Autologous Cord Blood Cells for Prevention of BPD in Preterm
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
- number of patients without bronchopulmonary dysplasia
研究概览
简要总结
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
详细描述
We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born in the study hospital;
- •singleton birth;
- •less than 32 weeks GA
- •Without congenital malformations or known chromosomal aberrations;
- •Without clinical chorioamnionitis;
- •the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus;
- •consents were obtained from their parents or guardians;
- •the umbilical cord blood cells after processing were available.
排除标准
- •birth-weight was less than the third percentile for gestational age according to Fenton curve,
- •if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.
研究组 & 干预措施
Placebo
0.9% sodium chloride infusion within 24 hours after birth
干预措施: 0.9% Sodiun Chloride (Drug)
ACBMNC
Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg ,
干预措施: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy (Other)
结局指标
主要结局
number of patients without bronchopulmonary dysplasia
时间窗: at 36 weeks of postmenstrual age or discharge home, whichever came first
bronchopulmonary dysplasia incidence
次要结局
- number of patients who died， severe bronchopulmonary dysplasia(at 36 weeks of postmenstrual age)
研究者
yangjie
Director of Dept of Neonatology
Guangdong Women and Children Hospital