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临床试验/NCT06173856
NCT06173856已完成不适用

Effectiveness of Phototherapy With and Without Probiotics for the Treatment of Indirect Hyperbilirubinemia in Preterm Neonates

Fatima Jinnah Medical University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
2
主要终点
effectiveness

研究概览

简要总结

Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the duration of phototherapy and hospitalization stay, secondarily can reduce the risk of nosocomial infection.

详细描述

Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The comparative analytical study was conducted after the ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection criteria were included in the study and divided into two groups.

Standard phototherapy was applied in both groups and group A probiotic (Saccharomyces boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was given till discharge from the hospital. The primary outcome measurements were the duration of phototherapy and the length of hospitalization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Hours 至 1 Week(Child)
性别
All
接受健康志愿者

入选标准

  • All the Neonates with indirect hyperbilirubinemia,
  • Born at ;37 weeks of gestation
  • Both male and female neonates were included in the study

排除标准

  • Neonates with sepsis,
  • bilirubin level in exchange transfusion range
  • direct hyperbilirubinemia
  • Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick

结局指标

主要结局

effectiveness

时间窗: 1 to 2 weeks

mean duration of phototherapy and the mean duration of hospital stay with and without probiotics for treatment of indirect hyerbilirubinemia in preterm neonates probiotics for the treatment of indirect hyperbilirubinemia in preterm neonates

次要结局

未报告次要终点

研究者

发起方
Fatima Jinnah Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Naeem Afzal

Professor

Fatima Jinnah Medical University

研究点 (2)

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