[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tina Slusher\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100569723","feasibility-of-using-the-neovent-in-low-resource-settings-100569723",false,"NCT06697951","Feasibility of Using the Neovent in Low-Resource Settings","Feasibility of Using Bubble Nasal Intermittent Pressure Ventilation Using the Neovent in Low-resource Settings","Neovent","Inclusion Criteria:\n\n* Infants ≤ 28 days and \\> 30weeks and\u002For \\> 1000 gram (birthweight or admission weight if birthweight unknown)\n* Mild to moderate respiratory distress (Downes' score 2 - 7)\n* Parental\u002Fguardian permission (informed consent).\n\nExclusion Criteria:\n\n* Congenital abnormality such that noninvasive positive pressure ventilation would be contraindicated (e.g. diaphragmatic hernia, cleft palate, tracheo-esophageal fistula)\n* Need for immediate surgical intervention\n* Suspected neuromuscular abnormality as evidenced by decreased tone\n* Suspected cyanotic congenital cardiac disease or cardiac instability\n* Severe life-threatening condition such that the doctor caring for the patient believes survival of patient will be less than 24 hours and\u002For parents request withdrawal of care","ALL","1 Minute","28 Days",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","Breathing problems are a leading cause of newborn death\u002Fsickness worldwide but most of deaths are in low resources areas. Over 99% of newborn death is in countries with limited healthcare resources like Nigeria and Nepal.\n\nBackground For newborns who have trouble breathing, breathing with a machine that does not require an invasive breathing tube but only small nasal tubes is associated with lower rates of lung disease and less pneumonia or lung disease than newborns who have a breathing tube going into their lungs to help their breathing. Nasal Intermittent Positive Pressure Ventilation (NIPPV) is often used in high resource countries, but these machines are expensive. NIPPV gives many newborns the extra support needed to help with trouble breathing by providing extra pressure to help more air\u002Foxygen get into their lungs. Neovent was designed to provide NIPPV at a much lower cost than machines than conventional machines. The Neovent has been shown to be safe and the device feasible in a higher resourced nursery than found in most nurseries in Nigeria and Nepal.\n\nThe primary and critical research gap this study will address is to show that investigators in lower resourced nurseries can use the Neovent thus demonstrating that this device is feasible to provide NIPPV for newborns with breathing problems without any more safety problems that those seen with the continuous positive airway pressure currently used in lower resourced nurseries in Nigeria and Nepal.\n\nAims The investigators believe NIPPV using the Neovent is feasible for use by healthcare providers in lower resourced nurseries in Nepal and Nigeria; that NIPPV provided by Neovent will be as safe as breathing support providing by machine CPAP and newborns on Neovent will not have more nasal irritation or nose bleeds, more stomach problems, or air around their lungs than newborns on machine CPAP.\n\nStudy design Newborns with mild-moderate breathing trouble whose mother\u002Fcaregivers agrees will be placed on Neovent for 6 hours and monitored closely for any problems with the machine or newborn that are related to the machine especially injury to the nose, nosebleeds, swollen belly or abdomen, or air around the lungs.\n\nSample size We plan to enroll 70 newborn infants total from both sites in Nepal and Nigeria.\n\nNext Steps The next step would be to do a study to determine if the Neovent is as good as other more expensive forms of breathing support for newborn infants.",[28],"Respiratory Distress of Newborn",[30,31,32,33,34,35,36],"newborn","neonate","respiratory distress","Bilevel ventilation","low resource","Nepal","Nigeria","RECRUITING","2025-06-04",{"date":40,"type":41},"2025-06-08","ACTUAL",{"date":43,"type":41},"2025-03-10",{"date":45,"type":22},"2025-12-31",{"name":47,"class":48},"Tina Slusher","OTHER",2,""]