Simple cord blood test may spot brain bleed risk in tiny preemies
NCT ID NCT02400853
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at whether measuring certain substances in the cord blood of very premature babies (born before 30 weeks) can predict if they will develop bleeding in the brain. Researchers measured levels of a complex called t-PA-PAI-1 and other markers in 175 infants. The goal is to identify high-risk babies at birth so doctors can take steps to prevent bleeding.
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 way to identify preterm infants at high risk of brain bleeding right after birth, allowing early preventive care.
- What could go wrong
- This is a small, completed observational study, not a treatment trial. The findings may not lead to a reliable test or change clinical practice without further validation.
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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175 people
The number who actually took part.
- Started
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Jul 2015
- Finished
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Apr 2020
- 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 to 1 day
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Alive preterm infants between 24 weeks gestation and 29 weeks and 6 days * Infants of both sexes * Children whose parents signed a free and informed consent after oral information by one of the study investigators * Exact term (pregnancy onset evaluated by the craniocaudal length or the date of the puncture in a medical assisted reproduction) * Children with social protection Exclusion Criteria: * Maternal taking of antiplatelet therapy or anticoagulation within 48 hours of birth * Acquired maternal disease constituting a risk factor for neonatal hemorrhage * Constitutional maternal disease constituting a risk factor for neonatal hemorrhage * Severe fetal malformation * Cesarean birth after diagnosis of hydrocephalus detected in utero * Minors parents * History of mental disease,or sensory abnormality of one of the parents, which can lead to confusion about the study
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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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Rouen University Hospital
Rouen, 76031, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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