NCT07273643 Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
| NCT ID | NCT07273643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Intraventricular Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2027-10-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2026-01-13 with a primary completion date of 2027-10-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation. EVs are tiny particles released by cells that carry important information about the body's condition. In extremely premature infants, blood vessels may not function properly, leading to serious health problems such as bleeding in the brain, lung injury, or severe infections. Researchers believe that analyzing EVs in the umbilical cord blood of these infants may help predict which babies are at higher risk of developing these complications. By studying the size, number, and type of EVs, the team hopes to identify early markers that can guide doctors in providing better care. The study will collect cord blood from 30 eligible infants born at the CHU of Montpellier. Blood samples will be processed to isolate platelet-poor plasma, which contains EVs. This plasma will be stored in a biobank, allowing future research on EVs and their role in extreme prematurity. EVs will then be analyzed in the laboratory to assess their characteristics and any links to severe health issues. The findings from this study could improve understanding of circulatory problems in extremely premature infants, help identify early predictors of severe complications, and inform better monitoring and treatment strategies. The creation of a plasma biobank also provides a valuable resource for future research to enhance care and outcomes for this vulnerable population.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07273643 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 3 Months, studying Intraventricular Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07273643 currently recruiting?
Yes, NCT07273643 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Montpellier to inquire about joining.
Where is the NCT07273643 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT07273643 clinical trial?
NCT07273643 is sponsored by University Hospital, Montpellier. The trial plans to enroll 30 participants.