OBJECTIVE: To evaluate the efficacy of oral zinc salt on the incidence of hyperbilirubinemia and need for phototherapy between 25 and 168 h of age in term and late-preterm at-risk neonates cared at a tertiary care hospital in New Delhi, India. METHODS: In all neonates born at ≥35 wks' gestation, serum total bilirubin (STB) was assayed at 24 ± 6 h of age. At-risk neonates, neonates with STB levels ≥6 mg/dL, were given either 10 mg of zinc gluconate salt (n = 148) or placebo (n = 146) in twice daily doses till day seven of age. Jaundice was assessed clinically and STB was measured by spectrophotometry. Neonates were followed up until day seven of age. Primary outcome measure was incidence of hyperbilirubinemia (STB ≥ 15 mg/dl). Secondary outcome measures were mean STB level at 72 ± 12 h of age, proportion of infants requiring phototherapy, and duration there of. RESULTS: Risk factors for hyperbilirubinemia, including male gender, gestational age, birth-weight, incidence of birth trauma, ABO incompatibility, hyperbilirubinemia in previous sib, etc. were comparable in zinc and placebo groups. The incidence of hyperbilirubinemia was comparable in both the groups (17.9% vs 19.1% in zinc and placebo groups respectively; OR = 0.95, 95% CI: 0.50 to 1.67; P = 0.92). The requirement of phototherapy (14.5% and 12.0% in zinc and placebo groups respectively; OR = 1.24, 95% CI: 0.95 to 2.6; P = 0.54) was comparable in both the groups; however, duration of phototherapy was shorter in zinc group (duration in hours, 22.8 ± 19.4 vs 35.6 ± 16.1 in zinc and placebo group respectively; mean difference = -12.8, 95% CI: -24.73 to -0.92; P = 0.04). There was no difference in the mean STB levels at 72 ± 12 h of age between zinc and placebo groups (mean difference in mg/dL: 0.20, 95% CI: 1.0 to -0.64). No significant adverse effects related to oral zinc administration were noted. CONCLUSIONS: Twice daily administration of oral zinc in a dose of 10 mg/day does not reduce the incidence of hyperbilirubinemia in at-risk term and late-preterm neonates during first wk of age.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of oral zinc salt on the incidence of hyperbilirubinemia and need for phototherapy between 25 and 168 h of age in term and late-preterm at-risk neonates cared at a tertiary care hospital in New Delhi, India. METHODS: In all neonates born at ≥35 wks' gestation, serum total bilirubin (STB) was assayed at 24 ± 6 h of age. At-risk neonates, neonates with STB levels ≥6 mg/dL, were given either 10 mg of zinc gluconate salt (n = 148) or placebo (n = 146) in twice daily doses till day seven of age. Jaundice was assessed clinically and STB was measured by spectrophotometry. Neonates were followed up until day seven of age. Primary outcome measure was incidence of hyperbilirubinemia (STB ≥ 15 mg/dl). Secondary outcome measures were mean STB level at 72 ± 12 h of age, proportion of infants requiring phototherapy, and duration there of. RESULTS: Risk factors for hyperbilirubinemia, including male gender, gestational age, birth-weight, incidence of birth trauma, ABO incompatibility, hyperbilirubinemia in previous sib, etc. were comparable in zinc and placebo groups. The incidence of hyperbilirubinemia was comparable in both the groups (17.9% vs 19.1% in zinc and placebo groups respectively; OR = 0.95, 95% CI: 0.50 to 1.67; P = 0.92). The requirement of phototherapy (14.5% and 12.0% in zinc and placebo groups respectively; OR = 1.24, 95% CI: 0.95 to 2.6; P = 0.54) was comparable in both the groups; however, duration of phototherapy was shorter in zinc group (duration in hours, 22.8 ± 19.4 vs 35.6 ± 16.1 in zinc and placebo group respectively; mean difference = -12.8, 95% CI: -24.73 to -0.92; P = 0.04). There was no difference in the mean STB levels at 72 ± 12 h of age between zinc and placebo groups (mean difference in mg/dL: 0.20, 95% CI: 1.0 to -0.64). No significant adverse effects related to oral zinc administration were noted. CONCLUSIONS: Twice daily administration of oral zinc in a dose of 10 mg/day does not reduce the incidence of hyperbilirubinemia in at-risk term and late-preterm neonates during first wk of age.