Parenteral Nutrition Light Protection and Premature Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serum levels of direct bilirubin
研究概览
简要总结
Investigators propose a prospective study to investigate the effect of full light protection of the PN on cholestasis and other oxidative stress associated diseases in premature infants when they receive PN for more than one week. Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing. Demographic characteristics, clinical outcomes (incidence of cholestasis, feeding tolerance, BPD, ROP, NEC and mortality) and oxidative stress markers (e.g., carboxyhemeglobin) will be evaluated. Phase one of this study employed a retrospective chart review methodology to evaluate the effect of no PN light protection vs partial PN light protection (PN solution only while it's the tubing and lipids remained exposed to light). Infants from phase one of this study will serve as the controls in the evaluation the effect of full PN light protection on the cholestasis, clinical outcomes and oxidative stress. Investigators propose to collect urine and saliva samples in infants who we expect to receive PN for a minimum of 5 days, on days 0, 3, 5 and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition to evaluate oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 32 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Serum levels of direct bilirubin
时间窗: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of liver enzymes
时间窗: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of triglycerides
时间窗: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of carnitine
时间窗: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
Serum levels of total bilirubin
时间窗: Baseline, 2 weeks after the end of IV nutrition
Change from baseline
次要结局
- Mortality(Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition)
- Oxidative stress(Baseline, 2 weeks after the end of IV nutrition)
- Incidence of bronchopulmonary disease (BPD)(Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition)
- Incidence of retinopathy of prematurity (ROP)(Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition)
- Incidence of necrotizing enterocolitis (NEC)(Days 0, 3, 5, and every 7 days after TPN initiation until 2 weeks after the end of IV nutrition)
