Clinical trial NCT05592431: Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
Official title: Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Respiratory Tract Diseases
Cerebral Blood Flow
Keywords: High Frequency Oscillatory Ventilation
Volume Guarantee-High Frequency Oscillatory Ventilation
Preterm
Cerebral Blood Flow
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Preterm neonates with gestational age ≤ 35 weeks.
2. Neonates with various causes of respiratory failure: respiratory distress syndrome (RDS), air leak syndromes, pneumonia, or pulmonary hemorrhage, failing with conventional ventilation (i.e. when conventional ventilation failed to maintain either oxygenation or ventilation) and are switched to HFOV as a rescue therapy.

Exclusion Criteria:

1. Preterm neonates with major upper or lower airway anomalies.
2. Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory

Primary outcomes:
measure: Doppler cerebral blood flow velocity measurements
timeFrame: 72 hours
Secondary outcomes:
measure: efficiency of HFOV-VG in comparison with HFOV alone
timeFrame: 8 weeks or till patient discharged
measure: Duration of admission
timeFrame: 8 weeks or till patient discharged
measure: Mortality rate
timeFrame: 8 weeks or till patient death which comes first
measure: Incidence of feeding intolerance
timeFrame: 8 weeks or till patient discharged
measure: Days to reach full intake
timeFrame: 8 weeks or till patient discharge which comes first
measure: Chest x ray change
timeFrame: Before intubation and and after 2 hours on assigned mode
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Neonatal Intensive Care Units (NICUs), Ain Shams University
state: Abbasia
Study officials:
References: