A Study to Determine if Autologous Umbilical Cord Blood Cell Therapy Alters Serum Levels of Cytokines and Trophic Factors in Neonatal Encephalopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Changes in serum levels of cytokines and trophic factors
研究概览
简要总结
This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.
详细描述
The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study "Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618)". Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants are eligible if they meet all the following inclusion criteria except
- •≥36 weeks gestation
- •Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH <7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
- •Moderate to severe encephalopathy (Sarnat II to III)
- •A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
- •Up to 24 hours of age
- •A person with parental authority must have consented for the study.
排除标准
- •Known major congenital anomalies, such as chromosomal anomalies, heart diseases
- •Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
- •Severe growth restriction, with birth-weight less than 1800 g
- •Severe infectious disease, such as sepsis
- •Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist
结局指标
主要结局
Changes in serum levels of cytokines and trophic factors
时间窗: From birth up to 10 days of age
次要结局
- Association with neuroimaging and neurodevelopmental functional outcome(18 months)