Набор скоро начнётся NCT07702500

Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia

Без фазы С лечением Neonate Asphyxia EEG Eye Tracking

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: EEG.
Кому может быть актуально: Состояния в реестре: Neonate, Asphyxia, EEG, Eye Tracking. Базовые параметры: от 1 Day · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Вмешательства

Устройство EEG
electroencephalogram

Первичные конечные точки

variation of Cognitive development in the three populations [Срок оценки: at 18 months]
variation of motor development in the three populations [Срок оценки: at 18 months]

Вторичные конечные точки (4)

Identification of biochemical and protein markers of PA [Срок оценки: at 18 months]
Identification of EEG markers of PA [Срок оценки: at 18 months]
correlation between biochemical, protein, and EEG markers [Срок оценки: at 18 months]
correlation between biochemical markers at birth and behavioral measurements at 18 months [Срок оценки: at 18 months]

Критерии участия

Критерии включения

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,
OR
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