Oral zinc supplementation for reducing mortality in probable neonatal sepsis: A double blind randomized placebo controlled trial

To study the role of Zinc in the treatment of neonatal sepsis. Double blind, randomized, placebo controlled trial. Tertiary Care Hospital. 614 neonates with probable neonatal sepsis. The drug group (n=307) received 1mg/kg/day of elemental zinc, and placebo group (n=307) received the placebo, in addition to antibiotic therapy and supportive care, till the final outcome (discharge/death). Decrease in mortality rates (primary outcome), duration of hospital stay and need of higher lines of antibiotic therapy (secondary outcomes) were tested. Baseline characteristics of the two groups were similar. No statistically significant differences between drug and placebo group were found in mortality rate (9.77% vs 7.81 %; P=0.393), mean duration of hospital stay (142.85 +/- 69.41 hrs, vs. 147.99 +/- 73.13 hrs; P=0.841), and requirement of higher lines of antibiotic therapy (13.35% vs 12.05%, P=0.628) after supplementation. This study does not report decrease in mortality rates, duration of hospital stay and requirement of higher lines of antibiotic therapy following zinc supplementation in neonatal sepsis.