title: Controlled trial to evaluate protection of high-risk infants against respiratory syncytial virus disease by using standard intravenous immune globulin.
abstract: We performed a randomized, controlled trial of intravenous immune globulin (respiratory syncytial virus [RSV] neutralizing [Nt] antibody titer of 1:950 in 5% solution) to evaluate protection against RSV-induced disease over two respiratory virus seasons. Forty-nine children (mean age at enrollment, 4.5 months) with severe congenital heart disease or bronchopulmonary dysplasia were randomized as follows. Twenty-four patients were followed as controls and received no immune globulin. Twenty-five patients received monthly infusions of immune globulin at a dose of 500 mg/kg of body weight. There was a similar distribution between groups of patients with heart disease and bronchopulmonary dysplasia. There were 12 culture-proven RSV infections, 6 in the prophylaxis group and 6 in the control group. There was a trend toward less severe RSV illness in immune globulin recipients, as measured by length of hospitalization. Four of the six immune globulin recipients were hospitalized for a total of 35 days (mean, 8.8 +/- 5.0 days) because of RSV illness, in contrast to 51 hospital days (mean, 12.8 +/- 7.6 days) among RSV-infected controls. We conclude that monthly infusions of standard immune globulin containing RSV Nt antibodies may be safely administered to high-risk children, but that standard intravenous immune globulin does not contain sufficient RSV Nt antibody titer to fully protect against severe RSV illness.
authors.affiliation: Department of Pediatric Infectious Disease, New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02155.
authors.forename: H C
authors.initials: HC
authors.lastname: Meissner
authors.forename: D R
authors.initials: DR
authors.lastname: Fulton
authors.forename: J R
authors.initials: JR
authors.lastname: Groothuis
authors.forename: R L
authors.initials: RL
authors.lastname: Geggel
authors.forename: G R
authors.initials: GR
authors.lastname: Marx
authors.forename: V G
authors.initials: VG
authors.lastname: Hemming
authors.forename: T
authors.initials: T
authors.lastname: Hougen
authors.forename: D R
authors.initials: DR
authors.lastname: Snydman
mesh_terms: D006801:Humans; D007070:Immunoglobulin A / Q000032:analysis; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000517:prevention & control; D007262:Infusions, Intravenous; D011292:Premedication; D012136:Respiratory Syncytial Viruses; D012141:Respiratory Tract Infections / Q000382:microbiology / Q000517:prevention & control*; D010253:Respirovirus Infections / Q000517:prevention & control*; D012307:Risk Factors
chemical_list: D007070:Immunoglobulin A; D016756:Immunoglobulins, Intravenous