Sepsis Clinical Trial
Official title:
Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
A controlled clinical trial was conducted at eight participating centers between January 1, 1988, and March 31, 1991. Patients were randomly assigned to an intravenous immune globulin group or a control group. There were two phases to the study (see below). During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.
Although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase,
nosocomial infections remain a major cause of morbidity and mortality. Prolonged
hospitalization with exposure to resistant organisms and multiple invasive procedures, in the
presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired
infections. Prior studies testing the ability of intravenous immune globulin to prevent
nosocomial infections in premature infants have varied in design and sample size. Despite
differences in the rates of observed infection, immune globulin preparations, doses, and
infusion intervals, a meta-analysis of published reports suggests that nosocomial infections
may be diminished by the prophylactic infusion of IgG.
The National Institute of Child Health and Human Development (NICHD) Neonatal Research
Network therefore performed a prospective, multicenter, randomized trial at eight
participating centers to test the hypothesis that the intravenous administration of immune
globulin to infants with birth weights between 501 and 1500g would reduce the incidence of
nosocomial infections.
Patients were randomly assigned to an intravenous immune globulin group or a control group.
During phase 1 the control infants received infusions of placebo. During phase 2 the control
infants received no infusion therapy.
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