Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates

Conditions
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Infant, Premature, Diseases, Respiratory Tract Diseases, Cerebral Blood Flow

Intervention / Treatment
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* Device: High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)
* Device: High Frequency Oscillatory Ventilation (SLE6000;SLE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm neonates with gestational age ≤ 35 weeks. 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: Preterm neonates with major upper or lower airway anomalies. Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )<br>After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements | Device: High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)<br>* ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P and high-frequency tidal volume (VThf).<br>* Other names: transcranial Doppler ultrasonographic examination;|
| Active Comparator: High Frequency Oscillatory Ventilation (HFOV)<br>After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements | Device: High Frequency Oscillatory Ventilation (SLE6000;SLE)<br>* ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P<br>* Other names: transcranial Doppler ultrasonographic examination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doppler cerebral blood flow velocity measurements | Investigate the effect of combining the VG mode with HFOV (HFOV-VG), versus the effect of HFOV alone, on Doppler cerebral blood flow velocity measurements | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficiency of HFOV-VG in comparison with HFOV alone | Evaluate the efficiency of HFOV-VG in comparison with HFOV alone as a rescue therapy in providing adequate neonatal ventilation and its possible impact on the short-term clinical outcome in terms of mortality and morbidities of these preterm neonates. | 8 weeks or till patient discharged | 
| Duration of admission | To document total number of days of admission | 8 weeks or till patient discharged | 
| Mortality rate | To document incidence of mortality during hospitalization | 8 weeks or till patient death which comes first | 
| Incidence of feeding intolerance | Percentage of Patients who developed feeding intolerance | 8 weeks or till patient discharged | 
| Days to reach full intake | Number of days needed by each patient to reach full intake | 8 weeks or till patient discharge which comes first | 
| Chest x ray change | Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree | Before intubation and and after 2 hours on assigned mode | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Frequency Oscillatory Ventilation, Volume Guarantee-High Frequency Oscillatory Ventilation, Preterm, Cerebral Blood Flow