[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558369":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":11,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Alexandria University","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"nasal intermittent positive pressure ventilation group","EXPERIMENTAL",null,[13,14],"Device: Nasal intermittent positive pressure ventilation (NIPPV)","Device: lung ultrasound",{"label":16,"type":10,"description":11,"interventionNames":17},"nasal continuous positive pressure ventilation group",[18,14],"Device: Nasal continuous positive airway pressure NCPAP",{"label":20,"type":10,"description":11,"interventionNames":21},"nasal high flow cannula group",[22,14],"Device: Nasal humidified heated high flow cannula (NHHHC)",[24,29,33,37],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DEVICE","Nasal humidified heated high flow cannula (NHHHC)","Patients in this arm will receive humidified heated high flow using Vapotherm device, USA. Stating with 2 L\u002Fmin flow and increase gradually till 8L\u002Fminute, guided by oxygen requirements.",[20],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"Nasal intermittent positive pressure ventilation (NIPPV)","Patients in this arm will receive both PEEP (positive end expiratory pressure ) and PIP (peak inspiratory pressure) using SLE 5000\u002F6000 device, UK . Pressures will be adjusted according to severity of respiratory distress.",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Nasal continuous positive airway pressure NCPAP","Patients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar.",[16],{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"lung ultrasound","Lung ultrasound (LUS) machine is a mobile device (Philips HDll XE, USA) with s8-3 probe with a frequency range of 8-3 MHz will be used as ultrasound machine. Throughout the period of non-invasive respiratory support Patient will be monitored by: LUS,Heart rate, Respiratory rate, Mean arterial pressure, Oxygen saturation index, Oxygen index, PaO2, blood gases and Fractional inspired oxygen (Fio2).",[16,20,9],[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Marwa M Farag, PhD","CONTACT","01288681788","d.marwa.farag@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":11,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Alexandria university, Elshattbi hospital","RECRUITING","Alexandria","0354","Egypt","EG",{"type":56,"coordinates":57},"Point",[58,59],29.91582,31.20176,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":45,"phoneExt":64,"email":46},"Marwa Mohamed Farag, phD","+2",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Marwa Mohamed Farag","Assistant professor","100558369","evaluation-of-nasal-non-invasive-ventilation-in-management-of-neonates-with-respiratory-distress-using-lung-ultrasound-100558369",false,"NCT06550219","Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound","Evaluation of Nasal Non Invasive Ventilation Modalities in Management of Neonates With Respiratory Distress Using Lung Ultrasound","Inclusion Criteria: Preterm \\\u003C37 wk. gestational age admitted to the NICU with spontaneous breathing and clinical manifestations of RD (tachypnea, nasal flaring, intercostal and subcostal retraction and or grunting).\n\nExclusion Criteria:\n\n1. Obvious major congenital abnormalities.\n2. Any of the baby intubated for resuscitation or for other reasons.\n3. Neonates need invasive mechanical ventilation.\n4. Pulmonary hemorrhage.\n5. Severe cardiovascular instability.\n6. Cardiopulmonary arrest needing prolonged resuscitation.\n7. Birth asphyxia (one-minute Apgar score ≤ 3).\n8. Major cardiac diseases (not including patent ductus arteriosus).",true,"ALL","1 Hour","24 Hours",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study aims to evaluate the effect of non-invasive ventilation (nIPPV)\n\n, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates \\\u003C37 gestational week with moderate to severe RD using LUS as regard: I. Primary outcomes: Duration of non-Invasive ventilation. II. Secondary outcomes: Evaluation LUS over the 1 st 7 days of life or weaning from ventilation. Need for intubation and invasive ventilation. Duration of respiratory support. Need for surfactant. Oxygen saturation index and oxygen index. Broncho-pulmonary dysplasia; grade. Duration of hospital stay",[88,89],"Preterm","Ventilator Lung; Newborn",[91,92],"preterm infants","non-invasive ventilation","2025-02-03",{"date":95,"type":96},"2025-02-04","ACTUAL",{"date":98,"type":96},"2024-11-20",{"date":100,"type":82},"2025-11-01",{"name":5,"class":6},1]