Multicenter randomized placebo controlled trial of therapy with intravenous immunoglobulin in decreasing mortality due to neonatal sepsis.

OBJECTIVE: To determine whether therapy with intravenous immunoglobulin G (IVIG) would decrease mortality in neonatal sepsis. SETTING: Three tertiary care neonatal intensive care units in the city of Bangalore. METHODS: All neonates admitted to the Neonatal Intensive Care Units with the clinical diagnosis of sepsis and having at least C-reactive protein and one other rapid diagnostic criteria positive were enrolled. Neonates with a birth weight of less than 1000 g and those with any major congenital malformation were excluded. The neonates were randomized to receive 1 g/kg of IVIG on three consecutive days or an equivalent amount of placebo. The rest of the treatment including antibiotics and supportive care was as per the treating physician's decision. The main outcome variable was survival. RESULTS: The trial was carried out over a period of 8 months and recruited 58 neonates. Seven neonates who qualified but did not receive either IVIG or placebo were taken into a separate control group, and one baby who received only one dose of IVIG was excluded from the analysis. Twenty-five neonates were enrolled into the IVIG arm and 25 in the placebo arm. The neonates in the therapy and placebo groups were comparable in terms of birth weight (2144+/-675 g vs. 2072+/-682 g), gestation (37.0+/-3.56 vs. 35.8+/-3.52 weeks), sex distribution, duration of stay, and number requiring ventilation. The placebo group had a significantly higher number of babies with positive blood culture. Seven babies in each group died (p>0.05). There was no significant benefit in using IVIG (OR 1.0; 95% CI 0.25-4.07) (p = 0.74). CONCLUSION: In the sample studied therapy with IVIG did not reduce mortality in neonatal sepsis

Clinical profile and management of symptomatic patent ductus arteriosus in premature infants.

Twenty cases of symptomatic patent ductus arteriosus (PDA) in preterm inborn infants were studied retrospectively. The diagnostic criteria were a systolic or a systolodiastolic murmur, tachycardia (greater than 160 per minute), hyperdynamic precordium, collapsing arterial pulses, cardiomegaly or a need for intermittent positive pressure ventilation or continuous distending airway pressure. The incidence was found to be 2.48/1000 live births and 1.5% of SCBU admission. All babies were less than 35 weeks gestation and 18/20 weighed less than 1750 g at birth. Ten babies were treated with indomethacin (0.2 mg/kg) and two of these babies died before the course of treatment was completed. Ten babies were treated with conservative therapy. They could not be administered indomethacin because two died of fulminant sepsis soon after the diagnosis was made; two babies had sepsis and DIC but recovered from it, three had thrombocytopenia, one had azotemia, two babies had hyperbilirubinemia requiring exchange transfusion. The two groups of babies matched in respect to gestational age, sex, age at presentation, birth weight and associated illnesses. Two babies in each group died soon after diagnosis. Of the eight babies in each group, six babies closed the ductus on indomethacin therapy as against two on conservative therapy. This difference was significant (p less than 0.05). The babies who responded to indomethacin were all treated within two weeks of age. None of them showed any complication of drug therapy or recurrence of PDA. We conclude that intragastric indomethacin given early in the management of symptomatic PDA in term infants is a safe and effective modality.