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Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates
A randomized controlled clinical trial evaluates cerebral blood flow changes associated with HFOV-VG in comparison to HFOV alone in preterm neonates with respiratory insufficiency during the period of invasive respiratory support
Neonatal respiratory distress (NRD) is one of the most common problems in the first few days of neonatal life. NRD has been reported to be prevalent in 5 - 29% of the NICU hospitalized neonates. High-frequency oscillatory ventilation (HFOV) has been used for more than three decades, it is a rescue maneuver for failed conventional mechanical ventilation. It delivers small tidal volumes to improve gas exchange. As it uses a low tidal volume, under the anatomical dead space at supra-physiological respiratory frequencies HFOV can reduce the risk of lung injury related to the ventilator and consequently reduce the risk of bronchopulmonary dysplasia HFOV is indicated for patients with neonatal air leak syndrome, persistent pulmonary hypertension, and meconium aspiration Several factors are known to influence cerebral perfusion during HFOV. Hypercapnia increases cerebral blood flow (CBF) while a reduction in PaCO2 leads to cerebral vasoconstriction and decreases CBF, Hypoxia is also known to increase CBF via cerebral vasodilation HFOV with volume guarantee (HFOV-VG) is a promising new ventilator mode for the treatment of respiratory failure in newborns. HFOV-VG is expected to result in less lung injury since it reduces fluctuations of high frequency tidal volume (VThf), reduces the number of out-of-target pCO2 values and provides fewer hypoxia attacks compared with HFOV alone
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, Egypt
Start Date
October 27, 2022
Primary Completion Date
May 30, 2024
Completion Date
August 30, 2024
Last Updated
September 25, 2024
60
ACTUAL participants
High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)
DEVICE
High Frequency Oscillatory Ventilation (SLE6000;SLE)
DEVICE
Lead Sponsor
Ain Shams University
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06878742