Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Oxidant-antioxidant state
研究概览
简要总结
Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions.
详细描述
This study will be a prospective single blinded randomized control trial.
Inborn preterm infant less than 32 wks gestational age, receiving TPN in neonatal intensive care unit (NICU) of Mansoura University Children's Hospital as a part of their care will be included.
Preterm infant will be randomly divided into 2group:- Group 1 includes preterm infant who will receive their TPN through bags and tubing system that are protected from light by aluminum foil.
Group 2 includes preterm infant who will receive their TPN through bags and tubing system that are exposed to light.
Randomization will be done using random table technique with opaque sealed envelopes containing the serial number and the group to which the subject will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Hours 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant less than 32 weeks gestational age
排除标准
- •Infant with major congenital anomalies
- •Infant of diabetic or hypertensive mother
研究组 & 干预措施
Light-protection
Light-protection of TPN solutions. TPN bags and infusion sets will be protected from light by aluminum foils throughout the study period.
干预措施: Light-protection of TPN solutions (Other)
Light-exposure
TPN bags and infusion sets will be exposed to light throughout the study period.
干预措施: Light-protection of TPN solutions (Other)
结局指标
主要结局
Oxidant-antioxidant state
时间窗: 7 days
Measurement of urinary peroxides and serum GSH/GSSG ratio
次要结局
- Sepsis(60 dyas)
- Length of hospital stay(60 days)
- Metabolic disturbance(60 days)
- Time to full feeding(30 days)
- Death and/or Bronchopulmonary dysplasia(60 days)
- Necrotizing enterocolitis as Bell's stage 2 or more(60 days)
- Retinopathy of prematurity pre-threshold and threshold stages(60 dyas)
- Duration of respiratory support(60 days)
- Neonatal cholestasis(60 days)
研究者
Nehad Nasef
Assistant professor, PhD
Mansoura University Children Hospital