NCT01955044已完成不适用
Early DHA Supplementation in Extremely Low Birth Weight Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
研究概览
简要总结
The purpose of this study is to determine if buccal administration of a concentrated formulation of long-chain polyunsaturated fatty acids (LCPUFA) can help to maintain docosahexaenoic acid (DHA) levels in extremely low birth weight (ELBW) infants.
详细描述
This will be a multi-center, randomized, placebo controlled, double blind trial.
Two doses of PUFA will be compared to placebo- a "high" dose and a "low" dose.
ELBW infants will be enrolled into this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a) Premature infant born at gestational age less than 34 weeks
- •b) Birth weight less than 1000 grams
- •c) Legally authorized representative is able to provide written informed consent within the first 72 hours of life, prior to the performance of an protocol-specified evaluations or procedures
排除标准
- •a) infants with known metabolic disorder
- •b) infants with known congenital gastrointestinal anomaly
- •c) infants who are deemed to be inappropriate for enrollment per attending neonatologist
结局指标
主要结局
Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels
时间窗: 2 weeks of life
LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants
次要结局
- LCPUFA Levels(8 weeks of life)
研究者
Brandy Frost
Attending Neonatologist, Clinician Educator
Endeavor Health
研究点 (6)
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