Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial
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
- 否
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
研究组 & 干预措施
GROUP2
Phototherapy without aluminum foil
干预措施: Phototherapy without aluminum foil (Device)
GROUP1
Phototherapy with aluminum foil
干预措施: Phototherapy with aluminum foil (Device)
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)
Total serum bilirubin
时间窗: 8 hours of treatment
measurement of Total serum bilirubin (mg/dl)
Total serum bilirubin
时间窗: 24 hours of treatment
measurement of Total serum bilirubin (mg/dl)
次要结局
- duration of photo therapy(average 48 hours)
研究者
Abd Elazeez Attala Shabaan
Professor
Mansoura University