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临床试验/NCT04714775
NCT04714775Unknown不适用

Validation of Biomarkers of Adverse Neurologic Outcome in Newborns at Risk for Perinatal Brain Injury - Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test

InfanDx AG13 个研究点 分布在 2 个国家目标入组 500 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
13
主要终点
participants with normal neuro-developmental status

研究概览

简要总结

Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data 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 and a preliminary human study.

详细描述

Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): The aim of the study is to validate 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, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

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

入选标准

  • Infants previously enrolled in BANON study

排除标准

  • Missing valid written informed parental consent

结局指标

主要结局

participants with normal neuro-developmental status

时间窗: up to 42 month age

all infants with normal neuro-developmental status

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

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 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

次要结局

未报告次要终点

研究者

发起方
InfanDx AG
申办方类型
Industry
责任方
Sponsor

研究点 (13)

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