[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04774848":3,"trial-entities:NCT04774848":109,"trial-summary:NCT04774848":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":47,"sex":59,"minimum_age":17,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":65,"locations":67,"central_contacts":101,"overall_officials":105,"references":107,"see_also_links":108},"NCT04774848","133683","High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia","High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation as Initial Mode of Ventilation for Congenital Diaphragmatic Hernia","RECRUITING","2025-08-28","2025-01","2025-04-04","2020-12-30","University of Utah","OTHER",false,"The purpose of this study is to conduct a prospective study of all congenital diaphragmatic hernia (CDH) neonates managed at the University of Utah newborn intensive care unit (NICU) and Primary Children's Hospital NICU that required mechanical ventilation at birth. As both high frequency jet ventilation (HFJV) and high frequency oscillatory ventilation (HFOV) are standard approaches to ventilatory support of all neonates including CDH, CDH infants will be randomized at the time of birth or admission to either HFJV or HFOV as initial ventilator mode, stratified by position of the liver in the abdomen or thorax (if known) by 24 hours of age. Measures of oxygenation, ventilation and hemodynamics of the CDH cohort managed on HFOV compared to those on HFJV.",null,[19],"Congenital Diaphragmatic Hernia",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},50,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","High Frequency Jet Ventilator","HFJV provides short bursts of gas into the respiratory circuit at a rate of 240 to 600\u002Fmin (4 to 11 Hz) and expiration is passive. It is used in conjunction with a conventional ventilator which provides positive end expiratory pressure (PEEP) and can also provide occasional sigh breaths.",[34,35],"High Frequency Jet Ventilation (HFJV) with intrathoracic liver","High Frequency Jet Ventilation (HFJV) without intrathoracic liver",{"type":30,"name":37,"description":38,"armGroupLabels":39},"High Frequency Oscillatory Ventilator","HFOV uses a piston diaphragm to generate alternating positive and negative pressure changes to give breaths of 300 to 900\u002Fmin (5-15 Hz) given over a set mean airway pressure. Both inhalation and exhalation are active.",[40,41],"High Frequency Oscillatory Ventilation (HFOV) with intrathoracic liver","High Frequency Oscillatory Ventilation (HFOV) without intrathoracic liver",[43],{"measure":44,"description":45,"timeFrame":46},"Oxygenation Index (OI) at 24 hours of age","The OI will be measured at 24 hours of age using a standard of care arterial blood gas and oxygen settings. These measurements will then be compared between the stratified groups","24 hours of age",[48,52,54,56],{"measure":49,"description":50,"timeFrame":51},"PF ratio (PaO2\u002FFiO2) measurements","These measurements will be determined at multiple time points for the first week of life. These measurements will be compared between groups.","up to one week",{"measure":53,"description":50,"timeFrame":51},"PF-PCO2 (PaO2\u002FFiO2-PaCO2) measurements",{"measure":55,"description":50,"timeFrame":51},"PaCO2 measurements",{"measure":57,"description":58,"timeFrame":51},"Number of babies who received inhaled nitric oxide (iNO)","the number of babies who received treatment of iNO will be compared amongst the different groups","ALL","24 Hours",{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Admitted to either the University of Utah and\u002For Primary Children's Hospital NICU within 24 hours of birth\n2. Requiring mechanical ventilation\n3. Umbilical arterial line or peripheral arterial line in place\n4. Obtained signed consent\n5. Infant is ≤ 24 hours of age\n\nExclusion Criteria:\n\n1. Severe anomaly\n\n   1. Chromosomal abnormalities\n   2. Major congenital anomalies, including cardiac, central nervous system and syndromes\n2. Post-natal diagnosis \\> 24 hours of life\n3. Unable to obtain consent for participation\n4. Unable to randomize within 24 hours of life",[66],"CHILD",[68,89],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":86},"Primary Children's Hospital","Salt Lake City","Utah","84113","United States",[75,80,84],{"name":76,"role":77,"phone":78,"email":79},"Michelle Yang, MD","CONTACT","801-581-7052","michelle.yang@hsc.utah.edu",{"name":81,"role":77,"phone":82,"email":83},"Kimberlee Weaver-Lewis, RN","801-507-7675","kimberlee.weaverlewis@imail.org",{"name":76,"role":85},"PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},40.76078,-111.89105,{"facility":90,"status":8,"city":70,"state":71,"zip":91,"country":73,"contacts":92,"geoPoint":100},"University Hospital","84132",[93,95,99],{"name":76,"role":77,"phone":78,"email":94},"michell.yang@hsc.utah.edu",{"name":96,"role":77,"phone":97,"email":98},"Carrie Rau, RN","801-213-3360","carrie.rau@hsc.utah.edu",{"name":76,"role":85},{"lat":87,"lon":88},[102,103],{"name":76,"role":77,"phone":78,"email":79},{"name":104,"role":77,"phone":97,"email":98},"Carrie Rau",[106],{"name":76,"affiliation":13,"role":85},[],[],{"nct_id":4,"conditions":110,"biomarkers":111},[19],[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This study is an interventional study that will randomize 50 participants to receive either High Frequency Jet Ventilation or High Frequency Oscillatory Ventilation.","completed","High Frequency Ventilation for Congenital Diaphragmatic Hernia","This study is looking at two different ways to help babies with congenital diaphragmatic hernia (CDH) breathe: High Frequency Jet Ventilation (HFJV) and High Frequency Oscillatory Ventilation (HFOV). Both are standard methods used in the NICU (Neonatal Intensive Care Unit). Researchers want to see which method works better for these babies by comparing how well their oxygen levels are at 24 hours of age. Babies who are 24 hours old or less, need a breathing machine, and have an arterial line can join. You cannot participate if your baby has severe chromosomal abnormalities. The study plans to include 50 babies, but the current recruitment status is unclear.","The primary endpoint, Oxygenation Index, is measured at 24 hours of age.",107,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]