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

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Bronchopulmonary Dysplasia (BPD); Death; Shock; Intraventricular Hemorrhage; Enterocolitis, Necrotizing; ELGAN (22-28SA); Pulmonary Hemorrhage; Extracellular Vesicles

Treatments: Biological: Venous Cord blood sample; Biological: Arterial cord blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT07273643

RECHMPL25_0241

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Extremely Low Gestational Age Newborns without severe morbidity or mortality

Description:

Extremely Low Gestational Age Newborns (ELGANs) born at Montpellier Hospital before 28 weeks of gestation, who were admitted to the neonatal unit, had cord blood collected at birth, and did not experience severe morbidity (early shock, intraventricular hemorrhage, or pulmonary hemorrhage) or death before discharge.

Treatment:

Biological: Arterial cord blood sample

Biological: Venous Cord blood sample

Extremely Low Gestational Age Newborns with severe morbidity or mortality

Description:

Extremely Low Gestational Age Newborns (ELGANs) born at Montpellier Hospital before 28 weeks of gestation, who were admitted to the neonatal unit, had cord blood collected at birth, and experienced severe morbidity (early shock, intraventricular hemorrhage, or pulmonary hemorrhage) or death before discharge.

Treatment:

Biological: Arterial cord blood sample

Biological: Venous Cord blood sample