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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-3
SponsorUniversity Hospital, Montpellier

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Venous Cord blood sample
  • Arterial cord blood sample

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles

Collaborator