraj

⁶Division of Infectious Diseases, Children's Hospital Los Angeles, Los Angeles, California, Keck School of Medicine, University of Southern California, Los Angeles, California

,

Claudia M. Espinosa

⁷Pediatric Infectious Diseases, University of Louisville, Louisville, Kentucky

,

Robert C. Welliver

⁸Pediatric Infectious Diseases, Children’s Hospital at OU Medical Center, Oklahoma City, Oklahoma

,

Leslie I. Wolkoff

⁹Division of Neonatology, Connecticut Children's Medical Center, Hartford, Connecticut

,

Ram Yogev

¹⁰Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

,

Paul A. Checchia

¹¹Cardiac Intensive Care, Texas Children's Hospital, Houston, Texas

,

Joseph B. Domachowske

¹²Pediatrics: Infectious Disease, SUNY Upstate Medical University, Syracuse, New York

,

Natasha Halasa

¹³Pediatric Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee

,

Scott J. McBride

¹⁴United BioSource Corporation, Ann Arbor, Michigan

,

Veena R. Kumar

¹⁵AstraZeneca, Gaithersburg, Maryland

,

Kimmie K. McLaurin

¹⁵AstraZeneca, Gaithersburg, Maryland

,

Christopher P. Rizzo

¹⁵AstraZeneca, Gaithersburg, Maryland

,

Christopher S. Ambrose

¹⁵AstraZeneca, Gaithersburg, Maryland

› Institutsangaben

Abstract

Objective The SENTINEL1 observational study characterized confirmed respiratory syncytial virus hospitalizations (RSVH) among U.S. preterm infants born at 29 to 35 weeks' gestational age (wGA) not receiving respiratory syncytial virus (RSV) immunoprophylaxis (IP) during the 2014 to 2015 and 2015 to 2016 RSV seasons.

Study Design All laboratory-confirmed RSVH at participating sites during the 2014 to 2015 and 2015 to 2016 RSV seasons (October 1–April 30) lasting ≥24 hours among preterm infants 29 to 35 wGA and aged <12 months who did not receive RSV IP within 35 days before onset of symptoms were identified and characterized.

Results Results were similar across the two seasons. Among infants with community-acquired RSVH (N = 1,378), 45% were admitted to the intensive care unit (ICU) and 19% required invasive mechanical ventilation (IMV). There were two deaths. Infants aged <6 months accounted for 78% of RSVH observed, 84% of ICU admissions, and 91% requiring IMV. Among infants who were discharged from their birth hospitalization during the RSV season, 82% of RSVH occurred within 60 days of birth hospitalization discharge.

Conclusion Among U.S. preterm infants 29 to 35 wGA not receiving RSV IP, RSVH are often severe with almost one-half requiring ICU admission and about one in five needing IMV.

Keywords

respiratory syncytial virus - infants - palivizumab - immunoprophylaxis - hospitalizations

