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A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants . National Institute of Child Health and Human Development Neonatal Research Network . BACKGROUND Nosocomial infections are a major cause of morbidity and mortality in premature infants . As a rule , their low serum gamma globulin levels at birth subsequently decline to hypogammaglobulinemic values ; hence , prophylactic administration of intravenous immune globulin may reduce the rate of hospital-acquired infections . METHODS In this prospective , multicenter , two-phase controlled trial , 2416 infants were stratified according to birth weight ( 501 to 1000 g and 1001 to 1500 g ) and randomly assigned to an intravenous immune globulin group ( n = 1204 ) or a control group ( n = 1212 ) . Control infants were given placebo infusions during phase 1 of the study ( n = 623 ) but were not given any infusions during phase 2 ( n = 589 ) . Infants weighing 501 to 1000 g at birth were given 900 mg of immune globulin per kilogram of body weight , and infants weighing 1001 to 1500 g at birth were given a dose of 700 mg per kilogram . The immune globulin infusions were repeated every 14 days until the infants weighed 1800 g , were transferred to another center , died , or were sent home from the hospital . RESULTS Nosocomial infections of the blood , meninges , or urinary tract occurred in 439 of the 2416 infants ( 18.2 percent ) : 208 ( 17.3 percent ) in the immune globulin group and 231 ( 19.1 percent ) in the control group ( relative risk , 0.91 ; 95 percent confidence interval , 0.77 to 1.08 ) . Septicemia occurred in 15.5 percent of the immune globulin recipients and 17.2 percent of the controls . During phase 1 the rate of nosocomial infections was 13.4 percent in the immune globulin group and 17.8 percent in the control group ; the respective rates during phase 2 were 21.0 percent and 20.4 percent . The predominant organisms included gram-positive cocci ( 53.0 percent ) , gram-negative bacilli ( 22.4 percent ) , and candida species ( 16.0 percent ) . Adverse reactions were rarely observed during the infusions . Immune globulin therapy had no effect on respiratory distress syndrome , bronchopulmonary dysplasia , intracranial hemorrhage , the duration of hospitalization , or mortality . The incidence of necrotizing enterocolitis was 12.0 percent in the immune globulin group and 9.5 percent in the control group . CONCLUSIONS Prophylactic use of intravenous immune globulin failed to reduce the incidence of hospital-acquired infections in very-low-birth-weight infants .
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Intervention_Pharmacological
immune globulin
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Intervention_Pharmacological
immune globulin
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Intervention_Pharmacological
intravenous immune globulin group
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Intervention_Control
control group
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Intervention_Pharmacological
immune globulin
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Outcome_Physical
nosocomial infections
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Outcome_Physical
Nosocomial infections
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Outcome_Physical
Nosocomial infections of the blood , meninges , or urinary tract
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Outcome_Physical
Septicemia
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Outcome_Physical
nosocomial infections
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Outcome_Adverse-effects
Adverse reactions
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Outcome_Physical
respiratory distress syndrome , bronchopulmonary dysplasia , intracranial hemorrhage
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Outcome_Other
the duration of hospitalization
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Outcome_Mortality
mortality
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Outcome_Physical
necrotizing enterocolitis
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Outcome_Physical
hospital-acquired infections
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Participant_Condition
very-low-birth-weight
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Participant_Age
infants
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Participant_Condition
premature
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Participant_Age
infants
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Participant_Sample-size
2416
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Participant_Age
infants
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Participant_Age
Infants
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Participant_Age
infants