Oral Zinc Supplementation for Reducing Mortality in Probable Neonatal Sepsis: A Double Blind Randomized Placebo Controlled Trial.

ABSTRACT

Objective: To study the role of Zinc in the treatment of neonatal sepsis. Design: Double blind, randomized, placebo controlled trial. Setting: Tertiary Care Hospital. Participants: 614 neonates with probable neonatal sepsis. Intervention 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). Outcome Measures: Decrease in mortality rates (primary outcome), duration of hospital stay and need of higher lines of antibiotic therapy (secondary outcomes) were tested. Results: 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. Conclusions: 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.