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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nasal intermittent positive pressure ventilation group | Experimental |
| |
| nasal continuous positive pressure ventilation group | Experimental |
| |
| nasal high flow cannula group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal humidified heated high flow cannula (NHHHC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of non-Invasive ventilation (NIV) | Describe the days of non-invasive ventilation , described in days number. | First two weeks of life. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | first one weeks of life. |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa M Farag, PhD | Contact | 01288681788 | d.marwa.farag@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria university, Elshattbi hospital | Recruiting | Alexandria | 0354 | Egypt |
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| Nasal intermittent positive pressure ventilation (NIPPV) | Device | 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 | Device | Patients in this arm will receive PEEP (positive end expiratory pressure ), stating from 5 mbar to reach maximally 8 mbar. |
|
| lung ultrasound | Device | 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). |
|
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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