ISRCTN96620855进行中（未招募）未知
A randomised, double-blind, controlled trial to evaluate the effects of a nutritional product on brain integrity in preterm infants
utricia Research0 个研究点目标入组 88 人开始时间: 2017年10月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
研究概览
简要总结
2021 protocol in https://pubmed.ncbi.nlm.nih.gov/33731062/ (added 21/04/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 21/04/2021:
- •1. Gestational age of 24+0 to <30+0 weeks (by the best estimate of expected date of delivery)
- •2. Less than 72 h old, and the intention to receive the first administration of study product between 48-72 h after birth
- •3. Written informed consent from custodial parent(s)
- •Previous inclusion criteria:
- •1. Gestational age of 24+0 to <30+0 weeks (by the best estimate of expected date of delivery)
- •2. Less than 72 hours old, and the possibility to receive the first administration of study product between 48-72 hours after birth
- •3. Written informed consent from custodial parent(s)
排除标准
- •Current exclusion criteria as of 21/04/2021:
- •1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation
- •2. Presence of a congenital central nervous system infection
- •3. Presence of any gastrointestinal malformation
- •4. No realistic prospect of survival
- •5. 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
- •6. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions
- •7. Admission from an extra regional hospital, unless that hospital is a study site
- •8. Current use of gastric acid inhibitors: H2-receptor antagonists (including ranitidine) or proton pump inhibitors (including omeprazole)
- •Previous exclusion criteria:
- •1. Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation
- •2. Presence of a congenital central nervous system infection
- •3. Presence of any gastrointestinal malformation
- •4. No realistic prospect of survival
- •5. 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
- •6. Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions
- •7. Admission from an extra regional hospital, unless that hospital is a study site
- •8. Current use of anti-reflux medication
研究者
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