RecruitingNCT07273643

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


Sponsor

University Hospital, Montpellier

Enrollment

30 participants

Start Date

Jan 13, 2026

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 0 DaysMax Age: 3 Months

Inclusion Criteria4

  • 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 Criteria3

  • 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

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Interventions

BIOLOGICALVenous Cord blood sample

Venous cord blood sample will be collected at birth (10 mL; if not possible, a minimum of 3 mL) from the umbilical vein into an EDTA tube. Plasma was isolated from blood cells by two centrifugation steps. Extracellular vesicles (EVs) were then isolated from plasma using additional centrifugation and ultracentrifugation steps. EVs were sized and counted using a Zetasizer, and their cellular origin was characterized by nanocytometry.

BIOLOGICALArterial cord blood sample

Arterial cord blood sample will be collected at birth (10 mL; if not possible, a minimum of 3 mL) from the umbilical vein into an EDTA tube for the five first inclusions (succeed). Plasma was isolated from blood cells by two centrifugation steps. Extracellular vesicles (EVs) were then isolated from plasma using additional centrifugation and ultracentrifugation steps. EVs were sized and counted using a Zetasizer, and their cellular origin was characterized by nanocytometry.


Locations(1)

CHU de Montpellier

Montpellier, France

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NCT07273643


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