Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. The Respiratory Syncytial Virus Immune Globulin Study Group
- PMID: 8413475
- DOI: 10.1056/NEJM199311183292102
Prophylactic administration of respiratory syncytial virus immune globulin to high-risk infants and young children. The Respiratory Syncytial Virus Immune Globulin Study Group
Abstract
Background: Infants with cardiac disease or prematurity are at risk for severe illness caused by respiratory syncytial virus. Immune globulin with a high titer of antibodies against respiratory syncytial virus may offer infants and young children at risk protection 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 prematurity alone (n = 60). Respiratory syncytial virus immune globulin was given monthly to some of these children in either a high dose (750 mg per kilogram of body weight; n = 81) or low dose (150 mg per kilogram; n = 79); 89 controls received no immune globulin. Group assignments were random. Assessments of respiratory illness and management were conducted without knowledge of the children's group assignments.
Results: There were 64 episodes of respiratory syncytial virus infection: 19 in the high-dose group, 16 in the low-dose group, and 29 in the control group. In the high-dose group there were fewer lower respiratory tract infections (7, vs. 20 in the control group; P = 0.01), fewer hospitalizations (6, vs. 18 in the control group; P = 0.02), fewer hospital days (43, vs. 128 in the control group; P = 0.02), fewer days in the intensive care unit (P = 0.05), and less use of ribavirin (P = 0.05). In the low-dose group there was a significant reduction only in the number of days in the intensive care unit (P = 0.03). Adverse events during the 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 the low-dose group, and none in the control group (P = 0.15), but no death was attributed to the use of immune globulin or to illness caused by respiratory syncytial virus.
Conclusions: Administration of high doses of respiratory syncytial virus immune globulin is a safe and effective means of preventing lower respiratory tract infection in infants and young children at high risk for this disease.
Comment in
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A trial of RSV immune globulin in infants and young children: the FDA's view.N Engl J Med. 1994 Jul 21;331(3):203-5. doi: 10.1056/NEJM199407213310315. N Engl J Med. 1994. PMID: 8054049 No abstract available.
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Respiratory syncytial virus--successful immunoprophylaxis at last.N Engl J Med. 1993 Nov 18;329(21):1572-4. doi: 10.1056/NEJM199311183292112. N Engl J Med. 1993. PMID: 8413482 No abstract available.
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Respiratory syncytial virus immune globulin and conflict of interest.N Engl J Med. 1998 Nov 26;339(22):1644. doi: 10.1056/NEJM199811263392216. N Engl J Med. 1998. PMID: 9867534 No abstract available.
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