Banupriya Newton1, Ballambattu Vishnu Bhat2, Benet Bosco Dhas1, Nivedita Mondal1, Sridhar Magadi Gopalakrishna3. 1. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India. 2. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India. drvishnubhat@yahoo.com. 3. Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.
Abstract
OBJECTIVE: To find the effect of zinc supplementation on the outcome of neonatal sepsis at one month of age. METHODS: 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. RESULTS: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)]. CONCLUSIONS:Zinc supplementation in neonates with sepsis improves the neurological status at one month of age although the mortality reduction was not statistically significant.
RCT Entities:
OBJECTIVE: To find the effect of zinc supplementation on the outcome of neonatal sepsis at one month of age. METHODS: 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. RESULTS: 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)]. CONCLUSIONS: Zinc supplementation in neonates with sepsis improves the neurological status at one month of age although the mortality reduction was not statistically significant.
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