Effect of Zinc Supplementation on Early Outcome of Neonatal Sepsis - A Randomized Controlled Trial
To find the effect of zinc supplementation on the outcome of neonatal sepsis at one month of age.
This randomized controlled trial was conducted in a tertiary care neonatal unit, enrolling neonates with clinical features of sepsis and positive blood culture or positive sepsis screening tests. The treatment group received 3 mg/kg/twice a day of zinc sulfate monohydrate orally for 10 d along with standard antibiotic therapy. The control group received standard antibiotic treatment without zinc. Samples were collected from both the groups before and after the treatment. Babies were monitored till discharge and followed up as out-patients till one month of age.
Demographic characteristics were similar between the cases and controls. After 10 d of treatment, the mean serum zinc level between the two groups was 737.09 ± 219.97 vs. 801.26 ± 405.56, (p = 0.20). Outcome measures like days of hospital stay (15 vs. 15; p = 0.69) and mortality rate (4.5 % vs. 13.6 %; p = 0.27) were not found to be significantly different between the groups. At one month of age, more number of control neonates had abnormal neurological findings as compared to the zinc supplemented group [(P = 0.02); RR (95%CI) = 0.28 (0.11–0.73)].
Zinc supplementation in neonates with sepsis improves the neurological status at one month of age although the mortality reduction was not statistically significant.
KeywordsNeonatal sepsis Zinc supplementation Mortality Neurological status
The assistance in statistical analysis by Dr. Palanivel and Dr. Divya, Department of P&SM, is acknowledged. The authors are thankful to Dr.Toteja from Indian Council of Medical Research (ICMR), New Delhi for estimating the serum zinc levels.
BBD and BVB designed the study. BN has done laboratory works and drafted the manuscript. NM assessed the neurological outcome of the babies. BVB, SMG and NM reviewed the manuscript. BVB will act as guarantor for the paper.
Conflict of Interest
Source of Funding
Extramural Research Grant, Indian Council of Medical Research (ICMR), New Delhi.
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