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

Обзор

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.

Вмешательства

• Биопрепарат Venous 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.
• Биопрепарат Arterial cord blood sample
  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.

Первичные конечные точки

• Correlation between occurence of early severe morbidity mortality and characterization of Extracellular vesicles (EVs) [Срок оценки: 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]

Вторичные конечные точки (3)

• Correlation between occurrence of other morbidity before discharge and the EVs characterization [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• CHU de Montpellier — Montpellier

Публикации

• 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. PMID 34441255
• 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. PMID 34087976
• Galley JD, Mar P, Wang Y, Han R, Rajab A, Besner GE. Urine-derived extracellular vesicle miRNAs as possible biomarkers for and mediators of necrotizing enterocolitis: A proof of concept study. J Pediatr Surg. 2021 Nov;56(11):1966-1975. doi: 10.1016/j.jpedsurg.2021.02.016. Epub 2021 Mar 2. PMID 33785202
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• Zhong XQ, Yan Q, Chen ZG, Jia CH, Li XH, Liang ZY, Gu J, Wei HL, Lian CY, Zheng J, Cui QL. Umbilical Cord Blood-Derived Exosomes From Very Preterm Infants With Bronchopulmonary Dysplasia Impaired Endothelial Angiogenesis: Roles of Exosomal MicroRNAs. Front Cell Dev Biol. 2021 Mar 25;9:637248. doi: 10.3389/fcell.2021.637248. eCollection 2021. PMID 33842462

Идентификаторы

NCT: NCT07273643 · RECHMPL25_0241

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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