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临床试验/NCT04433923
NCT04433923已完成不适用

Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial

Mansoura University0 个研究点开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
主要终点
Total serum bilirubin

研究概览

简要总结

prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

年龄范围
— 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines

排除标准

  • Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

结局指标

主要结局

Total serum bilirubin

时间窗: 48 hours of treatment

measurement of Total serum bilirubin (mg/dl)

次要结局

  • duration of photo therapy(average 48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abd Elazeez Attala Shabaan

Professor

Mansoura University

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