NCT06687083

Nasal High Frequency in Preterm Neonates

Non-Invasive High Frequency Oscillatory Ventilation Versus Continuous Positive Airway Pressure in Preterm Neonates with Respiratory Distress Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Not accepted

Summary

One of the most commonly used non-invasive methods is nasal continuous positive airway pressure (nCPAP). Although high frequency ventilation (HFV) has been applied in many neonatal intensive care units, nasal high frequency oscillatory ventilation (nHFOV) is a relatively new non-invasive modality. The application of nasal high-frequency ventilation with the strategy of lung recruitment will combine benefits of improving gas exchange and decreasing lung injury together with avoiding complication of invasive ventilation.

Detailed description

Premature infants with respiratory distress syndrome (RDS) usually require respiratory support . Due to the complications of intubation and mechanical ventilation, in the last decade, attempts have been made to use non-invasive methods in the management of these patients . Over the past few decades, nasal ventilation has been used to control and improve respiratory failure in infants with RDS . nCPAP is a relatively simple and effective therapy in the early management of RDS in newborns . nCPAP is the application of positive pressure to the airways of spontaneously breathing neonates throughout the respiratory cycle . However, some neonates with this therapeutic approach also develop respiratory failure and need mechanical ventilatory support. According to some investigations, 43%-80% of infants with moderate to severe respiratory failure who are initially treated with nCPAP need mechanical ventilation . In recent years, the beneficial effects of high-frequency ventilators (HFV) have been shown in the management of RDS as well as the use of this mode as the initial mode of support or as a rescue treatment after failure of conventional mechanical ventilation. In high-frequency ventilation, a low tidal volume with a higher frequency than that of physiological respiration is produced. This technique is very effective in eliminating carbon dioxide (CO2). Adequate recruitment of lung volume in this mechanical mode has the main role of protecting and preserving lung architecture as well as potentiating surfactant therapy. The nHFOV is a non-invasive ventilation mode that applies an oscillatory pressure waveform to the airways using a nasal interface. nHFOV is effective and superior to nasal intermittent positive pressure ventilation in terms of lung CO2 elimination. This mode has been shown to facilitate CO2 elimination, but little is known about its use in neonates. There is increasing evidence of beneficial effects of nHFOV in reducing the duration of ventilator support compared with the effects of nCPAP in RDS. We intended to explore the benefits of nHFOV vs nCPAP in preterm neonates.

Conditions

• Respiratory Distress Syndrome (RDS)
• Neonatal Diseases and Abnormalities

Interventions

Type	Name	Description
DEVICE	nasal high frequency oscillatory ventilation mode	Preterm neonates who will be allocated will start nHFOV: (CNO, Medin, Germany). nHFOV will be provided via binasal prongs (Size: small, medium, large; Diameter according to its chart; Medin, Germany). The initial parameters will be mean airway pressure (MAP) of 6 cm H2O (range 6-10), frequency of 8 Hz (range 8-12) and amplitude will be adjusted until infant's chest showed slight oscillations and amplitude will be 7 (range 7-10). The fraction of inspired oxygen (FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter.
DRUG	nasal continuous positive pressure ventilation mode	Preterm neonates who will be allocated to this group to the nCPAP will be started on a pressure of 6-8 cm H2O, FiO2) will be adjusted to maintain target oxygen saturation (SpO2) from 92% to 95% by a pulse oximeter

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-07-15
• Completion: 2023-07-15
• First posted: 2024-11-13
• Last updated: 2024-11-13

Locations

1 site across 1 country: Egypt