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

Respiratory Tract Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05592431
• Other study ID #: MD 191/2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: Mohamed Abdullah
• Phone: +201020144883
• Email: mohamedabdullah220692[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).
• 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

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Units (NICUs), Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of admission	To document total number of days of admission	8 weeks or till patient discharged
Secondary	Mortality rate	To document incidence of mortality during hospitalization	8 weeks or till patient death which comes first
Secondary	Incidence of feeding intolerance	Percentage of Patients who developed feeding intolerance	8 weeks or till patient discharged
Secondary	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
Secondary	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