Ashok Kumar1, Narendra Kumar Bagri, Sriparna Basu, Ravi Kumar Asthana. 1. Departments of Pediatrics and *Botany, Banaras Hindu University, Varanasi, India Correspondence to: Dr Ashok Kumar, Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi 221 005, India. ashokkumar_bhu@hotmail.com.
Abstract
OBJECTIVE: To determine the efficacy of oral zinc for treatment of idiopathic neonatal hyperbilirubinemia in near-term and term (35-41 weeks) neonates. DESIGN: Randomized placebo-controlled trial. SETTING: Tertiary-care teaching hospital. PARTICIPANTS: Eighty newborns with idiopathic neonatal hyperbilirubinemia. INTERVENTION: Neonates were randomized to receive either oral zinc sulfate (10 mg/d) or placebo for 7 days. MAIN OUTCOME MEASURES: Primary: total serum bilirubin levels at 48 (±12) h, 96 (±12) h and 144 (±12) h after intervention. Secondary: duration of phototherapy, and serum zinc and copper levels. RESULTS:Baseline mean (SD) total serum bilirubin levels were 14.8 (3.8) and 14.4 (3.5) mg/dL in zinc and placebo groups, respectively. No significant differences were observed in total bilirubin levels between the two groups after the intervention. Mean (SD) total serum bilirubin levels in zinc and placebo groups were 13.9 (2.5) vs. 13.4 (1.9) mg/dL (mean difference 0.566; 95% CI -0.535, 1.668, P=0.038) at 48 h, 13.1 (2.7) vs. 12.8 (2.3) mg/dL (mean difference 0.234; 95% CI -1.011, 1.479, P =0.708) at 96 h and 8.0 (2.0) vs. 8.6 (1.2) mg/dL (mean difference -0.569, 95% CI -1.382, 0.242, P=0.166) at 144 h. Although the mean duration of phototherapy in the zinc group was less by 21.3 h (95% CI 11.6, 30.9, P=0.052), the difference was not significant. Post-intervention, serum zinc levels were significantly higher in the zinc-supplemented group while serum copper levels were comparable between the two groups. CONCLUSIONS:Oral zinc sulfate, in a dose of 10 mg/day, is not effective in the management of idiopathic neonatal hyperbilirubinemia.
RCT Entities:
OBJECTIVE: To determine the efficacy of oral zinc for treatment of idiopathic neonatal hyperbilirubinemia in near-term and term (35-41 weeks) neonates. DESIGN: Randomized placebo-controlled trial. SETTING: Tertiary-care teaching hospital. PARTICIPANTS: Eighty newborns with idiopathic neonatal hyperbilirubinemia. INTERVENTION: Neonates were randomized to receive either oral zinc sulfate (10 mg/d) or placebo for 7 days. MAIN OUTCOME MEASURES: Primary: total serum bilirubin levels at 48 (±12) h, 96 (±12) h and 144 (±12) h after intervention. Secondary: duration of phototherapy, and serum zinc and copper levels. RESULTS: Baseline mean (SD) total serum bilirubin levels were 14.8 (3.8) and 14.4 (3.5) mg/dL in zinc and placebo groups, respectively. No significant differences were observed in total bilirubin levels between the two groups after the intervention. Mean (SD) total serum bilirubin levels in zinc and placebo groups were 13.9 (2.5) vs. 13.4 (1.9) mg/dL (mean difference 0.566; 95% CI -0.535, 1.668, P=0.038) at 48 h, 13.1 (2.7) vs. 12.8 (2.3) mg/dL (mean difference 0.234; 95% CI -1.011, 1.479, P =0.708) at 96 h and 8.0 (2.0) vs. 8.6 (1.2) mg/dL (mean difference -0.569, 95% CI -1.382, 0.242, P=0.166) at 144 h. Although the mean duration of phototherapy in the zinc group was less by 21.3 h (95% CI 11.6, 30.9, P=0.052), the difference was not significant. Post-intervention, serum zinc levels were significantly higher in the zinc-supplemented group while serum copper levels were comparable between the two groups. CONCLUSIONS: Oral zinc sulfate, in a dose of 10 mg/day, is not effective in the management of idiopathic neonatal hyperbilirubinemia.