[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"elgan-22-28sa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:elgan-22-28sa":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":18,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100613980","characterization-of-extracellular-vesicles-from-the-cord-blood-of-extremely-preterm-new-borns-and-their-correlation-with-severe-morbidity-and-mortality-100613980",false,"NCT07273643","Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality","VEEP","Inclusion Criteria:\n\n* Mother over 18 years old, able to speak and understand French\n* Newborn less than 28 weeks of gestation, born and hospitalized at Montpellier University Hospital\n* 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.\n* Parental non-opposition to the study obtained before sample collection\n\nExclusion Criteria:\n\n* Stillborn infant\n* Handling failure: failure to collect the sample or start the first centrifugation more than 3 hours after birth\n* 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","0 Days","3 Months",{"count":20,"type":21},30,"ESTIMATED","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.\n\nResearchers 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.\n\nThe 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.\n\nThe 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.",[25,26,27,28,29,30,31,32],"Intraventricular Hemorrhage","Pulmonary Hemorrhage","Death","ELGAN (22-28SA)","Bronchopulmonary Dysplasia (BPD)","Shock","Extracellular Vesicles","Enterocolitis, Necrotizing",[34,35,36,37,38,39,40],"ELGAN","Extremely Low Gestational Age Newborn (ELGAN)","Extracellular vesicles","EVs","Intraventricular hemorrage","Pulmonary hemorrhage","Bronchopulmonary Dysplasia","RECRUITING","2026-02-19",{"date":44,"type":45},"2026-02-23","ACTUAL",{"date":47,"type":45},"2026-01-13",{"date":49,"type":21},"2027-10-13",{"name":51,"class":52},"University Hospital, Montpellier","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100597402","phase-2-mesenchymal-stromal-cell-therapy-to-prevent-bronchopulmonary-dysplasia-in-extreme-preterm-infants-100597402","NCT07058025","Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants","Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - A Phase 2 Multi-Centre Double Blind Randomized Controlled Trial","HULC-2","Inclusion Criteria:\n\n* Gestational age (GA) less than 28+0 weeks\n* Post-natal age between 4 and 14 days of life\n* Invasive ventilation with oxygen requirement:\n\n  * On mechanical ventilation: intubated patient with any of the following ventilation modes: conventional, HFO or Jet ventilation:\n  * With requirement of FiO2: FiO2 \\>= 30% and for at least 12 hours over 24 hours (i.e. flowsheets, FiO2 histogram)\n\nExclusion Criteria:\n\n1. Congenital anomaly:\n\n   * Genetic and chromosomal syndromes (e.g., Trisomy 13, Trisomy 18, Trisomy 21): either patient with high suspicion (antenatal findings, clinical features) or documented syndrome by genetic testing.\n   * Major congenital anomalies including cardiac (i.e., congenital heart defects, NB. PDA is not considered an exclusion criterion), neurological (e.g., holoprosencephaly, anencephaly), gastrointestinal (e.g., gastroschisis, omphalocele), pulmonary (e.g., congenital diaphragmatic hernia) anomalies.\n   * Inborn errors of metabolism.\n2. Hemodynamic instability (shock):\n\n   * Hemodynamic instability with impaired end-organ perfusion (metabolic acidosis with increased lactate and\u002For decreased urine output).\n   * Requirements for fluid bolus, inotrope or vasopressor medication\n3. Severe sepsis:\n\n   * Signs of hemodynamic instability and requiring at least one fluid bolus.\n   * And a positive blood or cerebrospinal fluid culture.\n4. Pneumothorax: Pneumothorax with a chest tube in place\n5. Severe pulmonary hemorrhage:\n\n   * Active pulmonary hemorrhage (i.e., frank blood coming from the endotracheal tube.\n   * And at least one of the following criteria: a)hemodynamic instability. b) blood product transfusion (packed red blood cells, platelets, fresh frozen plasma)\n6. Extubation: If Extubation planned within the next 24 hours (post first uc-MSC administration\u002Fsham procedure).\n7. Patient is not expected to survive:\n\n   * Redirection of care.\n   * Patient is moribund","4 Days","14 Days",{"count":65,"type":21},168,"INTERVENTIONAL",[68],"PHASE2","This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.\n\nStudy participants will receive either multiple intravenous doses (total of 3 doses) of MSC derived from human donor umbilical cord tissue (intervention group) or no uc-MSC injection (control group) to confirm the safety of IV MSC in extreme preterm infants and evaluate the potential benefit of MSC therapy on their respiratory health as well as on other complications related to preterm birth.",[29,28],[72,73,74,75,40,76],"Phase II clinical trial","Mesenchymal stromal cell","Cell therapy","Preterm infant","Extremely low gestational age neonates","NOT_YET_RECRUITING","2025-07-08",{"date":80,"type":45},"2025-07-10",{"date":82,"type":21},"2025-10-01",{"date":84,"type":21},"2038-09-30",{"name":86,"class":52},"Ottawa Hospital Research Institute",8,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":53},"100572799","cardiovascular-immaturity-in-extremely-low-gestational-age-newborns-a-fundamental-prospective-study-100572799","NCT06737965","Cardiovascular Immaturity in Extremely Low Gestational Age Newborns: a Fundamental Prospective Study","ELGAN AMINES","Inclusion Criteria:\n\nFor the pregnant women:\n\n* Over 18 years old.\n* Speaks and understands French.