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.
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
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
All live-born infants born before 28 weeks of gestation (extremely preterm) who were hospitalized at Montpellier University Hospital during the inclusion period and had cord blood collected immediately after birth.
Case-control
Prospective
Venous Cord blood sample
Biological/VaccineVenous 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.
Arterial cord blood sample
Biological/VaccineArterial 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.
Correlation between occurence of early severe morbidity mortality and characterization of Extracellular vesicles (EVs)
The primary outcome is the correlation between occurence of early severe morbidity mortality and the characterization of Extracellular vesicles (EVs) for venous cord blood plasma : 1. EV were isolated from venous cord blood plasma using sequential centrifugation and ultracentrifugation steps. EVs were then characterized for size (nm) and concentration (EVs/µL) using a Zetasizer, and their cellular origin was determined by nanocytometry. 2. Early severe morbidity or mortality during the hospital stay is defined as the occurrence of at least one of the following events: * Refractory shock (requiring fluid resuscitation or vasopressor support) * Pulmonary Hemorrhage * Severe Intraventricular Hemorrhage (grade 3 or 4, Papille classification) * Death before discharge
Correlation between occurrence of other morbidity before discharge and the EVs characterization
This secondary outcome will explore the correlation between the characterization of venous cord blood extracellular vesicles (EVs), as defined in the primary outcome, and the occurrence of other morbidities before discharge, defined as: * Necrotizing enterocolitis * Bronchopulmonary dysplasia * Other significant conditions
Correlation between obstetric characteristics and causes of prematurity and characterization of venous cord blood EVs.
This secondary outcome will explore the correlation between the characterization of venous cord blood extracellular vesicles (EVs), as defined in the primary outcome, and the obstetric characteristics and causes of prematurity
Comparison of Arterial and Venous Extracellular Vesicles
For the first five inclusions, an arterial blood sample will also be collected. Extracellular vesicles (EVs) from arterial and venous cord blood will be characterized for size, concentration, and cellular origin using the same methods as described for the primary outcome. Arterial and venous EV characteristics will then be compared.
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University Hospital, Montpellier
Lead sponsor
INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles
Collaborator
