Indian Pediatr. 2012 Oct 5. pii: S097475591200127. [Epub ahead of print]

Role of Zinc In Neonatal Sepsis: A Double Blinded, Randomized, Placebo Controlled Trial.

Mehta K, Bhatta NK, Majhi S, Shrivastava MK, Singh RR.

Source: Departments of Pediatrics and Adolescent Medicine and *Biochemistry, B.P. Koirala Institute of Health Sciences, Dharan, Nepal. Correspondence to: Dr. Rupa Rajbhandari Singh, Department of Pediatrics and Adolescent Medicine, B.P. Koirala Institute of Health Sciences, Dharan, Nepal.

Abstract

OBJECTIVE: To study the role of Zinc in the treatment of neonatal sepsis.

DESIGN: Double blinded, randomized, placebo controlled trial.

SETTING: B.P. Koirala Institute of Health Sciences, Dharan, Nepal. (Tertiary Care Hospital).

PARTICIPANTS: 614 neonates with Probable Neonatal Sepsis, randomized to receive Zinc (Drug group, n = 307) or Placebo (Placebo group, n =307), in addition to standard antibiotic therapy and supportive care.

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 in mortality rate (drug group-9.77% vs. placebo group-7.81%; P=0.393), mean duration of hospital stay (drug group-142.85±69.41 hrs, vs. placebo group-147.99±73.13 hrs; P=0.841), and requirement of higher lines of antibiotic therapy (drug group-13.35% vs. placebo group-12.05%, P=0.628) were found 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. More trials and subsequently meta-analyses are required to clarify the role of zinc in the treatment of neonatal sepsis.

PMID: 23255688 [PubMed - as supplied by publisher]