NCT03192839已完成不适用
Early DHA Supplementation in Very Low Birth Weight Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Red Blood Cell polyunsaturated fatty acids (PUFA) levels
研究概览
简要总结
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Very low birth weight infants weighing less than 1500 grams
- •Consent signed within 72 hours of life
排除标准
- •Infants with know metabolic disorder
- •Infants with known congenital GI anomaly
- •Infants who are deemed to be inappropriate for enrollment per attending neonatologist
研究组 & 干预措施
Low dose PUFA
Experimental
干预措施: Low dose PUFA (Other)
High dose PUFA
Experimental
干预措施: High dose PUFA (Other)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Red Blood Cell polyunsaturated fatty acids (PUFA) levels
时间窗: 2 weeks of age
次要结局
- Red Blood Cell PUFA levels(8 weeks of age)
- Feeding tolerance(8 weeks)
- Incidence of bronchopulmonary dysplasia(8 weeks)
- Incidence of necrotizing enterocolitis(8 weeks)
研究者
研究点 (2)
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