Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- variation of Cognitive development in the three populations
研究概览
简要总结
Current diagnostic methods rely primarily on clinical symptoms, supplemented by brain imaging and physiological tests. However, these signs of injury only become apparent once significant damage has occurred, thus delaying intervention and compromising the effectiveness of treatments. Therefore, there is a need to develop new markers to develop preventive measures for the consequences of perinatal asphyxia.
The primary objective is to compare cognitive and motor development at 18 months in three populations (PA, at risk of PA, and Control) defined on the basis of clinical, biological, and neural criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Perinatal Asphyxia Cohort:
- •The non-PA cohort includes:
- •Full-term infants (born between 36 and 42 weeks of gestation), clinically "normal" and without PA. Infants must have birth weights within the normal range for their gestational age.
- •Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.
- •Meet specific biochemical biomarker criteria as defined by the study protocols.
- •No major complications should occur during pregnancy or delivery.
- •At-Risk Perinatal Asphyxia Cohort:
- •The at-risk PA cohort includes newborns who are:
- •Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA,
- •Classified as such based on biochemical markers identified in WP1 (see WP1).
- •Confirmed Perinatal Asphyxia Cohort:
- •The PA cohort includes:
- •Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA.
- •Birth weight must be ≥ 1800 g.
- •Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties.
- •Specific biochemical markers indicative of PA must be present
排除标准
- •Full-term newborn not meeting inclusion criteria
研究组 & 干预措施
Confirmed Perinatal Asphyxia
- Newborns diagnosed with PA and treated with hypothermia. The inclusion criteria for this group allow for various modes of delivery, complications during pregnancy and delivery, and a range of gestational ages, as long as they meet the criteria for PA.
- Birth weight must be ≥ 1800 g.
- Apgar scores at 1, 3, and 5 minutes must indicate potential complications or difficulties.
- Specific biochemical markers indicative of PA must be present
干预措施: EEG (Device)
Non-Perinatal Asphyxia
- Full-term infants (born between 36 and 42 weeks of gestation), clinically "normal" and without PA. Infants must have birth weights within the normal range for their gestational age.
- Satisfactory Apgar scores at 1, 3, and 5 minutes, indicating good health.
- Meet specific biochemical biomarker criteria as defined by the study protocols.
- No major complications should occur during pregnancy or delivery.
干预措施: EEG (Device)
At-Risk Perinatal Asphyxia
The at-risk PA cohort includes newborns who are:
- Identified by healthcare professionals as being at risk based on criteria that do not exceed the diagnostic thresholds for PA but whose combined assessment of maternal, fetal, and neonatal medical criteria suggests risk factors and early signs of potential PA,
- OR
- Classified as such based on biochemical markers identified in WP1 (see WP1)
干预措施: EEG (Device)
结局指标
主要结局
variation of Cognitive development in the three populations
时间窗: at 18 months
variation of Cognitive development in the three populations (PA, at risk of PA, and Control) Cognitive development is determined with EEG, eye tracking and questionnaire
variation of motor development in the three populations
时间窗: at 18 months
variation of motor development in the three populations (PA, at risk of PA, and Control) motor development is determined by mouvement analysis
次要结局
- Identification of biochemical and protein markers of PA(at 18 months)
- Identification of EEG markers of PA(at 18 months)
- correlation between biochemical, protein, and EEG markers(at 18 months)
- correlation between biochemical markers at birth and behavioral measurements at 18 months(at 18 months)