Volltext

Referenzen

References
1 Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr 2003; 143 (5, Suppl): S127-S132
2 Mandell GL, Bennett JE, Dolin R. Mandell, Douglas and Bennett's Principles and Practice of Infectious Diseases, 4th ed. New York: Churchill Livingstone; 1995
3 Jain S, Williams DJ, Arnold SR. , et al; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med 2015; 372 (09) 835-845
4 Boyce TG, Mellen BG, Mitchel Jr EF, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr 2000; 137 (06) 865-870
5 Langley GF, Anderson LJ. Epidemiology and prevention of respiratory syncytial virus infections among infants and young children. Pediatr Infect Dis J 2011; 30 (06) 510-517
6 Stevens TP, Sinkin RA, Hall CB, Maniscalco WM, McConnochie KM. Respiratory syncytial virus and premature infants born at 32 weeks' gestation or earlier: hospitalization and economic implications of prophylaxis. Arch Pediatr Adolesc Med 2000; 154 (01) 55-61
7 Horn SD, Smout RJ. Effect of prematurity on respiratory syncytial virus hospital resource use and outcomes. J Pediatr 2003; 143 (5, Suppl): S133-S141
8 Law BJ, Langley JM, Allen U. , et al. The Pediatric Investigators Collaborative Network on Infections in Canada study of predictors of hospitalization for respiratory syncytial virus infection for infants born at 33 through 35 completed weeks of gestation. Pediatr Infect Dis J 2004; 23 (09) 806-814
9 DeVincenzo JP, McClure MW, Symons JA. , et al. Activity of oral ALS-008176 in a respiratory syncytial virus challenge study. N Engl J Med 2015; 373 (21) 2048-2058
10 DeVincenzo JP, Whitley RJ, Mackman RL. , et al. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med 2014; 371 (08) 711-722
11 Simões EA, DeVincenzo JP, Boeckh M. , et al. Challenges and opportunities in developing respiratory syncytial virus therapeutics. J Infect Dis 2015; 211 (Suppl. 01) S1-S20
12 IMpact RSV-Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998; 102: 531-537
13 Blanken MO, Rovers MM, Molenaar JM. , et al; Dutch RSV Neonatal Network. Respiratory syncytial virus and recurrent wheeze in healthy preterm infants. N Engl J Med 2013; 368 (19) 1791-1799
14 Anderson EJ, Carosone-Link P, Yogev R, Yi J, Simões EAF. Effectiveness of palivizumab in high-risk Infants and children: a propensity score weighted regression analysis. Pediatr Infect Dis J 2017; 36 (08) 699-704
15 American Academy of Pediatrics Committee on Infectious Diseases and Committee of Fetus and Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IGIV. Pediatrics 1998; 102 (05) 1211-1216
16 American Academy of Pediatrics Committee on Infectious Diseases and Committee on Fetus and Newborn. Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections. Pediatrics 2003; 112 (6 Pt 1): 1442-1446
17 American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics 2006; 118 (04) 1774-1793
18 Committee on Infectious Diseases. From the American Academy of Pediatrics: policy statements--modified recommendations for use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics 2009; 124 (06) 1694-1701
19 American Academy of Pediatrics. Respiratory syncytial virus. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS. , eds. Red Book: 2012 Report of the Committee on Infectious Diseases, 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012: 609-618
20 American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 2014; 134 (02) 415-420
21 Boyce TG. More on viral bronchiolitis in children. N Engl J Med 2016; 375 (12) 1199-1200
22 Goldstein M, Merritt TA, Phillips R. , et al. National Perinatal Association 2015 Respiratory Syncytial Virus (RSV) Prevention Guideline. Neonatology Today [serial online]. 2014;9:1–11. Available at: https://www.neonatologytoday.net/issues.php#2014issues . Accessed August 15, 2018
23 Anderson EJ, Krilov LR, DeVincenzo JP. , 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 2017; 34 (01) 51-61
24 Ambrose CS, Anderson EJ, Simões EA. , et al. Respiratory syncytial virus disease in preterm infants in the U.S. born at 32-35 weeks gestation not receiving immunoprophylaxis. Pediatr Infect Dis J 2014; 33 (06) 576-582
25 Helfrich AM, Nylund CM, Eberly MD, Eide MB, Stagliano DR. Healthy late-preterm infants born 33-36+6 weeks gestational age have higher risk for respiratory syncytial virus hospitalization. Early Hum Dev 2015; 91 (09) 541-546
26 Winterstein AG, Knox CA, Kubilis P, Hampp C. Appropriateness of age thresholds for respiratory syncytial virus immunoprophylaxis in moderate-preterm infants: a cohort study. JAMA Pediatr 2013; 167 (12) 1118-1124
27 Rajah B, Sánchez PJ, Garcia-Maurino C, Leber A, Ramilo O, Mejias A. Impact of the updated guidance for palivizumab prophylaxis against respiratory syncytial virus infection: a single center experience. J Pediatr 2017; 181: 183-188
28 Blanken MO, Paes B, Anderson EJ. , et al. Risk scoring tool to predict respiratory syncytial virus hospitalisation in premature infants. Pediatr Pulmonol 2018; 53 (05) 605-612
29 Kong AM, Krilov LR, Fergie J. , et al. The 2014–2015 national impact of the 2014 American Academy of Pediatrics guidance for respiratory syncytial virus immunoprophylaxis on preterm infants born in the United States. Am J Perinatol 2018; 35 (02) 192-200
30 Goldstein M, Krilov LR, Fergie J. , et al. Respiratory syncytial virus hospitalizations among US preterm infants compared with term infants before and after the 2014 American Academy of Pediatrics guidance on immunoprophylaxis: 2012–2016. Am J Perinatol 2018; 35 (14) 1433-1442

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