DRKS00006541已完成3 期
A prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral vitamin A supplementation of 5000 IU/kg/d versus placebo for 28 days for preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants. - NeoVitaA
niversität des Saarlandes, Saarbrücken, Deutschland0 个研究点目标入组 914 人开始时间: 2014年9月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 914
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 22 Pregnancy 至 32 Pregnancy（—）
- 性别
- All
入选标准
- •Neonates with a birth weight <1000 g
- •- Neonates with a gestational age < 32 + 0 weeks at time of inclusion into the trial
- •- Who receive any oxygen supplementation or respiratory support after Admission to the NICU within 72 hours following birth
- •- Who (will) receive a basic VA supplementation of 1000 IU/kg body weight/day
- •(7000 IU/kg body weight/week)
- •- Postnatal age <72 hours of life
- •- Minimal/enteral feeds commenced
- •- Signed and dated informed parental consent
排除标准
- •- =1 major congenital abnormalities
- •- Congenital nonbacterial infection with overt signs at birth
- •- Terminal illness as evidenced by pH <7.0 for >2 hours or persistent bradycardia (heart rate <100 bpm) associated with hypoxia for >2 hours
- •- Birth weight <400 g
- •- Participation in another clinical trial according to German Drug Law (AMG)
研究者
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