[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07674953":3,"trial-entities:NCT07674953":131,"trial-summary:NCT07674953":135},{"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":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":42,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":64,"locations":68,"central_contacts":95,"overall_officials":97,"references":98,"see_also_links":130},"NCT07674953","299138","How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants","Oxygen Delivery in CPAP and Its Relationship With Regional Lung Ventilation in Preterm Infants","RECRUITING","2027-06","2026-06","2026-06-30","2026-04-15","University of Arkansas","OTHER",false,"With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.","This study will tell more about a specific method of breathing support used frequently with preterm babies called nasal continuous positive airway pressure (nCPAP). It helps the baby breathe by providing air pressure and a certain amount of oxygen. It is very important for the baby's health to provide only as much oxygen as they need.\n\nWith this study, it is expected to learn if the amount of oxygen ordered by a doctor on the nCPAP machine changes when it reaches the baby's airway, and if the amount of oxygen changes depending on how much air pressure the doctor provides. The answers to these questions, are not known, because special measurements are required that are difficult to know while a baby is on nCPAP. This study will collect these special measurements",[19,20],"Respiratory Distress Syndrome (Neonatal)","Respiratory Distress of Newborn",[22,23,24,25],"respiratory distress syndrome","CPAP","preterm infant","effective oxygen delivery","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},10,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"DEVICE","Effective oxygen delivery and lung expansion measurement","This intervention arm will involve any infant who is already on nCPAP. It will involve placing a catheter in the infant's oropharynx and wrapping soft EIT bands around the infants chest to measure effective oxygen delivery and lung expansion, respectively.",[39],"Infants on nCPAP",[41],"EIT",[43],{"measure":44,"description":45,"timeFrame":46},"Inspired Oxygen","Percent of oxygen delivered to the back of the infant's mouth. This will be measured by placing a small plastic tube in the back of the infant's mouth and sampling the air while the infant is receiving several different pressure levels of CPAP.","Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.",[48],{"measure":49,"description":50,"timeFrame":51},"Lung Volume","Using Electrical Impedance Tomography bands, the infant's lung volume will be monitored at several different CPAP pressure levels. These bands wrap around the infant's chest and measure lung volume using mild electrical currents.","Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.","ALL",null,{"inclusion":55,"exclusion":59,"raw_text":63},[56,57,58],"Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical","The infant must be stable while receiving nasal CPAP at any pressure level at the time of study","The infant must be receiving 22-40% at the time of the study",[60,61,62],"Oxygen requirements greater than 40% at time of enrollment","currently receiving invasive ventilation or not requiring ventilatory support","Major congenital anomalies of the heart and\u002For lungs","Inclusion Criteria:\n\n* Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical\n* The infant must be stable while receiving nasal CPAP at any pressure level at the time of study\n* The infant must be receiving 22-40% at the time of the study\n\nExclusion Criteria:\n\n* Oxygen requirements greater than 40% at time of enrollment\n* currently receiving invasive ventilation or not requiring ventilatory support\n* Major congenital anomalies of the heart and\u002For lungs",[65,66,67],"CHILD","ADULT","OLDER_ADULT",[69,85],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"University of Arkansas for Medical Sciences","NOT_YET_RECRUITING","Little Rock","Arkansas","72205","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Nicholas A Rowley, MD","CONTACT","940-230-5002","NARowley@uams.edu",{"lat":83,"lon":84},34.74648,-92.28959,{"facility":70,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":86,"geoPoint":94},[87,91],{"name":88,"role":79,"phone":89,"email":90},"Sherry