Phase 2 Nerve Growth Factor (Cerebrolysin®) for Treatment of Neonatal Hypoxic Ischemic Encephalopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Side effects during cerebrolysin therapy (one course).
研究概览
简要总结
The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.
详细描述
Infants with perinatal history of moderate to severe Hypoxic ischemic encephalopathy HIE will receive 10 injections of cerebrolysin IM. Assessment of neurodevelopment will be done before , 3 and 6 months after therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant aged 3-6 months with perinatal history of moderate or severe HIE collected from his NICU's file. Criteria of neonatal asphyxia and encephalopathy according to the American College of Obstetricians and Gynecologist and American Academy of Pediatrics, metabolic acidosis with a cord pH of 7.0 or less or a base deficit of at least 12 mmol/L, early onset of encephalopathy, and multisystem organ dysfunction with exclusion of other possible causes for findings.
- •Criteria of neonatal asphyxia:
- •Full term neonate more than 36 weeks of gestation
- •pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
- •If, during this interval, a pH is between 7.01 and 7.15, a base deficit is between 10 and 15.9 mmol per liter, or a blood gas is not available, additional criteria are required. These includes an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute Apgar score of 5 or less or assisted ventilation initiates at birth and continues for at least 10 minutes.
- •Criteria of neonatal encephalopathy according to Sarnat and Sarnat. Presence of one or more signs in at least three of the following six categories:
- •level of consciousness.
- •spontaneous activity.
- •primitive reflexes (suck or Moro.
- •autonomic nervous system (pupils, heart rate, or respiration). The number of moderate or severe signs determined the extent of encephalopathy; if signs were equally distributed, the designation was based on the level of consciousness.
排除标准
- •Severe intrauterine growth retardation.
- •Congenital malformations.
- •Suspected inborn error of metabolism.
- •Suspected inherited neurologic disease.
- •Intracranial hemorrhage
- •Meningitis
研究组 & 干预措施
Cerebrolysin®, neuroregeneration
Injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
干预措施: Cerebrolysin® (Drug)
结局指标
主要结局
Side effects during cerebrolysin therapy (one course).
时间窗: 3 months
weekly physical , neurological examination and parents' reported fever or convulsion during cerebrolysin injection course (10 injections).
次要结局
- Neurodevelopmental follow up after 6 and 9 months of cerebrolysin injection.(9 months)
研究者
Sahar M.A. Hassanein, MD
Professor of Pediatrics, Children's Hospital, Faculty of Medicine
Ain Shams University