PEDIATRICS Vol. 99 No. 3 March 1997, pp. 454-461
Respiratory Syncytial Virus (RSV) Immune Globulin Intravenous Therapy for RSV Lower Respiratory Tract Infection in Infants and Young Children at High Risk for Severe RSV Infections
Received Oct 10, 1996; accepted Dec 19, 1996.
,
,,,
From * Children's Hospital National Medical Center, Washington,
DC; Vanderbilt University Children's Hospital, Nashville,
Tennessee; § Children's Hospital of Buffalo; Children's Hospital,
Denver, Colorado; ¶ New England Medical Center, Boston, Massachusetts;
# Uniformed Services University of the Health Sciences, Bethesda,
Maryland; ** University of Rochester Medical Center, Rochester, New
York; Albany Medical College; §§ West Virginia University School
of Medicine Health Sciences Center, Morgantown; || Children's Mercy
Hospital, Kansas City, Missouri; and ¶¶ MedImmune Inc, Gaithersburg,
Maryland.
Objectives. To evaluate the efficacy of high-titer intravenous respiratory syncytial virus immune globulin (RSVIG) in the treatment of children at high risk for severe RSV infection who were hospitalized with proven RSV.
Methods. Infants and young children younger than 2 years with bronchopulmonary dysplasia, chronic lung disease, congenital heart disease, or prematurity (<32 weeks' gestational age), hospitalized with a history of lower respiratory tract infection (LRI) of less than 4 days, were enrolled in this study. Patients were randomized in a blinded fashion to receive either 1500 mg/kg RSVIG or placebo in equal volumes. They were evaluated daily for safety and respiratory scores and for RSV nasal shedding.
Results. One hundred seven high-risk children were
randomized
54 in the RSVIG group and 53 in the placebo group. Of these children, 51 in each group were considered evaluable. Children with
pulmonary disease, congenital heart disease, or prematurity were
equally distributed between the two treatment groups. However, two
important differences were found in baseline variables between the two
groups: there were more patients in the placebo group who had histories
of previous LRI and there was a trend toward more severe disease at
study entry in the RSVIG group. This was manifested by a higher entry
respiratory score in the RSVIG group than in the placebo group
(3.4 ± 0.2 vs 3.1 ± .01). A higher proportion of children
in the RSVIG group (47%) than in the placebo group (28%) required
intensive care at entry and mechanical ventilation at study entry (31%
RSVIG-treated vs 18% placebo-treated patients). No significant
difference was found between groups in the mean unadjusted duration of
hospitalization (RSVIG group, 9.10 ± 1.18 days; control group,
8.17 ± 1.08 days). When the mean was adjusted for entry
respiratory score, likewise, no difference was observed between each
group (8.41 ± 0.97 vs 8.89 ± .99 days). The lack of
efficacy observed in the study primary endpoint was observed in all
diagnostic groups. No differences between the RSVIG and placebo groups
were observed in the following secondary endpoints: duration of
intensive care unit stay, duration of intensive care unit stay for RSV,
mechanical ventilation, or supplemental oxygen. No significant
differences in adverse events were reported in the RSVIG group (16 children) when compared with the control group (10 children).
Conclusion. RSVIG treatment was safe but not efficacious in the treatment of children with bronchopulmonary dysplasia, congenital heart disease, or premature gestation who were hospitalized with RSV LRI.
Key words: respiratory syncytial virus, bronchiolitis, lower respiratory tract, infection, respiratory syncytial virus immune globulin.
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