Infant, Premature, DiseasesNCT05592431
Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Neonates
A study testing High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE) and High Frequency Oscillatory Ventilation (SLE6000;SLE) in people with Infant, Premature, Diseases and Respiratory Tract Diseases, run by Ain Shams University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Infant, Premature, Diseases, Respiratory Tract Diseases, Cerebral Blood Flow
- What is being tested?
- High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE) and High Frequency Oscillatory Ventilation (SLE6000;SLE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Oct 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Preterm neonates with major upper or lower airway anomalies.
- Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, 11517
About this study
Official title: 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
Read the 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
- Being tested
- High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE), High Frequency Oscillatory Ventilation (SLE6000;SLE)
- Keywords
- High Frequency Oscillatory Ventilation, Volume Guarantee-High Frequency Oscillatory Ventilation, Preterm, Cerebral Blood Flow
- Medical subject headings
- Infant, Premature, Diseases, Respiratory Tract Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)Device
Also called transcranial Doppler ultrasonographic examination
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)Device
Also called transcranial Doppler ultrasonographic examination
ventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P
| Study group | Role | What they receive |
|---|---|---|
| High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG ) | Experimental | After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements Receives: Device: High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE) |
| High Frequency Oscillatory Ventilation (HFOV) | Active comparator | After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements Receives: Device: High Frequency Oscillatory Ventilation (SLE6000;SLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (6)
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.
Measured: 8 weeks or till patient discharged
Duration of admission
To document total number of days of admission
Measured: 8 weeks or till patient discharged
Mortality rate
To document incidence of mortality during hospitalization
Measured: 8 weeks or till patient death which comes first
Incidence of feeding intolerance
Percentage of Patients who developed feeding intolerance
Measured: 8 weeks or till patient discharged
Days to reach full intake
Number of days needed by each patient to reach full intake
Measured: 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
Measured: Before intubation and and after 2 hours on assigned mode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start27 Oct 2022
- Primary completion30 May 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdullah Moussa Akid, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592431
- Sponsor's protocol ID
- MD 191/2022
- Status last verified
- Sep 2024
- First submitted
- 20 Oct 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Volume Guarantee-High Frequency Oscillatory Ventilation on Cerebral Blood Flow in Preterm Neonates
- ClinicalTrials.gov ID
- NCT05592431
- Acronym / sponsor ID
- MD 191/2022
- Keywords
- High Frequency Oscillatory Ventilation, Volume Guarantee-High Frequency Oscillatory Ventilation, Preterm, Cerebral Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG ) | Experimental | Device: High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV-VG ) will be assessed by doppler cerebral blood flow velocity measurements |
| High Frequency Oscillatory Ventilation (HFOV) | Active comparator | Device: High Frequency Oscillatory Ventilation (SLE6000;SLE)After documenting parental consent, preterm neonates with respiratory insufficiency randomly ventilated on (HFOV) will be assessed by doppler cerebral blood flow velocity measurements |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Preterm neonates with major upper or lower airway anomalies.
- Preterm neonates with significant congenital anomalies including cardiac, abdominal or respiratory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE)Also: transcranial Doppler ultrasonographic examinationventilator 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). | Device | High Frequency Oscillatory Ventilation with Volume Guarantee (HFOV-VG ) |
| High Frequency Oscillatory Ventilation (SLE6000;SLE)Also: transcranial Doppler ultrasonographic examinationventilator settings will be recorded such as: inspiratory: expiratory ratio (I:E), fractionated inspired oxygen (FiO2), mean airway pressure (MAP), frequency (HZ), delta P | Device | High Frequency Oscillatory Ventilation (HFOV) |
Primary outcome
Doppler cerebral blood flow velocity measurements
Time frame: 72 hours
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
6 secondary outcomes
efficiency of HFOV-VG in comparison with HFOV alone
Time frame: 8 weeks or till patient discharged
Duration of admission
Time frame: 8 weeks or till patient discharged
Mortality rate
Time frame: 8 weeks or till patient death which comes first
Incidence of feeding intolerance
Time frame: 8 weeks or till patient discharged
Days to reach full intake
Time frame: 8 weeks or till patient discharge which comes first
Chest x ray change
Time frame: Before intubation and and after 2 hours on assigned mode
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Frequency Oscillatory Ventilation with Volume Guarantee (SLE6000;SLE) and High Frequency Oscillatory Ventilation (SLE6000;SLE) in people with Infant, Premature, Diseases and Respiratory Tract Diseases, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doppler cerebral blood flow velocity measurements (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.