Intravenous immunoglobulin for sepsis prevention in preterm infants.
ABSTRACT 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.
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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.The Pediatric Infectious Disease Journal 11/2005; 24(10):858-66. · 3.14 Impact Factor
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ABSTRACT: Abstract Objective To systematically review meta-analyses (MAs) and randomised controlled trials (RCTs) of interventions for infants at risk of cerebral palsy (CP) to determine if consensus exists in study end-points. Methods MAs within the "Neonatal" and "Pregnancy and Childbirth" Review Groups in Cochrane Database of Systematic Reviews (to June 2011) were included if they contained risk factors for CP as a study end-point, and were either published in 2010 or 2011 or cited >20 times in Sciverse Scopus. Up to 20 RCTs from each MA were included. Outcome measures, definitions, and cut points for ordinal groupings were extracted from MAs and RCTs and frequencies calculated. Results Twenty-two MAs and 165 RCTs were appraised. High consistency existed in types of outcome domains listed as important in MAs. For 10/16 most frequently cited outcome domains, <50% of RCTs contributed data for meta-analyses. Low consistency in outcome definitions, measures, cut points in RCTs and long term follow-up prohibited data aggregation. Conclusions Variation in outcome measurement and long term follow up has hampered the ability of RCTs to contribute data on important outcomes for CP, resulting in lost opportunities to measure the impact of maternal and neonatal interventions. There is an urgent need for and long term follow up of these interventions and an agreed set of standardised and clinically relevant common data elements for study end-points.Journal of Maternal-Fetal and Neonatal Medicine 10/2014; · 1.21 Impact Factor