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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Tract Diseases; Cerebral Blood Flow; Infant, Premature, Diseases
• Intervention / Treatment: Device: High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE); Device: High Frequency Oscillatory Ventilation (SLE6000;SLE)

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Abdullah; Phone Number: 202 +201020144883; Email: mohamedabdullah220692@gmail.com

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11517
      • Neonatal Intensive Care Units (NICUs), Ain Shams University
      • Contact: Mohamed Abdullah; Phone Number: 202 01020144883; Email: mohamed.abdullah@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG ); 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); 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).; Other Names: transcranial Doppler ultrasonographic examination
Active Comparator: High Frequency Oscillatory Ventilation (HFOV); 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); ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P; Other Names: transcranial Doppler ultrasonographic examination

What is the study measuring?

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
Mortality rate	To document incidence of mortality during hospitalization	8 weeks or till patient death which comes first
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
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
Incidence of feeding intolerance	Percentage of Patients who developed feeding intolerance	8 weeks or till patient discharged
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 27, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Preterm; Cerebral Blood Flow; High Frequency Oscillatory Ventilation; Volume Guarantee-High Frequency Oscillatory Ventilation
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Tract Diseases
• Other Study ID Numbers: MD 191/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No