Conventional Versus LED Phototherapy and Their Effect on Lymphocytes Subsets of Full Term Neonates With Hyperbilirubinemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets
研究概览
简要总结
The aim of this study is to investigate the influence of the use of different types of phototherapy on different lymphocytes subsets CD4 and CD8 in the treatment of hyperbilirubinemia in neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term neonates with a gestational week higher than 37weeks, according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns are determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
- •Clinically significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
- •No pathologic etiological factors for hyperbilirubinemia
排除标准
- •Total bilirubin level of >20 mg/dl.
- •Prematurity.
- •Congenital anomaly.
- •Elevation in direct bilirubin level.
- •History of immune deficiency the family.
- •History of preeclampsia or any other diseases or drug use of the mother
研究组 & 干预措施
conventional phototherapy
neonates with unconjugated hyperbilirubinemia exposed to conventional phototherapy
干预措施: phototherapy (Device)
LED phototherapy
neonates with unconjugated hyperbilirubinemia exposed to LED phototherapy
干预措施: phototherapy (Device)
Control group
结局指标
主要结局
Effect of types of phototherapy on change in CD4 and CD8 lymphocytes subsets
时间窗: 2 days
Detection of CD4 and CD8 absolute counts(x10³/uL) : was done before and 48 hours after phototherapy and for controls at time of examination using monoclonal antibodies and measured by flow cytometry
次要结局
未报告次要终点
研究者
Rania Ali El-Farrash
Assistant professor
Ain Shams University