Verification of Biomarkers to Examine Neonatal Asphyxia-induced Hypoxic-ischemic Encephalopathy Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Participants with abnormal neuro-developmental status - non-HIE
研究概览
简要总结
Follow-up of participants of AAMBI1 study at age of at least 2 years. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
Follow-Up on neuro-developmental status of Study participants of AAMBI1. AAMBI1(ClinicalTrials.gov ID: NCT03354208): 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
- 22 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants previously enrolled in the AAMBI1 study
排除标准
- •Missing valid written informed parental consent
结局指标
主要结局
Participants with abnormal neuro-developmental status - non-HIE
时间窗: up to 42 month age
Presence of adverse 2 years neuro-developmental Outcome not attributable to perinatal hypoxic-ischemic brain injury
Participants with normal neuro-developmental status
时间窗: up to 42 month age
All infants with normal neuro-developmental status
Participants with abnormal neuro-developmental status - HIE
时间窗: up to 42 month age
Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury
Participants with potentially abnormal neuro-developmental status
时间窗: up to 42 month age
All infants who do not fulfill outcomes 1, 3 or 4
次要结局
未报告次要终点