NCT05706428

Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

Cardiorespiratory Effects of Nasal High Frequency Ventilation in Moderate and Late Preterm Infants With Respiratory Distress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 1 Hour – 3 Days
• Healthy volunteers: Not accepted

Summary

The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard: I. Primary outcomes: * Duration of the non- invasive respiratory support. * Need of invasive ventilation in the first 72 hours. * Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma. II. Secondary outcomes: * Need for surfactant administration. * Days on invasive mechanical ventilation. * Days on supplemental oxygen. * Duration of hospital stay. * Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.

Conditions

• Ventilator Lung; Newborn
• Hemodynamic Instability
• Echocardiography

Interventions

Type	Name	Description
DEVICE	NHFOV	The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.
DEVICE	NCPAP	The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-09-28
• Completion: 2023-10-13
• First posted: 2023-01-31
• Last updated: 2023-11-07

Locations

1 site across 1 country: Egypt