Neonatal Jaundice Clinical Trial
Official title:
Effect of Oral Zinc Given Daily Between Days 2 and 7 of Life to Term or Near Term Neonates With Serum Bilirubin Levels of More Than 6 mg/dL at 24 ± 6 Hours of Life on Hyperbilirubinemia and Phototherapy
The purpose of this study is to determine the effect of 10 mg of oral zinc given daily between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of more than 6 mg/dL at 24 ± 6 hours of life on hyperbilirubinemia and phototherapy.
Neonatal hyperbilirubinemia is a common problem occurring in nearly 5-25%
neonates.Inhibition of enterohepatic circulation is one of the therapies being tried for
neonatal jaundice. Studies have suggested that in a neonate, the postulated enterohepatic
pathway is of a magnitude that could be significant in the overall body economy of
bilirubin.Zinc has also been investigated for its role in decreasing the STB levels by
inhibiting enterohepatic circulation. There have been animal studies which have investigated
the role of zinc in decreasing the serum bilirubin levels. The mechanism proposed is that
zinc salts precipitate Unconjugated bilirubin from unsaturated micellar solution of bile
salts and consequently inhibit the enterohepatic circulation of bilirubin. This is the first
study to evaluate the role of zinc in neonatal jaundice.
Study Design: In this randomized placebo controlled clinical trial neonates born at ≥35 wk
of gestation and with total serum bilirubin ≥6mg% were given either zinc gluconate (n = 148)
or placebo (n = 146) in a dose of 10mg per day between days 2 and 7 of life. Jaundice was
assessed clinically and total serum bilirubin estimated using spectrophotometry. Infants
were followed up clinically until discharge and then again at day 7 of life.
Hyperbilirubinemia was defined as total serum bilirubin ≥15mg%.
Results: Incidence of hyperbilirubinemia was comparable in zinc and placebo groups (OR 0.95,
95% CI 0.50-1.67, p=0.92). The requirement of phototherapy was similar in the two groups (OR
0.81, 95% CI 0.41-1.61, p=0.55). The mean hours of phototherapy in the zinc group were also
similar in the two groups (p=0.63). No significant difference with respect to mean levels of
bilirubin (mg/dL) at 72±12 hours of age was observed in two groups(zinc 11.3±3.3,placebo
11.5±3.8,p=0.63). No significant adverse effects of zinc were noted.
Conclusion: Twice daily zinc administration in a dose of 10 mg/day does not reduce
hyperbilirubinemia in at risk neonates in the first week of life.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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