Effect of Zinc Oral Supplementation in Hyperbilirubinemia (ZOSH) on Serum Bilirubin Levels in Neonates Requiring Phototherapy: A Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Sequential levels of serum bilirubin during hospital stay at 24 hours and at time of discharge
研究概览
简要总结
Neonatal hyperbilirubinemia is one of the common causes of neonatal morbidity. It manifests with the rise of unconjugated bilirubin levels in the neonatal blood, which results in yellowish staining of the skin and sclera. The major contributing factors are the breakdown of RBCs, immaturity of neonates’ liver, lack of intestinal flora, and enhanced enterohepatic circulation (EHC). EHC contributes significantly to neonatal hyperbilirubinemia, and its blockage might be a therapeutic target for this condition. Zinc due to its bilirubin adsorbing properties has been studied in animal models to reduce EHC and serum zinc level in neonates is reported to be one of the factors affecting the severity and incidence of neonatal hyperbilirubinemia. Studies have shown that the use of zinc syrup in preterm infants with indirect hyperbilirubinemia significantly reduced bilirubin levels within 48 hours of treatment. However there are sporadic studies on the effect of zinc on the reduction of hyperbilirubinemia in pre-term neonates and much less in term neonates, therefore there is a need to research further the effects of zinc on hyperbilirubinemia in pre-term and term babies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)(—)
- 性别
- All
入选标准
- •All pre-term and term neonates admitted to NICU with hyperbilirubinemia for phototherapy.
排除标准
- •Neonates with direct hyperbilirubinemia
- •Neonates with other systemic illnesses, severe sepsis, severe respiratory disease requiring mechanical ventilation, oral intolerance, and major gross congenital anomalies .
- •Neonates whose parents refuse to give consent.
- •neonates requiring exchange transfusion at admission for hyperbilirubinemia.
结局指标
主要结局
Sequential levels of serum bilirubin during hospital stay at 24 hours and at time of discharge
时间窗: 24 hours post start of phototherapy
次要结局
- 1. Duration of phototherapy (in hours)(2. Duration of hospital stay)
研究者
Chandra Prakash
AIIMS Raipur
