Effect of Oral Zinc Supplimentation On Serum Bilirubin Levels In Neonates With Hyperbilirubinemia Undergoing Phototherapy : A Open Labeled, Randomised Controlled Trail.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the effect of oral zinc on serum bilirubin levels in neonates with hyperbilirubinemia undergoing at phototherapy
研究概览
简要总结
Dr. Supreeth SV from Sri Devaraj Urs Medical College aims to study the impact of oral zinc supplementation on serum bilirubin levels in neonates with hyperbilirubinemia undergoing phototherapy. Neonatal jaundice, caused by bilirubin accumulation, can lead to serious neurological complications if untreated. Zinc may reduce bilirubin levels by blocking its production. Previous studies suggest zinc’s efficacy in reducing phototherapy duration. This open-label randomized controlled trial will include late preterm to post-term neonates. Data will be collected from RL Jalappa Hospital over 18 months. Ethical clearance has been obtined, with CTRI registration in progress. Statistical analysis will utilize SPSS software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 10.00 Day(s)（—）
- 性别
- All
入选标准
- •All late preterm(≥35weeks), term, post term neonates admitted with hyperbilirubinemia in phototherapy range.
排除标准
- •Neonates with direct hyperbilirubinemia • Major gross congenital anomalies (gastrointerstinal malformations, heart defects, neural tube defects) and with identifiable genetic syndromes.
- •â€¢ Preterm neonate(≥35weeks), who are already started on zinc supplementation.
结局指标
主要结局
To evaluate the effect of oral zinc on serum bilirubin levels in neonates with hyperbilirubinemia undergoing at phototherapy
时间窗: To evaluate the effect of oral zinc on serum bilirubin levels in neonates with hyperbilirubinemia undergoing at 5 daysphototherapy | To correlate the effect of oral zinc and duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy
To correlate the effect of oral zinc and duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy at baseline
时间窗: To evaluate the effect of oral zinc on serum bilirubin levels in neonates with hyperbilirubinemia undergoing at 5 daysphototherapy | To correlate the effect of oral zinc and duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy
次要结局
- To correlate the effect of oral zinc & duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy at 5 days(To correlate the effect of oral zinc & duration of phototherapy in neonates with hyperbilirubinemia undergoing phototherapy at 5 days)
研究者
Dr Supreeth sv
Sri Devaraj urs medical college