Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Correlation between occurence of early severe morbidity mortality and characterization of Extracellular vesicles (EVs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Venous Cord blood sample (Biological)
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.
干预措施: Arterial cord blood sample (Biological)
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.
干预措施: Venous Cord blood sample (Biological)
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.
干预措施: Arterial cord blood sample (Biological)
结局指标
主要结局
Correlation between occurence of early severe morbidity mortality and characterization of Extracellular vesicles (EVs)
时间窗: 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
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
次要结局
- Correlation between occurrence of other morbidity before discharge and the EVs characterization(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.(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(Blood collection: at birth Centrifugation: within 3 hours of collection. EV isolation and analysis: up to there month after collection.)