Prophylactic Administration of Respiratory Syncytial Virus Immune Globulin to High-Risk Infants and Young Children
Jessie R. Groothuis, Eric Simoes, Myron J. Levin, Caroline B. Hall, Christine E. Long, William J. Rodriguez, Julita Arrobio, H. Cody Meissner, David R. Fulton, Robert C. Welliver, Debra A. Tristram, George R. Siber, Gregory A. Prince, Mark Van Raden, Val G. Hemming, for The Respiratory Syncytial Virus Immune Globulin Study Group
Background Infants with cardiac disease or prematurity are atrisk for severe illness caused by respiratory syncytial virus.Immune globulin with a high titer of antibodies against respiratorysyncytial virus may offer infants and young children at riskprotection from this serious, common respiratory illness.
Methods We studied 249 infants and young children (mean age,eight months) who had bronchopulmonary dysplasia due to prematurity(n = 102), congenital heart disease (n = 87), or prematurityalone (n = 60). Respiratory syncytial virus immune globulinwas given monthly to some of these children in either a highdose (750 mg per kilogram of body weight; n = 81) or a low dose(150 mg per kilogram; n = 79); 89 controls received no immuneglobulin. Group assignments were random. Assessments of respiratoryillness and management were conducted without knowledge of thechildren's group assignments.
Results There were 64 episodes of respiratory syncytial virusinfection: 19 in the high-dose group, 16 in the low-dose group,and 29 in the control group. In the high-dose group there werefewer lower respiratory tract infections (7, vs. 20 in the controlgroup; P = 0.01), fewer hospitalizations (6, vs. 18 in the controlgroup; P = 0.02), fewer hospital days (43, vs. 128 in the controlgroup; P = 0.02), fewer days in the intensive care unit (P =0.05), and less use of ribavirin (P = 0.05). In the low-dosegroup there was a significant reduction only in the number ofdays in the intensive care unit (P = 0.03). Adverse events duringthe 580 infusions were generally mild and included fluid overload(in five children), oxygen desaturation (eight), and fever (six).Six children died: three in the high-dose group, three in thelow-dose group, and none in the control group (P = 0.15), butno death was attributed to the use of immune globulin or toillness caused by respiratory syncytial virus.
Conclusions Administration of high doses of respiratory syncytialvirus immune globulin is a safe and effective means of preventinglower respiratory tract infection in infants and young childrenat high risk for this disease.
Source Information
From the Department of Pediatrics, Divisions of Neonatology, Infectious Diseases, and Cardiology, University of Colorado School of Medicine and the Children's Hospital, Denver (J.R.G., E.A.F.S., M.J.L.); the Department of Pediatrics, Strong Memorial Hospital and University of Rochester School of Medicine, Rochester, N.Y. (C.B.H., C.E.L.); the Children's National Medical Center, Washington, D.C. (W.J.R., J.A.); the Divisions of Cardiology and Infectious Diseases, Floating Hospital for Infants and Children, New England Medical Center Hospitals-Tufts University, Boston (H.C.M., D.R.F.); the Division of Infectious Diseases, State University of New York Medical Center Children's Hospital, Buffalo (R.C.W., D.A.T.); Massachusetts Public Health Biologic Laboratories, Boston (G.R.S.); Virion Systems, Rockville, Md. (G.A.P.); the National Institute of Allergy and Infectious Disease, Bethesda, Md. (M.V.R.); and the Department of Pediatrics, F. Edward Hebert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Md. (V.G.H.). The members of the Respiratory Syncytial Virus Immune Globulin Study Group are listed in the Appendix.
Address reprint requests to Dr. Groothuis at the Children's Hospital, 1056 E. 19th Ave., B070, Denver, CO 80218.
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