Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Anemia: Change from Baseline Hematocrit
研究概览
简要总结
The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group.
Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •evidence of asphyxiation, defined by 5-minute Apgar score ≤ 5;
- •evidence of HIE, defined by UCB pH <7.15 or base excess ≤ 10mM;
- •subjects with HIE confirmed by clinical features and initial investigations;
- •subjects with evidence of anemia, defined by hematocrit < 40% or hemoglobin ≤ 13g/dL within the first 96 hours of life;
- •obtain the informed consent from parents
排除标准
- •congestive cardiac failure;
- •microcephaly, anencephaly, encephalocele, or other abnormality
- •conjoint twins;
- •chromosomal disorders
- •fetal alcohol syndrome
- •spinal bifida or other neural tube defects
- •subjects have other neurological deficit conditions
- •polycythemia
- •congenital hematological malignancy
- •investigator decision
研究组 & 干预措施
Study Group
autologous UCB transfusion
干预措施: autologous umbilical cord blood (UCB) (Biological)
Control Group
standard care
干预措施: standard care (Procedure)
结局指标
主要结局
Anemia: Change from Baseline Hematocrit
时间窗: 48 hours, 1 week, 3 months, 6 months
Change from Baseline Hematocrit of the Anemia Subjects
HIE: Mortality
时间窗: 6 months
Mortality Rate of the HIE Subjects
次要结局
- Anemia: Oxygenation level(48 hours, 1 week)
- Anemia: Oxidative Stress Level(48 hours, 1 week, 3 months, and 6 months)
- HIE: HINE(6 months, 1 year and 2 years)
- HIE: HNNE(-1 day, 3 months (before discharge))
- HIE: Q-CHAT(2 years)
- HIE: GMDS(6 months, 1 year and 2 years)
- Anemia: Requirements of Packed Cell Transfusion(6 months)
- HIE: CBCL(2 years)
- Anemia: hemoglobin(48 hours, 1 week, 3 months and 6 months)