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临床试验/NCT04525872
NCT04525872已完成不适用

Parenteral Nutrition Light Protection and Premature Outcomes

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年7月10日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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