[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555503":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":35,"locations":42,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"cardiac hemodynamics and respiratory status assessment with increasing PEEP","EXPERIMENTAL","Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - increase followed by decrease in PEEP.\n\nBaseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT",[13],"Other: Increase in the PEEP followed by decrease in the PEEP",{"label":15,"type":16,"description":17,"interventionNames":18},"cardiac hemodynamics and respiratory status assessment with decreasing PEEP","ACTIVE_COMPARATOR","Infants will be randomized to the order of changes in PEEP levels during mechanical ventilation - decrease followed by increase in PEEP.\n\nBaseline parameters looking into cardiac hemodynamics as well as compliance and respiratory mechanics will be assessed using EIT",[19],"Other: Decrease in the PEEP followed by increase in the PEEP",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Increase in the PEEP followed by decrease in the PEEP","Changes in the ventilator PEEP and its effect on lung and cardiac hemodynamics",[9],null,{"type":6,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Decrease in the PEEP followed by increase in the PEEP",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Kulsajan S Bhatia, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"Colm P Travers, MD",[36,40],{"name":31,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","9172149882","ksbhatia@uabmc.edu",{"name":34,"role":37,"phone":25,"phoneExt":25,"email":41},"cptravers@uabmc.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"Univerisity of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.80249,33.52066,{"lat":55,"lon":54},{"type":32,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Kulsajan Singh Bhatia","Neonatal Perinatal Fellow","100555503","ventilator-pressure-and-optimization-of-compliance-and-hemodynamics-100555503",false,"NCT06512935","Ventilator Pressure and Optimization of Compliance and Hemodynamics","Ventilator Pressure and Optimization of Compliance and Hemodynamics: VPOCH Trial","VPOCH","Inclusion Criteria:\n\nPreterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \\\u003C 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.\n\n* Post-natal age \\> 7 days and less than 1 month (outside golden week protocol)\n* Gestational age ≥ 21 weeks and ≤ 34 week\n* Infants with written informed consent obtained from legal guardian\n\nExclusion Criteria:\n\n* Blood culture-positive sepsis\n* Congenital anomalies affecting respiration\n* Cyanotic or ductal-dependent congenital heart disease\n* Newborns who are considered too unstable for study enrolment per neonatology attending\n* Newborns on pressors or steroids for maintaining cardiac output\n* Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)\n* Open skin wounds or abrasions on the chest wall.","ALL","7 Days","30 Days",{"count":72,"type":73},24,"ESTIMATED","INTERVENTIONAL",[76],"NA","In preterm infants \\\u003C 34 weeks' gestation at birth receiving respiratory support with invasive positive pressure ventilation, the positive end-expiratory pressure (PEEP) of best compliance will increase the cardiac output and improve oxygenation. This study may emphasize using point-of-care echocardiography along with electrical impedance tomography (EIT) to optimize ventilator settings in preterm infants.\n\nInfants will be randomized to a 4-hour crossover period of increasing and decreasing PEEP in random order from baseline to determine compliance, oxygenation, and cardiac hemodynamics at each step using echocardiography (ECHO) and EIT measurements. There will be a 15-minute washout period after changes prior to data collection.",[79,80,81,82,83],"Bronchopulmonary Dysplasia","Pulmonary Hypertension Due to Lung Diseases and Hypoxia","Extreme Prematurity","Ventilator Lung; Newborn","Ventilation Perfusion Mismatch",[85,86,87],"Respiratory distress syndrome","ventilation mechanics in newborn","cardiac hemodynamics newborn","2026-05-06",{"date":90,"type":91},"2026-05-11","ACTUAL",{"date":93,"type":73},"2026-08-01",{"date":95,"type":73},"2027-06-30",{"name":5,"class":6},1]