An interventional study of Nasal humidified heated high flow cannula (NHHHC) and Nasal intermittent positive pressure ventilation (NIPPV) in Preterm and Ventilator Lung; Newborn, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 1 Hour to 24 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
This study aims to evaluate the effect of non-invasive ventilation (nIPPV)
, (nCPAP), and nasal high flow cannula (NHFC) as a primary mode of ventilation in preterm neonates \<37 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
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria: Preterm \<37 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).
Exclusion Criteria:
Device: Nasal intermittent positive pressure ventilation (NIPPV) · Device: lung ultrasound
Device: Nasal continuous positive airway pressure NCPAP · Device: lung ultrasound
Device: Nasal humidified heated high flow cannula (NHHHC) · Device: lung ultrasound
Patients in this arm will receive humidified heated high flow using Vapotherm device, USA. Stating with 2 L/min flow and increase gradually till 8L/minute, guided by oxygen requirements.
Patients in this arm will receive both PEEP (positive end expiratory pressure ) and PIP (peak inspiratory pressure) using SLE 5000/6000 device, UK . Pressures will be adjusted according to severity of respiratory distress.
Patients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar.
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).
Duration of non-Invasive ventilation (NIV)
Describe the days of non-invasive ventilation , described in days number.
Time frame: First two weeks of life.
Oxygen saturation index (OSI).
Mean airway pressure (MAP)X Fraction of inspired oxygen (FIO2) X SPO2 ( oxygen saturation) The score of OSI is recorded twice per day for first seven days.
Time frame: first one weeks of life.
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