Safety and Efficacy of Autologous Umbilical Cord Blood Mononuclear Cells Transfusion in Neonates
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- number of patients who died
研究概览
简要总结
To study the safety and efficacy of Autologous Umbilical Cord Blood Mononuclear Cells transfusion on clinical outcome in preterm infants
详细描述
This is a Phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of Autologous Umbilical Cord Blood Mononuclear Cells --25 million cells/kg, 48 hours after birth. And the placebo will be 0.9% sodium chloride.The investigator will proceed the groups during the same period.
- Demographic Data and Baseline Characteristics of the Studied Groups were collected:
- Gestational age (weeks)
- Birth weight (g)
- gender
- Cesarean section delivery
- Antenatal steroids
- Prolonged rupture of membrane
- Multiple pregnancies
- APGAR score at 5 minutes
- Thrombocytopenia before intervention
- CRP before intervention (mg/L)
- TNF-α(tumor necrosis factor α ) before intervention (pg/mL)
- Assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously
- Autologous cord blood mononuclear cells doses is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，and with same volume of 0.9% sodium chloride as placebo.
- The following are monitored at 3、7、14、21 days after birth:
- mortality, incidence of sepsis, neonatal respiratory distress syndrome (NRDS), bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotising enterocolitis (NEC), intraventricular haemorrhage (IVH), Hypoxic Ischemic Encephalopathy (HIE), anaemia, thrombocytopenia, neutrophil,TBNK cells subgroup, before hospital discharge.
- Long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment [Bayley Scales of Infant], asthma, anemia and physique growth.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Twenty-eight weeks to thirty-seven weeks
排除标准
- •Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
研究组 & 干预措施
Placebo1
0.9% sodium chloride infusion 48 hours after birth ,the infusion speed is 4ml/kg/h， 8-12h，
干预措施: 0.9% Sodium Chloride (Drug)
CBMNC
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 48 hours after birth ,dose is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，
干预措施: Autologous Umbilical Cord Blood Mononuclear Cells Therapy (Other)
结局指标
主要结局
number of patients who died
时间窗: up tp 21 days after birth
mortality rate
次要结局
- number of patients with neurodevelopmental disorder assessed by Bayley Score(up to 1 month, 3 months, 6 months and 1 year)
研究者
yangjie
Professor
Guangdong Women and Children Hospital