The aim of this study was to investigate whether intravenous immunoglobulin (IVIG) can prevent sepsis in premature newborn infants. The study group consisted of 80 preterm newborn infants, who were divided into two groups: 40 preterm newborns received IVIG prophylactically (group A) and the control group (group B, n = 40) did not receive IVIG. IVIG was given at a dose of 500 mg/kg to infants. weighing greater than 1500 g, and 700 mg/kg to those weighing less than 1500 g at birth on days one, two and eight of life. By two, eight and 12 days of age, the treatment group had significantly greater IgG concentrations than the control group. Mortality was 7.5 percent (3/40) in group A and 27.5 percent (11/40) in group B (p < 0.01). Bacteremia was determined in three blood cultures in group A and eight in group B, particularly S.aureus and S.enteritis.
[Show abstract][Hide abstract] ABSTRACT: Immunoglobulin given to preterm babies provides minimal benefit in preventing infection from hospital-borne diseases. A nosocomial infection is an infection whose development is favoured by a hospital environment. Preterm babies (born before 34 weeks) are particularly at risk and a dose of immunoglobulin can be given by injection to provide the necessary antibodies and prevent infection. The review of trials found evidence that giving immunoglobulin to preterm babies helps reduce the chance of infection in hospital, but only to a very small degree, and found no adverse effects except pain of the injection.
[Show abstract][Hide abstract] ABSTRACT: Prophylactic administration of intravenous immunoglobulin has been inconsistent in reducing the risk of sepsis in very low birth weight (VLBW) infants presumably because of varying titers of organism specific IgG antibodies. INH-A21 is an intravenous immunoglobulin from donors with high titers of antistaphylococcal antibodies. This dose-ranging study explored safety and preliminary activity of INH-A21 for prevention of staphylococcal sepsis in VLBW infants.
This was a multicenter, double blind, group-sequential study. Infants with birth weights 500-1250 g were randomized to receive up to 4 doses of placebo, 250 mg/kg, 500 mg/kg or 750 mg/kg INH-A21. Safety and frequencies of sepsis were compared across treatment groups.
All treatment groups had similar mean gestational age, birth weight, Apgar score and maternal use of antibiotics. Randomizations to 250 mg/kg (N = 94) and 500 mg/kg (N = 96) doses were terminated after interim analyses demonstrated a low probability of finding a difference when compared with placebo. Infants randomized to the INH-A21 750 mg/kg group (N = 157) had fewer episodes of Staphylococcus aureus sepsis [relative risk (RR), 0.37; 95% confidence interval (CI), 0.12-1.12; P = 0.14], candidemia (RR 0.34; 95% CI 0.09-1.22; P = 0.09) and mortality (RR 0.64; 95% CI 0.25-1.61; P = 0.27) when compared with the placebo-treated cohort (N = 158). No dose-related trends were observed for adverse events or morbidities associated with prematurity.
INH-A21 750 mg/kg demonstrated potential to reduce sepsis caused by S. aureus, candidemia and mortality in VLBW infants. Although statistical significance was not reached, based on the magnitude of the estimated differences, the efficacy and safety of INH-A21 750 mg/kg should be evaluated in an adequately powered, well-controlled study.
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