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临床试验/NCT03192839
NCT03192839已完成不适用

Early DHA Supplementation in Very Low Birth Weight Infants

Mead Johnson Nutrition4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
4
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

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

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

  • Feeding tolerance(8 weeks)
  • Incidence of bronchopulmonary dysplasia(8 weeks)
  • Incidence of necrotizing enterocolitis(8 weeks)
  • Red Blood Cell PUFA levels(8 weeks of age)

研究者

发起方
Mead Johnson Nutrition
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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