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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Incidence of hyperbilirubinemia defined as total serum bilirubin more than or equal to 15 mg/dL at anytime between days 2 and 7 of life.
研究概览
简要总结
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.
详细描述
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.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Hours 至 30 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born at ≥35 weeks gestation and with total serum bilirubin ≥ 6 mg/dL at 24±6 h of life.
排除标准
- •Rh incompatibility
- •Those given exchange transfusion/ phototherapy within 24 h of age.
- •Major gross congenital anomaly
- •Anticipated to require neonatal intensive care or required neonatal intensive care for more than 24 h.
- •Systemic sepsis
研究组 & 干预措施
1
study group received zinc gluconate in a dose of 10 mg/day
干预措施: zinc gluconate (Drug)
2
placebo group received placebo which was identical in color, taste and appearance and packaged in similar looking bottles.
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of hyperbilirubinemia defined as total serum bilirubin more than or equal to 15 mg/dL at anytime between days 2 and 7 of life.
时间窗: first week of life
次要结局
- The mean total serum bilirubin level at 72±12 hours of age.(first two weeks of life)
- The proportion of infants requiring phototherapy and the duration thereof(first two weeks of life)