New Eye-Tracking and brain wave tests could spot newborn brain injury hours earlier
NCT ID NCT07702500
First seen Jul 14, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study looks for early signs of brain injury in newborns who experienced oxygen deprivation at birth (perinatal asphyxia). Researchers will use EEG brain wave monitoring and eye-tracking tests, along with blood markers, to see if they can detect damage sooner than current methods. The goal is to compare development at 18 months in three groups: babies with asphyxia, those at risk, and healthy controls.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to earlier detection of brain injury in newborns, allowing faster treatment and better long-term development.
- What could go wrong
- This is an observational study, so it won't test a treatment. The biomarkers may not prove reliable enough for routine use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 day and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 inclusion criteria
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Amiens
Amiens, 80054, France
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