Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 1, 2021

Primary Completion Date

September 1, 2023

Study Completion Date

September 1, 2023

Conditions
Ventilation
Interventions
DEVICE

Nasal high frequency oscillatory ventilation

NHFOV was administered using the SLE 6000 device manufactured by Wipro GE Healthcare Private Limited in Bengaluru, Karnataka. The initial amplitude was set at 25 cm H2O and adjusted to a maximum of 35 cm H2O based on clinical response. The frequency was set at 12 Hz. The mean airway pressure (MAP) was initiated at 6 cmH2O and titrated up to 10 cmH2O based on clinical assessment. The I:E ratio was maintained between 1:1 to 1:2 in cases of air trapping, using nasal prongs •

DEVICE

Vapotherm Group

The Hi-VNI Vapotherm was administered using the Vapotherm device, manufactured by Vapotherm, INC, USA. Initially, the flow rate was set at 4 L/min and adjusted accordingly to achieve the desired clinical outcome, with a maximum flow rate of 8 L/min when necessary. The temperature was maintained at 36-37°C, and the FiO2 was adjusted as required to attain the target SpO2 range of 90% to 94%، using soft nasal cannula interface

DEVICE

Nasal CPAP Group

CPAP therapy was administered using the MEDIN CNO device, developed by medin Medical Innovations GmbH in Olching, Germany. The initial pressure was set at 5 cmH2O and adjusted accordingly to achieve the desired clinical outcome, with a maximum pressure of 8 cmH2O. This approach aimed to maintain the target oxygen saturation (SpO2) levels between 90% and 94%، using bi-nasal with midline prongs

Trial Locations (1)

Unknown

Ainshams university, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER

NCT06737003 - Haemodynamic Changes With Different Noninvasive Respiratory Modes for Primary Respiratory Support in Preterm Neonates | Biotech Hunter | Biotech Hunter