Intravenous immunoglobulin in the treatment of full-term and premature newborns with sepsis.

Blood cultures were performed on 141 newborn infants who had clinical features or laboratory data indicative of sepsis between January 1993 and April 1995. Clinical features included respiratory deterioration, poor activity, abdominal distension and apnea. Abnormal laboratory data included leukocytosis, leukopenia, elevated C-reactive protein values or increased immature neutrophil counts. The 141 neonates with suspected bacterial infections received antibiotic therapy and were randomly divided into two groups. One group received a single dose of 500 mg/kg of intravenous immunoglobulin (IVIG), while the other group received placebo (0.9% sodium chloride). Patients with negative blood cultures were excluded from this study. A total of 56 neonates with positive blood cultures were enrolled in this study. The IVIG-treated group and placebo-treated group consisted of 10 premature and 18 term neonates, respectively. Another 10 healthy premature and healthy 18 term neonates were selected as the control group. Serum IgG values increased significantly 1 and 2 weeks after administration of IVIG in the IVIG-treated group. However, there was no significant difference in the duration of treatment and mortality between the IVIG-treated and placebo-treated groups. Our preliminary observations suggest that administration of 500 mg/kg IVIG to neonates with sepsis had no effect on reducing mortality. In addition, it shortened neither the duration of antibiotic therapy nor hospitalization. No adverse reactions to the IVIG infusions were noted during the study.

RCT Entities:   Population Interventions Outcomes