[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563956":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":22,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":22,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":22,"maxAge":22,"enrollmentInfo":61,"targetDuration":22,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":35,"whyStopped":22,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Rambam Health Care Campus","OTHER",[8,14],{"label":9,"type":10,"description":9,"interventionNames":11},"start with 2LPM","EXPERIMENTAL",[12,13],"Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours","Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3h",{"label":15,"type":10,"description":16,"interventionNames":17},"start with 6LPM0","start with 6LPM",[12,13],[19,23],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":22},"change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours",[9,15],null,{"type":6,"name":24,"description":24,"armGroupLabels":25,"otherNames":22},"change flow from 2 to 6 LPM. Follow TcCO2 for 3h",[9,15],[27],{"name":28,"role":29,"phone":30,"phoneExt":22,"email":31},"Ori Hochwald, MD","CONTACT","972502062110","ORI.HOCHWALD@GMAIL.COM",[33],{"facility":34,"status":35,"city":36,"state":22,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rambam Medical Center","RECRUITING","Haifa","31096","Israel","IL",{"type":41,"coordinates":42},"Point",[43,44],34.99928,32.81303,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":48,"phoneExt":22,"email":49},"972-4-7774111","o_hochwald@rambam.health.gov.il",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Ori Hochwald , MD","Head, NICU","100563956","influence-of-flow-rate-change-on-co2-levels-during-high-flow-nasal-ventilation-hfnv-in-preterm-infants-100563956",false,"NCT06622902","Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.","Inclusion criteria:\n\n* Gestational age 240 to 336.\n* At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).\n* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.\n* At least 6 hours from surfactant administration.\n* Parental consent\n\nExclusion criteria:\n\n* If flow is \\&lt;3 and tcCO2 related pCO2 is\\&lt;40mmHg.\n* If Flow is ≥5 bpm and tcCO2 related pCO2 is\\&gt;60mmHg.\n* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.","ALL",{"count":62,"type":63},45,"ESTIMATED","INTERVENTIONAL",[66],"NA","Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding.\n\nAim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants.\n\nMethods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours.\n\nOutcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics.\n\nStatistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.",[69,70,71],"Respiratory Distress Syndrome","Prematurity","Non Invasive Ventilation",[73,74,75,76,77],"Respiratory distress syndrome","prematurity","HIGH FLOW","CO2","VENTILATION","2025-11-26",{"date":80,"type":81},"2025-11-28","ACTUAL",{"date":83,"type":81},"2023-08-16",{"date":85,"type":63},"2026-12-31",{"name":5,"class":6},1]