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临床试验/CTRI/2025/06/089511
CTRI/2025/06/089511尚未招募4 期

Effect of Zinc Oral Supplementation in Hyperbilirubinemia (ZOSH) on Serum Bilirubin Levels in Neonates Requiring Phototherapy: A Double-blind Randomized Controlled Trial

AIIMS Raipur1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年7月7日最近更新:

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

发起方
AIIMS Raipur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Chandra Prakash

AIIMS Raipur

研究点 (1)

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