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| Name | Class |
|---|---|
| INSERM U1046 Physiologie et médecine expérimentale du coeur et des muscles | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extremely Low Gestational Age Newborns without severe morbidity or mortality | 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. |
| |
| Extremely Low Gestational Age Newborns with severe morbidity or mortality | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous Cord blood sample | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Recruiting | Montpellier | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34441255 | Background | Pekarkova K, Soukup J, Kostelanska M, Sirc J, Stranak Z, Holada K. Cord Blood Extracellular Vesicles Analyzed by Flow Cytometry with Thresholding Using 405 nm or 488 nm Laser Leads to Concurrent Results. Diagnostics (Basel). 2021 Jul 22;11(8):1320. doi: 10.3390/diagnostics11081320. | |
| 34087976 | Background | Hujacova A, Brozova T, Mosko T, Kostelanska M, Stranak Z, Holada K. Platelet Extracellular Vesicles in Cord Blood of Term and Preterm Newborns Assayed by Flow Cytometry: the Effect of Delay in Sample Preparation and of Sample Freezing. Folia Biol (Praha). 2020;66(5-6):204-211. doi: 10.14712/fb2020066050204. |
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Blood samples will be centrifuged to remove blood cells and obtain plasma, which will be frozen for later analysis of extracellular vesicles (EVs). These samples will be stored for at least five years. Future studies, such as microRNA analysis, functional tests, or microscopic visualization, may also be performed. All of this sample will be anonymized.
|
|
| Arterial cord blood sample | Biological | 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. |
|
|
| 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 | 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. | Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection. |
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| 18723433 | Background | Mostefai HA, Meziani F, Mastronardi ML, Agouni A, Heymes C, Sargentini C, Asfar P, Martinez MC, Andriantsitohaina R. Circulating microparticles from patients with septic shock exert protective role in vascular function. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1148-55. doi: 10.1164/rccm.200712-1835OC. Epub 2008 Aug 21. |
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| ID | Term |
|---|---|
| D003643 | Death |
| D001997 | Bronchopulmonary Dysplasia |
| D012769 | Shock |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided