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临床试验/NCT00328419
NCT00328419已完成不适用

Consequences of Parenteral Nutrition Photoprotection on the Oxidant Related Diseases Among Extremely Low Birth Weight Infants : A Randomized Controlled Study

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 591 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
591
试验地点
2
主要终点
Death or bronchopulmonary dysplasia at 28 days

研究概览

简要总结

The antioxidant system of very low birth weight infants is immature. This immaturity is implicated in the pathogenesis of diseases such as bronchopulmonary dysplasia or retinopathy. The main source of oxidant is oxygen, and parenteral nutrition is contaminated with oxidant. Photoprotection decreases the oxidant load infused with parenteral nutrition. In a preliminary study, photoprotection reduced the frequency of pulmonary bronchodysplasia, increased the quantity of enteral nutrition tolerated, and decreased the arterial blood pressure among very low birth weight infants. The aim of this study is to evaluate the impact of photoprotection on oxidant related diseases among very low birth weight infants. This study is a randomized multicenter trial. In the intervention group, photoprotection is applied until the infusion of parenteral nutrition with amber bags, tubing, and syringes. The quality of photoprotection is controlled by measuring malondialdehyde and cysteine after 24 hours of infusion. The control group will receive parenteral nutrition with transparent bags and tubing. The outcomes are evaluated at 36 weeks, and 680 infants will be enrolled, with stratification among centers and gestational age.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Day 至 6 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born before 30 weeks gestational age
  • Postnatal age between 1 and 6 days
  • Apgar score up to 2

排除标准

  • Severe congenital abnormalities
  • Intraventricular hemorrhage grade up to 2
  • Proven sepsis before inclusion
  • Transfusion before inclusion
  • Use of intravenous lipids or parenteral nutrition before randomisation

结局指标

主要结局

Death or bronchopulmonary dysplasia at 28 days

时间窗: 28 days

次要结局

  • sepsis(28 days and 36 weeks)
  • intraventricular hemorrhage(7 days, 24days, 36 weeks)
  • Retinopathy of prematurity(36 weeks)
  • tolerance of enteral nutrition(during enteral nutrition)
  • enterocolitis(36 weeks)
  • periventricular leucomalacia(36 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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