Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality

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.

NCT Number	NCT07273643
Lead Sponsor	University Hospital, Montpellier Collaborators: INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles
Conditions	Intraventricular Hemorrhage, Pulmonary Hemorrhage, Death, ELGAN (22-28SA), Bronchopulmonary Dysplasia (BPD), Shock, Extracellular Vesicles, Enterocolitis, Necrotizing
Enrollment	30 participants
Start Date	2026-01-13
Primary Completion	2027-10-13 (estimated)
Study Completion	2027-10-13 (estimated)
Updated on ClinicalTrials.gov	2026-02-23