NCT02999373已完成2 期
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Guangdong Women and Children Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
研究概览
简要总结
Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD).
This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.
排除标准
- 未提供
结局指标
主要结局
bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
时间窗: 36 weeks of postmenstrual age or the discharge
bronchopulmonary dysplasia rate
次要结局
- number of patients with severe BPD in survivors(36 weeks of postmenstrual age or the discharge)
- number of patients died before discharge from hospital(before discharge from hospital)
- the duration of mechanical ventilation(before discharge from hospital)
研究者
yang jie
Professor
Guangdong Women and Children Hospital
研究点 (1)
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