Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Effect of types of phototherapy on change in malonaldehyde (MDA)
研究概览
简要总结
The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.
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
- 2 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were 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.
- •Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
- •Normal blood counts and peripheral blood smears
- •Normal reticulocytic count.
- •Breast fed newborn.
排除标准
- •Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
- •Infant of diabetic mothers.
- •Maternal eclampsia-preeclampsia.
- •Birth asphyxia
- •congenital anomalies.
- •Direct Coombs'test positive
- •Pathological causes of hyperbilirubinemia.
- •Enclosed hemorrhage.
- •Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.
结局指标
主要结局
Effect of types of phototherapy on change in malonaldehyde (MDA)
时间窗: 2 days
This will be determined by: 1. Measure MDA (nmol/L) before and after phototherapy 2. Compare results of MDA (nmol/L) before and after phototherapy.
Effect of types of phototherapy on change in total antioxidant capacity (TAC)
时间窗: 2 days
This will be determined by: 1. Measure TAC (mmol/L) before and after phototherapy 2. Compare results of TAC (mmol/L) before and after phototherapy.
Effect of types of phototherapy on change in nitric oxide (NO)
时间窗: 2 days
This will be determined by: 1. Measure NO (umol/L) before and after phototherapy 2. Compare results of NO (umol/L) before and after phototherapy.
次要结局
- Effect of types of phototherapy on change in serum iron (Fe)(2 days)
- Effect of types of phototherapy on change in serum calcium (Zn)(2 days)
- Effect of types of phototherapy on change in serum zinc (Zn)(2 days)
- Effect of types of phototherapy on change in serum copper (Cu)(2 days)
研究者
Rania Ali El-Farrash
Assistant professor
Ain Shams University