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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)
High Frequency Oscillatory Ventilation (SLE6000;SLE)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infant, Premature, Diseases focused on measuring High Frequency Oscillatory Ventilation, Volume Guarantee-High Frequency Oscillatory Ventilation, Preterm, Cerebral Blood Flow

Eligibility Criteria

1 Day - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neonatal Intensive Care Units (NICUs), Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )

High Frequency Oscillatory Ventilation (HFOV)

Arm Description

After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements

After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Duration of admission
To document total number of days of admission
Mortality rate
To document incidence of mortality during hospitalization
Incidence of feeding intolerance
Percentage of Patients who developed feeding intolerance
Days to reach full intake
Number of days needed by each patient to reach full intake
Chest x ray change
Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree

Full Information

First Posted
October 20, 2022
Last Updated
October 20, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05592431
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 27, 2022 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Respiratory Tract Diseases, Cerebral Blood Flow
Keywords
High Frequency Oscillatory Ventilation, Volume Guarantee-High Frequency Oscillatory Ventilation, Preterm, Cerebral Blood Flow

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG )
Arm Type
Experimental
Arm Description
After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements
Arm Title
High Frequency Oscillatory Ventilation (HFOV)
Arm Type
Active Comparator
Arm Description
After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements
Intervention Type
Device
Intervention Name(s)
High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)
Other Intervention Name(s)
transcranial Doppler ultrasonographic examination
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
High Frequency Oscillatory Ventilation (SLE6000;SLE)
Other Intervention Name(s)
transcranial Doppler ultrasonographic examination
Intervention Description
ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P
Primary Outcome Measure Information:
Title
Doppler cerebral blood flow velocity measurements
Description
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
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
efficiency of HFOV-VG in comparison with HFOV alone
Description
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.
Time Frame
8 weeks or till patient discharged
Title
Duration of admission
Description
To document total number of days of admission
Time Frame
8 weeks or till patient discharged
Title
Mortality rate
Description
To document incidence of mortality during hospitalization
Time Frame
8 weeks or till patient death which comes first
Title
Incidence of feeding intolerance
Description
Percentage of Patients who developed feeding intolerance
Time Frame
8 weeks or till patient discharged
Title
Days to reach full intake
Description
Number of days needed by each patient to reach full intake
Time Frame
8 weeks or till patient discharge which comes first
Title
Chest x ray change
Description
Chest x ray grading of RDS performed to patient before and after the assigned mode to compare lung aeration degree
Time Frame
Before intubation and and after 2 hours on assigned mode

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdullah
Phone
+201020144883
Ext
202
Email
mohamedabdullah220692@gmail.com
Facility Information:
Facility Name
Neonatal Intensive Care Units (NICUs), Ain Shams University
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11517
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdullah
Phone
01020144883
Ext
202
Email
mohamed.abdullah@med.asu.edu.eg

12. IPD Sharing Statement

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

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