[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533361":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Hospital Universitario 12 de Octubre","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"3D Mask (3DM)","EXPERIMENTAL","Custom 3D mask (3DM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.",[13,14],"Device: Custom 3D mask (3DM) application in neonate","Device: Traditional mask (TM) application in neonate",{"label":16,"type":17,"description":18,"interventionNames":19},"Traditional Mask (TM)","ACTIVE_COMPARATOR","Traditional Mask (TM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Custom 3D mask (3DM) application in neonate","Premature infants with a birth weight less than 1500 g r first received 3D mask during 4 hour, then crossed over to traditional mask.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Traditional mask (TM) application in neonate","Premature infants with a birth weight less than 1500 g r first received traditional mask during 4 hours, then crossed over to 3D mask.",[9,16],[32,35],{"name":33,"affiliation":5,"role":34},"María Teresa Moral Pumarega","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Antonio Martín González, Mechanical Engineering","STUDY_CHAIR",[39],{"name":33,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","649921733","+34","mmoralp@salud.madrid.org",[45],{"facility":5,"status":46,"city":47,"state":26,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Madrid","28041","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],-3.70256,40.4165,{"lat":55,"lon":54},[58],{"name":59,"role":40,"phone":41,"phoneExt":42,"email":43},"Maria Teresa Moral Pumarega",{"type":34,"investigatorFullName":33,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor of Pediatrics at the Complutense University of Madrid (UCM)",[63],{"name":64,"class":65},"ISCIII","UNKNOWN","100533361","clinical-trial-for-the-evaluation-of-customized-3d-printed-niv-nasal-masks-in-premature-infants-100533361",false,"NCT06224816","Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants","Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants","M3DPREMAT","Inclusion Criteria:\n\n* Newborn prematurity\n* Age: less than 30 days of life\n* Required respiratory support with non-invasive ventilation (NIV)\n* Premature infant has not been on NIV for more than 3 days before being included in the trial.\n* Signature of the Informed Consent (IC)\n\nExclusion Criteria:\n\n* Failure to meet entry criteria\n* Cyanotic congenital heart disease diagnosis\n* Presence of serious malformations\n* Presence of airway malformations","ALL","0 Days","30 Days",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).\n\nPremature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.\n\nTo compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm \\\u003C 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and\u002For sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.",[85],"Premature Lungs",[87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Neonatology","Nasal mask","3D printing","Additive manufacturing","Newborn","Premature","Prematurity","Neonate","Non-Invasive Ventilation (NIV)","Oxygen saturation","SolidWorks","3D scanner","Customized device","Continuous positive airway pressure (CPAP)","2024-04-16",{"date":103,"type":104},"2024-04-18","ACTUAL",{"date":101,"type":104},{"date":107,"type":79},"2026-12",{"name":5,"class":6},1]