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临床试验/CTRI/2023/03/050811
CTRI/2023/03/050811已完成4 期

Effect of single dose Fenofibrate as an adjunct to Phototherapy Vs Phototherapy alone in Unconjugated Neonatal Hyperbilirubinemia-A Randomnised Control Trial.Monitor the ADR carefully and if any ADR happens treat them free of cost.

Deepaa S0 个研究点目标入组 94 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
94

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Unconjugated hyperbilirubinemia who needed phototherapy according to American Academy of Paediatric (AAP) criteria (phototherapy graph),
  • 2.Term baby (with gestational age of >37 weeks to 42 weeks),
  • 3.Exclusively breastfed,
  • 4.Total serum bilirubin(TSB) levels above 15.0 to 21.0mg/dl,
  • 5.Age >24 hours to 14 days,
  • 6.Birth weight 2500 to 3999 grams.

排除标准

  • 1.Neonate with conjugated hyperbilirubinemia >2 mg/dl or >15% of TSB,
  • 2.Hemolytic jaundice due to Rh or ABO incompatibility
  • 3.Birth weight <2500 grams and gestational age <37 weeks,
  • 4.G6PD deficiency or Hypothyroidism,
  • 5.Congenital anomalies and structural anomalies of liver and kidney,
  • 6.Very sick neonates with jaundice (suspected infections, dehydration, asphyxia, inborn errors of metabolism, coagulation disorders)

研究者

发起方
Deepaa S

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