NCT03978000进行中（未招募）3 期
A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study
Infant Bacterial Therapeutics89 个研究点 分布在 1 个国家目标入组 2,158 人开始时间: 2019年7月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,158
- 试验地点
- 89
- 主要终点
- Confirmed necrotizing enterocolitis (NEC)
研究概览
简要总结
IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.
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 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
- •Birth weight 500-1500g
- •≤ 48 hours of age
- •Written informed consent from the subject´s legally authorized representative (LAR)
排除标准
- •Participation in any other interventional clinical trial
- •Infants in extremis to whom no further intensive care is offered by attending neonatologist
- •Infants with, or at a high probability for, early onset sepsis
- •Infants with recognized chromosomal anomalies
- •Congenital or acquired gastrointestinal disease
- •Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
- •Infants with known positive maternal HIV status
研究组 & 干预措施
IBP-9414
Active Comparator
干预措施: IBP-9414 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Confirmed necrotizing enterocolitis (NEC)
时间窗: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Time to sustained feeding tolerance
时间窗: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
次要结局
- Surgery (or autopsy) with confirmation of NEC(From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age)
- Number of days of hospitalization(From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age)
- At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication.(From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age)
- Death all causes(From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age)
- Days with clinical signs of feeding intolerance(From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age)
- Weight gain in g/kg(Weeks 3 and 4 of age)
- Number of subjects growing at ≥100 g/kg/week(Weeks 3 and 4 of age)
研究者
研究点 (89)
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