Blood marker may flag infants at risk for sudden death
NCT ID NCT03278977
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This study investigates whether a specific molecule (M2R) in the blood can identify infants under one year old who are at risk for apparent life-threatening events (ALTE), which can lead to severe complications or sudden death. Researchers will compare blood samples from infants who have experienced severe, unexplained ALTE with those from healthy infants and infants with known causes for their event. The goal is to validate M2R as a risk marker, potentially enabling earlier diagnosis and prevention.
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 a simple blood test to identify infants at risk for life-threatening events, potentially preventing sudden infant death.
- What could go wrong
- This is a small, early-stage study with only 12 infants. The blood marker may not prove reliable enough for widespread use, and more research will be needed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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12 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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May 2022
- 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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28 days to 12 months
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Infant aged between 28 days and 12 months, presenting severe syncope(s) requiring medical management, hospitalized in a pediatric intensive care unit or pediatric emergencies * Consent signed and dated by the legal representatives * Patients affiliated to a social security system Exclusion Criteria: * Infant with known cardiovascular, neurologic, infectious, toxic or metabolic pathologies before enrollment (before the syncope) * Subject on medication for more than 3 months before enrollment * Impossibility to clearly inform the legal representatives (comprehension problems) * Subject in exclusion period for clinical trial (previous or current study)
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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.
Contacts and locations
Locations
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Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital
Nancy, 54500, France
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Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital
Besançon, 25030, France
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Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital
Strasbourg, 67200, France
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Pediatric unit - Maison Blanche Hospital - Reims University Hospital
Reims, 51092, France