Preterm, Ventilator Lung; Newborn
Conditions
Keywords
preterm infants, non-invasive ventilation
Brief summary
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
Interventions
DEVICENasal 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.
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.
DEVICENasal 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.
DEVICElung 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).
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 24 Hours
Healthy volunteers
Yes
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
1. Obvious major congenital abnormalities. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of non-Invasive ventilation (NIV) | First two weeks of life. | Describe the days of non-invasive ventilation , described in days number. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation index (OSI). | first one weeks of life. | 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. |
Countries
Egypt
Contacts
Primary ContactMarwa M Farag, PhD
Outcome results
None listed