Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia (NCT07702500) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
France280 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
1 Day
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Full-term newborn not meeting in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
variation of Cognitive development in the three populations
Timeframe: at 18 months
2
variation of motor development in the three populations