Evaluation of Nasal Non Invasive Ventilation in Management of Neonates With Respiratory Distress Using Lung Ultrasound
NCT ID: NCT06550219
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-11-20
2025-11-01
Brief Summary
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, (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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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nasal intermittent positive pressure ventilation group
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 5000/6000 device, UK . Pressures will be adjusted according to severity of respiratory distress.
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).
nasal continuous positive pressure ventilation group
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.
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).
nasal high flow cannula group
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/min flow and increase gradually till 8L/minute, guided by oxygen requirements.
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).
Interventions
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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/min flow and increase gradually till 8L/minute, guided by oxygen requirements.
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 5000/6000 device, UK . Pressures will be adjusted according to severity of respiratory distress.
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.
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).
Eligibility Criteria
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Exclusion Criteria
2. Any of the baby intubated for resuscitation or for other reasons.
3. Neonates need invasive mechanical ventilation.
4. Pulmonary hemorrhage.
5. Severe cardiovascular instability.
6. Cardiopulmonary arrest needing prolonged resuscitation.
7. Birth asphyxia (one-minute Apgar score ≤ 3).
8. Major cardiac diseases (not including patent ductus arteriosus).
1 Hour
24 Hours
ALL
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Marwa Mohamed Farag
Assistant professor
Locations
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Alexandria university, Elshattbi hospital
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0108428
Identifier Type: -
Identifier Source: org_study_id
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