Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of other free radical diseases
研究概览
简要总结
SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Hours 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates with gestational age < 29 weeks and / or birth weight < 1000 g
- •Admission in the Intensive Care Unit within 6 h after birth
- •IV Lipid Emulsion (LE) started latest at first day of life
- •Anticipated duration of Parenteral Nutrition >10 days
- •Informed consent from legal representative
排除标准
- •Inherited metabolic diseases
- •Major congenital malformations
- •Participation to another study evaluating any kind of medications
结局指标
主要结局
Rate of other free radical diseases
时间窗: 36 weeks corrected age
Free radical diseases include: intraventricular hemorrhage (IVH) \> grade II, retinopathy of prematurity (ROP) \> grade II, and necrotizing enterocolitis (NEC) \> grade IA (Bell classification).
次要结局
- Weight gain(week 36 corrected age)
- Growth velocity(week 36 corrected age)
- Head circumference growth velocity(at week 36 corrected age)