[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541796":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":41,"locations":51,"responsibleParty":125,"collaborators":18,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":18,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":153,"whyStopped":18,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Centre Hospitalier Intercommunal Creteil","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Tracheal Gas Insufflation","EXPERIMENTAL","the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation",[13],"Device: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard ventilation without CTGI","NO_INTERVENTION","In the No Intervention arm, the preterm infants are mechanically ventilated using standard ventilation, without the CTGI-device. There is no dead space washout.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)","The intervention involves adding a device which allows CTGI (the \"CTGI-device\") to washout the dead space in preterm mechanically ventilated infants. Dead space washout using the CTGI-device is an option added to standard ventilation, to reduce or even cancel anatomical dead space due to respiratory prostheses in intubated preterm infants.",[9],[9,26],"CTGI",[28,32,35,38],{"name":29,"affiliation":30,"role":31},"Juliana PATKAI, MD","CHU Cochin-Port Royal","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Valérie BIRAN, MD, PhD","CHU Robert Debré",{"name":36,"affiliation":37,"role":31},"Cyril FLAMANT, MD, PhD","Nantes University Hospital",{"name":39,"affiliation":40,"role":31},"Fabrice DECOBERT, MD","CHI de Créteil",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":18,"email":46},"Claude Danan, M.D.","CONTACT","+33609187562","claude.danan@chicreteil.fr",{"name":48,"role":44,"phone":49,"phoneExt":18,"email":50},"Camille Jung, MD, PhD","+33157022268","camille.jung@chicreteil.fr",[52,74,93,108],{"facility":53,"status":18,"city":54,"state":18,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Centre Hospitalier Intercommunal de Creteil","Créteil","94010","France","FR",{"type":59,"coordinates":60},"Point",[61,62],2.46569,48.79266,{"lat":62,"lon":61},[65,69,73],{"name":66,"role":44,"phone":67,"phoneExt":18,"email":68},"Fabrice Decobert, MD","+33","fabrice.decobert@chicreteil.fr",{"name":70,"role":44,"phone":71,"phoneExt":18,"email":72},"laurence caeymaex, MD PhD","+33664095607","laurence.caeymaex@gmail.com",{"name":66,"role":44,"phone":18,"phoneExt":18,"email":18},{"facility":75,"status":18,"city":76,"state":18,"zip":77,"country":56,"countryCode":57,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Centre Hospitalier Universitaire de Nantes","Nantes","44000",{"type":59,"coordinates":79},[80,81],-1.55336,47.21725,{"lat":81,"lon":80},[84,88,91],{"name":85,"role":44,"phone":86,"phoneExt":18,"email":87},"Cyril Flamant, MD PhD","+33240083483","cyril.flamant@chu-nantes.fr",{"name":89,"role":44,"phone":86,"phoneExt":18,"email":90},"Geraldine Apprioual, MD","geraldine.apprioual@chu-nantes.fr",{"name":92,"role":44,"phone":18,"phoneExt":18,"email":18},"cyril flamant, MD PhD",{"facility":94,"status":18,"city":95,"state":18,"zip":96,"country":56,"countryCode":57,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Centre Hopistalier Universitaire Cochin Port Royal aphp","Paris","75014",{"type":59,"coordinates":98},[99,100],2.3488,48.85341,{"lat":100,"lon":99},[103,107],{"name":104,"role":44,"phone":105,"phoneExt":18,"email":106},"Juliana Patkai, MD","+33158413645","juliana.patkai@aphp.fr",{"name":104,"role":44,"phone":18,"phoneExt":18,"email":18},{"facility":109,"status":18,"city":95,"state":18,"zip":110,"country":56,"countryCode":57,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Centre hospitalier Robert Debré aphp","75019",{"type":59,"coordinates":112},[99,100],{"lat":100,"lon":99},[115,119,123],{"name":116,"role":44,"phone":117,"phoneExt":18,"email":118},"Valerie Biran, MD PhD","+33140034191","valerie.biran@aphp.fr",{"name":120,"role":44,"phone":121,"phoneExt":18,"email":122},"Nizar Khattat, MD","+33140031331","nizar.khattat@aphp.fr",{"name":124,"role":44,"phone":18,"phoneExt":18,"email":18},"valerie biran, MD PhD",{"type":126,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100541796","ventilation-of-the-extremely-premature-infants-optimized-by-dead-space-washout-100541796",false,"NCT06334523","Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout","Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants","Volem","Inclusion Criteria:\n\n* Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days\n* Age between 0 and 7 days of life\n* Need for intubation and mechanical ventilation before day 8 of life\n* Availability of the Research-associated medical devices\n* Beneficiary of a social security system (in France: CMU or securité sociale)\n* Parental consent for their infant to participate in this trial\n\nExclusion Criteria:\n\n* Known Severe Congenital Malformation (potential life-threatening malformation)\n* Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and\u002For other brain abnormality that can alter life prognosis\n* Known Genetic Disorder (potential life-threatening malformation)\n* Preexistent mechanical ventilation for a duration of more than 12 hours\n* Participation in another interventional research trial before inclusion","ALL","7 Days",{"count":138,"type":139},144,"ESTIMATED","INTERVENTIONAL",[142],"NA","The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L\u002Fminute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation.\n\nThe goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are:\n\n* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation?\n* Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and\u002For oxygen supplementation.\n\nResearchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence.\n\nParticipants will:\n\n• Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.",[145,9,146,147,148],"Extremely Low Birthweight Infant","Medical Device","Lung Protection","Ventilator-Induced Lung Injury",[150,151,148,152],"lung protection","extremely low birthweight infant","mechanical ventilation","NOT_YET_RECRUITING","2025-02-03",{"date":156,"type":157},"2025-02-05","ACTUAL",{"date":159,"type":139},"2025-02-13",{"date":161,"type":139},"2029-04-03",{"name":5,"class":6},4]