Verification of Biomarkers to Examine Neonatal Asphyxia Induced Hypoxic-ischemic Encephalopathy. A Prospective Multicenter Observational Study for Development of a Diagnostic Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 4
- 主要终点
- abnormal short-term outcome (NE)
研究概览
简要总结
Verification of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies.
详细描述
The aim of the study is to verify the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk.
The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Hours 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: inclusion criteria fulfilled for hypothermia treatment Group 2: Infants with suspected perinatal brain injury due to one of the followings
- •Perinatal hypoxia-ischemia (defined as a perinatal acidosis indicated by a pH≤7.10 or a base excess ≤-12mmol/l in umbilical cord blood or early postnatal blood collected at <90min of age (outborn patients)
- •5min APGAR-score ≤ 5
- •Need for resuscitation after birth for >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube, or cardiac compressions Group 3: UApH >7,25, and adaptation disorder of the newborn and need of postnatal clinical surveillance
排除标准
- •gestational age < 36 weeks
- •age at time of screening >2,5h
- •congenital malformation
- •missing or invalid informed parental consent
- •unsuccessful resuscitation
- •infant considered not-viable
- •decision for palliative care only
结局指标
主要结局
abnormal short-term outcome (NE)
时间窗: 14 days for clinical diagnosis
All patients are classified as abnormal short-term outcome (neonatal encephalopathy, NE) or normal short term outcome (no encephalopathy) by using clinical data, particularly Thompson score. For Group 1 and group 2 patients outcome classification will be additionally confirmed by using cranial ultrasound or MRI (including severe ischemia based on DWI or thalamic or cerebellar bleeding or arterial infarction or IVH\>2° according to Papile, thalamic ischemia or severe cerebral edema) or seizure activity or burst suppression on aEEG or persistingly abnormal aEEG background pattern after complete rewarming. Bloodplasma samples will be analysed by a metabolomics approach using the p180-kit (Biocrates, Innsbruck, Austria). Metabolite concentrations or combinations thereof will be compared to the outcome described above in order to identify the most suitable metabolites to be used for early detection of NE in newborn infants.
次要结局
未报告次要终点