The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 320
- 主要终点
- number of patients who died
研究概览
简要总结
Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems
详细描述
This is a Phase 1 clinical trial that constitues one time points cohor and three group,each group with 80 participants,which receive intratracheal PS and mononuclaer cells,receive intratracheal PS,receive intratracheal mononuclaer cells.
- Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks)
- Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
- Demographic Data and Baseline characteristics of the study 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 befor intervention(mg/l) TNF-αbefore intervention（pg/ml） 4.Autologous cord blood mononuclear cells doses is 25million cells/kg 5.the following are monitored at 3、7、14、21 days after birth: mortality, incidence of bronchopulmonary dysplasia 5.Long-term follow up:in 1m，3m，6m,1y:neurodevelopment,asthma，anemia and physic 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 36 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
- •Pretem 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
infusion froup 1
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
干预措施: CBMNC (Biological)
infusion group 2
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
干预措施: PS+CBMNC (Biological)
Placebol
0.9% sodium chloride installation after 24 hours
干预措施: Placeo (Other)
infusion group 3
PS,dose is 70mg/kg
干预措施: PS (Biological)
结局指标
主要结局
number of patients who died
时间窗: up to 21 days after birth
mority rate
次要结局
- number of patients with neurodevelopmental disorder assessed by Bayley Score(up to 1 month, 3 month, 6 months and 1 year)
研究者
yangjie
Director of Dept of Neonatology
Guangdong Women and Children Hospital