Courtney Research Mentor, MD","501-526-1500","SECourtney@uams.edu",{"name":92,"role":93},"Nicholas Rowley, MD","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},[96],{"name":78,"role":79,"phone":80,"email":81},[],[99,103,106,109,112,115,118,121,124,127],{"pmid":100,"type":101,"citation":102},"33246967","BACKGROUND","Thomson J, Ruegger CM, Perkins EJ, Pereira-Fantini PM, Farrell O, Owen LS, Tingay DG. Regional ventilation characteristics during non-invasive respiratory support in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):370-375. doi: 10.1136\u002Farchdischild-2020-320449. Epub 2020 Nov 27.",{"pmid":104,"type":101,"citation":105},"10654946","Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542\u002Fpeds.105.2.295.",{"pmid":107,"type":101,"citation":108},"32762014","Ramaswamy VV, More K, Roehr CC, Bandiya P, Nangia S. Efficacy of noninvasive respiratory support modes for primary respiratory support in preterm neonates with respiratory distress syndrome: Systematic review and network meta-analysis. Pediatr Pulmonol. 2020 Nov;55(11):2940-2963. doi: 10.1002\u002Fppul.25011. Epub 2020 Sep 4.",{"pmid":110,"type":101,"citation":111},"26948884","Gupta S, Donn SM. Continuous positive airway pressure: Physiology and comparison of devices. Semin Fetal Neonatal Med. 2016 Jun;21(3):204-11. doi: 10.1016\u002Fj.siny.2016.02.009. Epub 2016 Mar 3.",{"pmid":113,"type":101,"citation":114},"27596161","Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136\u002Fthoraxjnl-2016-208357. Epub 2016 Sep 5.",{"pmid":116,"type":101,"citation":117},"34830385","Cannavo L, Perrone S, Viola V, Marseglia L, Di Rosa G, Gitto E. Oxidative Stress and Respiratory Diseases in Preterm Newborns. Int J Mol Sci. 2021 Nov 19;22(22):12504. doi: 10.3390\u002Fijms222212504.",{"pmid":119,"type":101,"citation":120},"28545875","Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016\u002Fj.jpeds.2017.04.046. Epub 2017 May 22.",{"pmid":122,"type":101,"citation":123},"34162692","Bhatia R, Carlisle HR, Armstrong RK, Kamlin COF, Davis PG, Tingay DG. Extubation generates lung volume inhomogeneity in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):82-86. doi: 10.1136\u002Farchdischild-2021-321788. Epub 2021 Jun 23.",{"pmid":125,"type":101,"citation":126},"8130865","Benaron DA, Benitz WE. Maximizing the stability of oxygen delivered via nasal cannula. Arch Pediatr Adolesc Med. 1994 Mar;148(3):294-300. doi: 10.1001\u002Farchpedi.1994.02170030064015.",{"pmid":128,"type":101,"citation":129},"19491438","Adler A, Arnold JH, Bayford R, Borsic A, Brown B, Dixon P, Faes TJ, Frerichs I, Gagnon H, Garber Y, Grychtol B, Hahn G, Lionheart WR, Malik A, Patterson RP, Stocks J, Tizzard A, Weiler N, Wolf GK. GREIT: a unified approach to 2D linear EIT reconstruction of lung images. Physiol Meas. 2009 Jun;30(6):S35-55. doi: 10.1088\u002F0967-3334\u002F30\u002F6\u002FS03. Epub 2009 Jun 2.",[],{"nct_id":4,"conditions":132,"biomarkers":134},[133],"Respiratory Distress Syndrome",[],{"nct_id":4,"found":136,"summary":137,"prompt_version":147},true,{"design":138,"status":139,"heading":140,"summary":141,"follow_up":142,"word_count":143,"commitments":144,"compensation":145,"drugs_mentioned":146},"This interventional study will involve 10 preterm infants. It is not specified if the study is randomized or blinded.","completed","Understanding Oxygen Delivery in Preterm Infants on CPAP","This study aims to understand how different levels of breathing support, called nasal continuous positive airway pressure (nCPAP), affect how much oxygen preterm babies actually receive and how well their lungs expand. Researchers will measure oxygen delivery and lung expansion using a catheter in the baby's throat and soft bands around their chest. The goal is to learn if the oxygen amount ordered by a doctor on the nCPAP machine changes by the time it reaches the baby's airway, and if this changes with different air pressure settings. This study is for preterm infants born before 35 weeks who are stable on nCPAP and receiving 22-40% oxygen. There are 10 planned participants.","Not specified.",112,"You would need to allow for a catheter to be placed in your infant's throat and soft bands to be wrapped around their chest. Measurements will occur at three separate points within a thirty-minute timeframe.","Not stated in the trial record.",[],"v2"]