Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The occurrence of Necrotizing enterocolitis in hospitalization
研究概览
简要总结
Pre-clinical animal studies provide robust evidence regarding the beneficial effect of stem cells for intestinal disease.
This single-center, randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing NEC in preterm neonates,and influence on growth and development.
详细描述
Study design and settings:
This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 45 singleton preterm infants (GS<33 weeks) of fulfilling the eligibility criteria will be enrolled. According to the infusion of umbilical cord blood mononuclear cells and equal dose placebo, the premature infants were divided into infusion group and control group. The two groups were matched with gender, gestational age and birth weight as stratified variables and 1:2 (the gender was the same, and the difference between gestational age and birth weight was the smallest).
Trial treatment methods: Study design and settings:
This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. Subsequently, one baby of each twin will be randomly divided into the ACBMNC infusion group or control (placebo) group.
Trial treatment methods:
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
- None
盲法说明
Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 26 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) 26<GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes;
- •Exclusion criteria： (1) mothers with clinical chorioamnionitis; (2) the mother was opsitive 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; (3) consent was not obtained from the parents or guardians; and (4) after processing, UCB cells were not available.
排除标准
- 未提供
研究组 & 干预措施
Autologous cord blood mononuclear cells
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
干预措施: Autologous Umbilical Cord Blood Mononuclear Cells Therapy (Other)
Placebo
0.9% sodium chloride infusion 24 hours after birth
干预措施: 0.9% Sodium Chloride (Drug)
结局指标
主要结局
The occurrence of Necrotizing enterocolitis in hospitalization
时间窗: up to one year
NEC rate
次要结局
- The severity of Necrotizing enterocolitis(up to one year)
- The occurrence of feeding intolerance(up to one year)
- The occurrence of other intestinal disease(up to one year)
研究者
yang jie
Professor
Guangdong Women and Children Hospital