A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic (HIE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85
研究概览
简要总结
This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
详细描述
The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Hours 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
- •Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
- •The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
- •All infants must have signs of encephalopathy within 6 hours of age
排除标准
- •Major congenital or chromosomal abnormalities
- •Severe growth restriction (birth weight <1800 g)
- •Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
- •Moribund neonates for whom no further treatment is planned
- •Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
- •Infants suspected of overwhelming sepsis
- •ECMO initiated or likely in the first 48 hours of life
结局指标
主要结局
Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85
时间窗: 1 year
The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15.
Survival at One Year
时间窗: 1 year
Number of participants alive at one year.
次要结局
- Number of Subjects Who Are Discharged on Anti-epileptic Medication(At hospital discharge, approximately 4-92 days)
- Mortality Rate(1 year)
- Number of Subjects Who Require ECMO(During hospitalization, approximately 4-92 days)
- Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding(During hospitalization, approximately 4-92 days)
- Number of Subjects Who Experience Seizures(During hospitalization, approximately 4-92 days)
- Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use(During hospitalization, approximately 4-92 days)
研究者
Michael Cotten
Associate Professor
Duke University