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.