Short Term Oral Zinc Supplementation among Babies with Neonatal Sepsis for Reducing Mortality and Improving Outcome – A Double-Blind Randomized Controlled Trial
To evaluate the efficacy of short term zinc supplementation on the mortality rate and neurodevelopment outcome in neonates with sepsis at 12 mo corrected age.
The clinical trial was undertaken in the neonatal intensive care unit of JIPMER during the time period from September 2013 through December 2016. Neonates with clinical manifestations of sepsis who exhibited two positive screening tests (microESR, C- reactive protein, band cell count) were included and randomized into no zinc and zinc group. The intervention was zinc sulfate monohydrate given at a dose of 3 mg/kg twice a day orally for 10 d along with standard antibiotics. The no zinc group was on antibiotic treatment. Blood samples from both groups were collected at baseline and after day 10. Babies were carefully discharged from the hospital. The babies were followed up till 12 mo corrected age using DASII (Development Assessment Scale for Indian Infants).
At the time of enrolment, patient characteristics were similar in both the groups. The mortality rate was significantly higher in no zinc compared to zinc group (5 vs. 13; P = 0.04). Although motor development quotient was similar, mental development quotient was significantly better among babies who received zinc supplementation.
Short term zinc supplementation of newborns with sepsis reduces mortality and improves mental development quotient at 12 mo of age.
KeywordsNeonatal sepsis Zinc Outcome Mortality Neurodevelopment
The authors acknowledge the support of Mr. K.T. Harichandrakumar and Mr. V. Saravana Kumar, Department of Medical Biometrics and Informatics, JIPMER in statistical analysis. They thank Dr. Toteja, Indian Council of Medical Research (ICMR), New Delhi for helping them in analysing serum zinc levels.
BVB and BDB set the framework for this study design. NB has interpreted the results and written the manuscript. CC assessed the neurological outcome of the babies. BVB, MGS and SCP revised the final version of the manuscript.
Compliance with Ethical Standards
Conflict of Interest
Source of Funding
Indian Council of Medical Research (ICMR) and JIPMER provided financial support for the study.
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