An observational study in Intraventricular Hemorrhage, Pulmonary Hemorrhage and Death, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 0 Days to 3 Months. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by University Hospital, Montpellier · Observational
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 30 is below the median of 400 across 236 observational studies indexed under Death.
Browse Death studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
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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.
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Exclusion Criteria:
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.
Biological: Venous Cord blood sample · Biological: Arterial cord blood sample
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.
Biological: Venous Cord blood sample · Biological: Arterial 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.
Also known as: EVs extraction and characterization, Blood centrifugation
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.
Also known as: EVs extraction and characterization, Blood centrifugation
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
Time frame: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations(occurence of early severe morbidity and mortality): through study completion, up to 1year
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
Time frame: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations (occurence of other morbidity): through study completion, up to 1year.
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
Time frame: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. Clinical informations (obstetric characteristics and causes of prematurity): through study completion, up to 1year
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.
Time frame: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection.
Started Jan 2026 (actual). Primary completion is estimated for Oct 2027, 21 months after the start.
Of 84 non-industry observational studies under Death, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 245. This study's planned 21 months is below that.
Counting every sponsor, half of 87 studies reached it within 60 months; a quarter within 23 and three quarters within 245.
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