[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509038":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":95,"collaborators":29,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":29,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":52,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"NHF high","EXPERIMENTAL","Nasal high flow therapy 8L\u002Fmin",[13],"Other: NHF high",{"label":15,"type":10,"description":16,"interventionNames":17},"NHF low","Nasal high flow therapy 6L\u002Fmin",[18],"Other: NHF low",{"label":20,"type":21,"description":22,"interventionNames":23},"NCPAP","ACTIVE_COMPARATOR","Nasal continuous positive airway pressure 6 cm H20",[24],"Other: NCPAP",[26,30,33],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Nasal high flow therapy 8L\u002Fmin.",[9],null,{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Nasal high flow therapy 6L\u002Fmin.",[15],{"type":6,"name":20,"description":22,"armGroupLabels":34,"otherNames":29},[20],[36],{"name":37,"affiliation":38,"role":39},"André Kidszun, Prof. Dr. med.","Division of Neonatology, Department of Pediatrics, Inselspital","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":29,"email":45},"Lisa Marie Bünte","CONTACT","+41 31 632 19 23","lisamarie.buente@insel.ch",{"name":37,"role":43,"phone":47,"phoneExt":29,"email":48},"+41 31 632 14 01","andre.kidszun@insel.ch",[50,70],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"University Medical Center of the Johannes Gutenberg-University Mainz","RECRUITING","Mainz","Rhineland-Palatinate","55131","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],8.28008,49.98185,{"lat":62,"lon":61},[65,69],{"name":66,"role":43,"phone":67,"phoneExt":29,"email":68},"Susanne Tippmann, Dr. med.","+49 6131 17 5892","Susanne.Tippmann@unimedizin-mainz.de",{"name":66,"role":39,"phone":29,"phoneExt":29,"email":29},{"facility":71,"status":52,"city":72,"state":29,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Department of Pediatrics, Inselspital","Bern","3010","Switzerland","CH",{"type":59,"coordinates":77},[78,79],7.44744,46.94809,{"lat":79,"lon":78},[82,85,86,87,89,91,93],{"name":83,"role":43,"phone":84,"phoneExt":29,"email":45},"Lisa M Bünte","+41316321923",{"name":37,"role":43,"phone":47,"phoneExt":29,"email":48},{"name":37,"role":39,"phone":29,"phoneExt":29,"email":29},{"name":83,"role":88,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"name":90,"role":88,"phone":29,"phoneExt":29,"email":29},"Thomas Riedel, Prof. Dr. med.",{"name":92,"role":88,"phone":29,"phoneExt":29,"email":29},"Thomas Riva, Prof. Dr. med.",{"name":94,"role":88,"phone":29,"phoneExt":29,"email":29},"Bubl Benedikt, Dr. med.",{"type":96,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100509038","effects-of-flow-magnitude-on-cardiorespiratory-stability-during-nasal-high-flow-therapy-in-preterm-infants-100509038",false,"NCT05908227","Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants","Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)","MASTER","Inclusion Criteria:\n\nInclusion if all apply.\n\n* Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)\n* \\>2nd day of life (defined as date day)\n* Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:\n\n  * ≤ 2 apneas with concomitant bradycardias (\\\u003C100\u002Fmin) per hour for the previous 6 hours\n  * FiO2 ≤ 0.3 and not increasing\n  * No significant chest recessions (Silverman Score \\\u003C 5)\n  * Respiratory rate ≤ 60\u002Fmin\n  * No need for intermittent positive pressure ventilation\n* Parents with an age 18+ years\n* Written parental informed consent (or other legal representative)\n\nExclusion Criteria:\n\nExclusion if any applies.\n\n* Significant fetal anomalies\n* Primary palliative care\n* Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours","ALL","23 Weeks","31 Weeks",{"count":109,"type":110},150,"ESTIMATED","INTERVENTIONAL",[113],"NA","Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.",[116],"Respiratory Distress Syndrome",[118,119],"Nasal high flow therapy","Continuous positive airway pressure","2025-02-19",{"date":122,"type":123},"2025-02-21","ACTUAL",{"date":125,"type":123},"2023-07-01",{"date":127,"type":110},"2026-02",{"name":5,"class":6},2]