Melatonin for Neuroprotection Following Perinatal Asphyxia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Serum melatonin concentration (pg/ ml)
研究概览
简要总结
The aim of this study is to examine the effect of combining melatonin to whole body cooling on the brain injury and outcome of neonates following perinatal asphyxia.
详细描述
This is a prospective study on 30 neonates with moderate to moderately to severe hypoxic ischemic encephalopathy (HIE) . HIE infants are randomized into two groups: Whole body cooling group (N = 15; receive 72 hours of whole body hypothermia) and melatonin/ hypothermia group (N = 15; receive hypothermia and 5 daily enteral doses of melatonin 10 mg/kg). Serum melatonin, plasma superoxide dismutase (SOD),and serum nitric oxide (NO) are measured at enrollment and after 2 weeks for the two HIE groups. The HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks. Brain MRI was performed after 2 weeks of life. Neurologic evaluations and Denver Developmental Screening Test II assessments were performed at 6 months. A group of healthy newborns will be used as a control for baseline labs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inborn infants at term gestation (38-42 weeks)
- •Apgar scores ≤ 3 at 5 minutes and/or delayed first breath (>5 minutes after birth)
- •Profound metabolic or mixed acidosis with serum bicarbonate levels of <12 mmol/L in initial blood gas analyses
- •Evidence of moderate or moderate to severe encephalopathy, such as lethargy, seizures, abnormal reflexes, or hypotonia, in the immediate neonatal period
排除标准
- •Twin gestation
- •Maternal neuro-endocrinal disturbances including diabetes mellitus
- •Chorioamnionitis or congenital infections
- •Low birth weight less than 2.5 kg
- •Congenital malformations of the central nervous system or gastrointestinal anomalies
- •Chromosomal abnormalities
- •After 6 hours of birth.
- •Patients in extremis such as: (1) hypoxemia requiring supplemental oxygen 100% FiO2, (2) life threatening coagulopathy, or (3) deep coma.
研究组 & 干预措施
Melatonin/ hypothermia group
HIE infants who will receive melatonin in addition to the routine cooling protocol
干预措施: Melatonin (Drug)
结局指标
主要结局
Serum melatonin concentration (pg/ ml)
时间窗: 5 days
Plasma superoxide dismutase (SOD) activity (U/ml)
时间窗: 5 days
Serum nitric oxide (NO) concentrations (µmol/L)
时间窗: 5 days
次要结局
- Incidence of EEG abnormalities(2 weeks)
- Incidence of MRI abnormalities(2 weeks)
- Incidence of abnormal neurological examination(6 months)
- Incidence of abnormal Denver Developmental Screening Test II(6 months)
研究者
Heba Mahdy
Assistant Professor of Pediatrics
Tanta University