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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05592431
Other study ID # MD 191/2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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