\n* Medical abortion requested by the participant, scheduled and validated by the CPDPN of the Montpellier University Hospital.\n* Participant's agreement to use for research purposes the biological tissues from the systematic foetopathological examination.\n\nFor fetuses:\n\n* Interest group: Fœtus ≥ 22 WA and \\\u003C28 WA\n* Control group: Fœtus ≥ 34 WA\n\nExclusion Criteria:\n\nFor the pregnant women :\n\n* Injection of betamethasone or maternal use of dexamethasone in the month before foeticide\n* Known family genetic mutation that may be linked with cardiomyopathy\n* Failure to obtain consent (adults, unemancipated minors, persons unable to give consent)\n* Not affiliated to a social security\n* Persons under legal protection\n* Person taking part in another research study with an exclusion period still in progress.\n\nFor fetuses:\n\n* Fetus from unplanned in-utero death\n* Significant cardiac malformation suspected antenatally (excluding atrial septal defect ostium secundum and isolated muscular ventricular septal defect).\n* Suspected abnormality of myocardial tissue\n* Biological tissue sampling more than 48 hours after fœticide","18 Years",{"count":97,"type":21},15,"Birth is a major turning point in the life of the newborn, as it moves from intrauterine life to extrauterine life. This sudden transition forces the newborn to adapt quickly. Oxygenation, which was only provided by the placenta during uterine life, will have to be provided by the lungs, which will open when the newborn cries for the first time. This phenomenon will change the way blood reaches the lungs and will require the newborn's heart to work harder. In addition, the cardiac workload will also increase due to the clamping of the umbilical cord, which will force the heart to pump through more resistant blood vessels.\n\nThis transition, generally well tolerated in newborns at term, can be much more complicated in premature newborns, particularly in extremely low gestational age newborns (e.g. ELGAN, born before 28 weeks of amenorrhoea). There are several causes of this difficult adaptation on the cardiovascular system: poor heart function, difficulty in revascularizing lungs due to the physiological characteristics of premature newborns (high pulmonary vascular resistance, persistence of the ductus arteriosus), and a tone of the blood vessel muscles that is probably immature. In addition, respiratory failure is often associated with pulmonary immaturity.\n\nThe consequences of a difficult adaptation to extrauterine life, combined with cardiovascular failure, will be poor organ perfusion, whose brain. Moreover, ELGANs have immature regulation of their brain vascularisation. Variations in the vascularisation of the brain (in the event of cardiovascular failure) may be responsible for irreversible lesions with intraventricular hemorrhage. Ultimately, these bleedings carry a high risk of mortality or severe disability in premature infants.\n\nSeveral hypotheses have been put forward as to the causes of this poor adaptation to extrauterine life, but there are few recommendations on adapted medical management. Cardiac ultrasound and the use of drugs to support the heart and blood vessels have been suggested. However, a large number of ELGANs will develop complications that investigators cannot predict or intervene in time. In addition, studies on the drugs used have not been carried out on ELGANs, which limits the conclusions investigators can draw.\n\nThese factors encourage us to improve our fundamental knowledge of the cardiovascular system in the ELGANs. The aim is to identify the most effective clinical tools and treatments for assessing and treating neonatal cardiovascular failure at an early stage, before complications appear. Investigators aim to compare the architecture and composition of the heart, blood vessels, and blood of fetuses under 28 weeks of amenorrhea gestation with those of fetuses over or equal to 34 weeks of amenorrhea gestation.\n\nFor this research, investigators need tissues (heart muscle, blood, and vessels) from fetuses of different ages. These tissues are usually already taken during the foetopathology examination to try to provide a medical explanation of the medical abortion. There will be no change to the foetopathology examination carried out on the foetus, with the exception that some of the tissue taken will have additional analyses carried out in our INSERM laboratory attached to the Montpellier University Hospital.\n\nPopulation resulting from medical abortion is motivated by the ethical impossibility of taking such invasive samples from live newborns. The non-use of animals is justified by the difficulty of extrapolating results to humans. The indication for abortion and its performance will be carried out by current practice. Participants will be offered and explained the study during the pre abortion visit.\n\nThis research does not alter the patient's care. No additional examination or consultation is required. No personal benefit is expected from the study, but it will enable us to gain a better understanding of ELGAN's hemodynamics and to consider future clinical studies.",[28,100,101],"Extremely Low Gestational Age Newborns","Cardiovascular Immaturity",[103,104,105,106,107,108,109,110,111],"Cardiovascular immaturity in extremely premature infants","vasoactive agent","vascular reactivity","cardiac adrenergic receptor","cardiac architecture","vascular response","Extremely low gestational age newborns","cardio-circulatory insufficiency","myocardial contraction","2024-12-12",{"date":114,"type":45},"2024-12-17",{"date":116,"type":21},"2025-01-01",{"date":118,"type":21},"2025-12-31",{"name":51,"class":52}]