[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558541":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":10,"responsibleParty":30,"collaborators":33,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":10,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":10,"maxAge":10,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":10},{"fullName":5,"class":6},"McMaster Children's Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Higher Pressure",null,"Use of initial post-extubation pressures that are 2 cmH2O higher than the pre-extubation measured mean airway pressure (Paw). This can be via either CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation).\n\nHigher CPAP: Initial set Paw level on CPAP = Pre-extubation measured Paw level + 2 cmH2O\n\nHigher NIPPV: Initial set Paw level on NIPPV = Pre-extubation measured Paw level + 2 cmH2O",{"label":13,"type":10,"description":14,"interventionNames":10},"Equal\u002FLower Pressure","Use of initial post-extubation pressures that is equal to\u002Flower than the pre-extubation measured mean airway pressure (Paw). This can be via either CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation).\n\nEqual\u002FLower CPAP: Initial set Paw level on CPAP ≤ Pre-extubation measured Paw level\n\nEqual\u002FLower NIPPV: Initial set Paw level on NIPPV ≤ Pre-extubation measured Paw level",[16],{"name":17,"affiliation":18,"role":19},"Amit Mukerji, MD","McMaster University","PRINCIPAL_INVESTIGATOR",[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Heather Johnson, RN","CONTACT","905-521-2100","johnsh30@mcmaster.ca",{"name":17,"role":23,"phone":27,"phoneExt":28,"email":29},"905-21-2100","76486","mukerji@mcmaster.ca",{"type":19,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Amit Mukerji","Associate Professor and Staff Neonatologist",[34,35,38],{"name":18,"class":6},{"name":36,"class":37},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":39,"class":6},"Canadian Neonatal Network","100558541","post-extubation-pressures-in-preterm-neonates-a-cer-study-100558541",false,"NCT06552455","Post-extubation Pressures in Preterm Neonates: A CER Study","Post-extubation Pressures on Non-invasive Respiratory Support in Preterm Neonates: A Prospective Comparative Effectiveness Research Study","Inclusion Criteria:\n\n* Preterm neonates GA \\\u003C28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.\n\nExclusion Criteria:\n\n* Major chromosomal\u002Fgenetic\u002Fcongenital abnormalities\n* Never received invasive mechanical ventilation (IMV)\n* Received IMV, but never extubated to non-invasive respiratory support (NRS)\n\n  * Transferred to non-participating site while intubated\n  * Death prior to extubation\n  * Initial extubation was for withdrawal of care\n* Lack of any eligible extubation, eligible defined as ALL of the following: (i) ≥36 continuous hours on IMV; (ii) pre-extubation MAP ≤13 cmH2O; and (iii) on post-extubation NRS for ≥1 hour.","ALL",{"count":49,"type":50},1050,"ESTIMATED","OBSERVATIONAL","The optimal post-extubation pressure level on non-invasive respiratory support modes - irrespective of the choice of the specific non-invasive mode - that optimizes extubation success and improves clinical outcomes remains unknown.\n\nThe investigators aim to determine the optimal initial non-invasive pressure support level post-extubation in preterm neonates, in relation to the pre-extubation measured mean airway pressures (Paw). The hypothesis is that use of higher pressures will lead to fewer re-intubations.\n\nThis will be a prospective comparative effectiveness study across participating tertiary NICUs across Canada. Centres will self-select whether to use Higher or Equal\u002FLower pressure levels as well as the initial post-extubation mode (NIPPV or CPAP) for the study duration. Only the first eligible extubation will be included for analysis. Eligible patients \\\u003C28 weeks' gestational age at birth undergoing an eligible extubation (from a mean airway pressure \\\u003C\u002F= 13 cmH2O) will be included. The primary outcome will be re-intubation within 7 days. Secondary outcomes will include other neonatal morbidities.",[54,55,56],"Respiratory Distress Syndrome","Bronchopulmonary Dysplasia","Preterm Birth",[58,59,60,61],"Extubation Failure","Non-invasive respiratory support","Prematurity","Post-extubation pressures","NOT_YET_RECRUITING","2024-08-09",{"date":65,"type":66},"2024-08-14","ACTUAL",{"date":68,"type":50},"2024-11-01",{"date":70,"type":50},"2028-12-31",{"name":5,"class":6}]