NL-OMON55507招募中2 期
A randomised, double-blind, controlled trial to evaluate the effects of a nutritional product on brain integrity in preterm infants - NutriBrain
utricia0 个研究点目标入组 98 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •- Gestational age of 24+0 to <30+0 weeks (by the best estimate of expected
- •date of delivery)
- •- Less than 72 hours old, and the intention to receive the first administration
- •of study product between 48-72 hours after birth
- •- Written informed consent from custodial parent(s)
排除标准
- •- Any relevant proven or suspected chromosomal anomaly, metabolic disorder,
- •genetic syndrome or congenital central nervous system malformation
- •- Presence of a congenital central nervous system infection
- •- Presence of any gastrointestinal malformation
- •- No realistic prospect of survival
- •- Concomitant participation in other intervention studies (for example, but not
- •exclusively, those studies involving investigational or marketed nutritional or
- •pharmaceutical products) that could impact on the main outcome parameters
- •and/or subject safety
- •- Expected or foreseen inability of the subject and/or their families to adhere
- •to protocol instructions
- •- Admission from an extra regional hospital, unless that hospital is a study
- •- Currrent use of gastric inhibitors: H2-receptor antagonists (including
- •ranitidine) or proton pump inhibitors (including omeprazole)
研究者
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