Looking at tiny particles in cord blood of babies born before 28 weeks
Official title: Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
Run by University Hospital, Montpellier · NCT07273643 · Data updated 2026-11-12
The team will test whether extracellular vesicles in umbilical cord blood can help predict serious complications in babies born before 28 weeks of pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 3 Months |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | January 13, 2026 |
| Main results expected | October 13, 2027 |
| Study ends | October 13, 2027 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT07273643 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Eligible patients are newborns delivered before 28 weeks of gestation at Montpellier University Hospital whose parents do not object to cord blood collection and where sufficient cord blood can be obtained.
✕Probably not a fit
Infants born at other hospitals, born at or after 28 weeks, stillborn cases, or cases where cord blood cannot be collected or processed in time are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will collect umbilical cord blood from about 30 extremely preterm infants born at CHU de Montpellier and process samples to obtain platelet-poor plasma for extracellular vesicle (EV) analysis. Researchers will measure EV size, number, and subtypes and correlate these features with severe outcomes such as intraventricular hemorrhage, pulmonary hemorrhage, bronchopulmonary dysplasia, and death. Samples will be stored in a biobank to enable future EV research and validation work. The goal is to identify early blood-based markers present at birth that relate to later morbidity and mortality in ELGANs.
Why it matters
Potential benefit: If successful, this work could provide early markers at birth that help clinicians identify extremely preterm infants at higher risk for severe complications so care can be targeted sooner.
How similar studies have gone: Early research indicates EVs reflect inflammation and tissue injury, but using cord-blood EVs to predict outcomes in extremely preterm infants remains largely exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mother over 18 years old, able to speak and understand French * Newborn less than 28 weeks of gestation, born and hospitalized at Montpellier University Hospital * Umbilical cord venous blood collected immediately after birth (from the segment between the cord clamp and the placenta), with a volume of 10 ml (which can be reduced to 3 ml if collection is difficult) into an EDTA tube. * Parental non-opposition to the study obtained before sample collection Exclusion Criteria: * Stillborn infant * Handling failure: failure to collect the sample or start the first centrifugation more than 3 hours after birth * General regulatory criteria: failure to obtain parental non-opposition, lack of social security coverage, individuals under legal guardianship, or participation in another ongoing research study with an active exclusion period
Where it's running
-
CHU de Montpellier
Montpellier, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.