NCT00611546已完成不适用
Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Concentration of peroxides in the urine
研究概览
简要总结
In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined different strategies such as photo-protection, adding multivitamins to the lipid emulsion rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione to the TPN solution. However, the role of trace elements as antioxidants, and their interaction with light have not been studied. Also, the impact of TPN-related oxidants on clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm infants to evaluate the role of different components of TPN on urinary peroxides and to examine the biochemical and clinical effects of light protection.
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
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants included are:
- •with gestational age between 28 to 34 weeks
- •managed with TPN as part of their care in the NICU
- •their postnatal age on enrolment was < 7 days
排除标准
- •Infants are excluded if they have:
- •Clinical evidence of sepsis, or a positive blood culture on admission
- •Hepatobiliary dysfunction
- •Persistent metabolic acidosis with base deficit > 10 mEq / L
- •Renal impairment (urine output < 1 ml/kg/hour and serum creatinine > 1 mg/dl)
- •Disseminated intravascular coagulopathy
- •Maternal conditions known to be associated with oxidative stress such as preeclampsia, hypertension and diabetes.
结局指标
主要结局
Concentration of peroxides in the urine
时间窗: 48 hours
次要结局
- Clinical morbidities (death, and bronchopulmonary dysplasia)(during hospital stay)
研究者
相似试验
已完成
不适用
Pilot study: Role of anti-oxidants in the elicitation of contact allergic reaction to p-phenylenediamine (PPD).Contact dermatitisNL-OMON40582niversitair Medisch Centrum Groningen22
撤回
不适用
Skin Hydration in Persons With Acne After Dietary Supplementation With Botanical AntioxidantsAcne VulgarisAcneNCT04534140University of California, Los Angeles
已完成
不适用
An investigation study of antioxidant effect and improving blood circulation: A randomized double-blind placebo-controlled trialJPRN-UMIN000035083ORTHOMEDICO Inc.33
已完成
2 期
Combined Antioxidant Therapy on Oxidative Stress in Aqueous and Vitreous Humor of Diabetic Retinopathy PatientsOxidative StressDiabetesDiabetic RetinopathyNCT04071977University of Guadalajara40
已完成
不适用
Influence of antioxidant supplementation during exercise in the heatISRCTN70807761niversity of Bath (UK)12