Infant, Premature, DiseasesNCT05493527
Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates
A study testing noninvasive high frequency oscillatory ventilation and noninvasive positive pressure ventilation in people with Infant, Premature, Diseases and Infant, Newborn, Disease, run by Ain Shams University at 1 site in Egypt.
Trial summary
A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS) Read more about this study
- Who is it for?
- Ages 1 minute to 1 month
- Conditions the study is for
- Infant, Premature, Diseases, Infant, Newborn, Disease, Respiratory Tract Diseases
- What is being tested?
- noninvasive high frequency oscillatory ventilation and noninvasive positive pressure ventilation
- 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
- 1 Feb 2021to 30 Aug 2022
- 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 minute to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm neonates with gestational age ≤ 35 weeks.
- Neonates that were on invasive mechanical ventilation for at least 48 hours eligible for extubation
Who cannot join
- Patients with major upper or lower airway anomalies.
- Patients with significant congenital anomalies including cardiac, abdominal or respiratory.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo, Abbasia, 11517
Sondos Ahmed, 01094407204 ext. 202, sondosahmed@med.asu.edu.eg
sondosahmedsalah@gmail.com
About this study
Official title: Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial
A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)
Read the detailed description
The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown.
Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP.
The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure.
This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP.
The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.
- Being tested
- noninvasive high frequency oscillatory ventilation, noninvasive positive pressure ventilation
- Keywords
- noninvasive high frequency ventilation, noninvasive ventilation, RDS, post-extubation, preterm, respiratory distress syndrome, noninvasive positive pressure ventilation
- Medical subject headings
- Infant, Premature, Diseases, Disease, Respiratory Tract Diseases, Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive high frequency oscillatory ventilationDevice
A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows:
- a frequency of 10 Hertz ( range, 8-12 Hz);
- an inspiratory time of 50% (1:1)
- an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space
- Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy
- fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.
noninvasive positive pressure ventilationDevice
NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on:
- Peep ranging from 5 to 10 cmH2O,
- Peak inspiratory pressure range 15-25 cmH2O
- Rate range 40-50 breath/minute
- FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.
| Study group | Role | What they receive |
|---|---|---|
| noninvasive high frequency oscillatory ventilation (NHFOV) | Experimental | After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support Receives: Device: noninvasive high frequency oscillatory ventilation |
| noninvasive positive pressure ventilation (NIPPV) | Active comparator | After documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support Receives: Device: noninvasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intubation rate
Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.
Measured: 72 hours
Secondary outcomes (16)
Days on the assigned non-invasive respiratory support
To document number of days on the assigned non-invasive respiratory support
Measured: 8 weeks or till patient discharge which comes first
Days on supplemental oxygen
To document number of days on supplemental oxygen
Measured: 8 weeks or till patient discharge which comes first
Duration of admission
To document total number of days of admission
Measured: 8 weeks or till patient discharge which comes first
Mortality rate
To document incidence of mortality during hospitalization
Measured: 8 weeks or till patient death which comes first
Lung ultrasound score
lung ultrasound was performed to all patients before extubation and 2 hours after extubation to assess lung aeration. Score ranges from 0 to 18 .Higher score indicates worse lung aeration.
Measured: Before extubation and after 2 hours on assigned mode
Co2 change
Co2 change in patients on assigned mode using venous blood gases performed before extubation and 2 hours after.
Measured: Before extubation and after 2 hours on assigned mode
Oxygen requirement
Fraction of inspired oxygen required to patients on assigned mode
Measured: Before extubation and after 2 hours on assigned mode
Incidence of feeding intolerance
Percentage of Patients who developed feeding intolerance on the assigned noninvasive mode to the total number of patients assigned to that mode.
Measured: 8 weeks or till patient weaning from assigned mode which comes first
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
Intracranial hemorrhage
Percentage of patients developing intracranial hemorrhage on the assigned noninvasive mode to the total number of patients assigned to that mode.
Measured: 8 weeks or till patient weaning from assigned mode which comes first
Pneumothorax
Percentage of patients developing pneumothorax on the assigned noninvasive mode to the total number of patients assigned to that mode.
Measured: 8 weeks or till patient weaning from assigned mode which comes first
Incidence of occurrence of Nasal trauma
Percentage of patients developing nasal trauma on the assigned noninvasive mode to the total number of patients assigned to that mode.
Measured: 8 weeks or till patient weaning from assigned mode which comes first
incidence of bronchopulmonary dysplasia
Need for supplemental oxygen for at least 28 days, percentage of these patients on the assigned noninvasive mode to the total number of patients assigned to that mode.
Measured: 8 weeks or till patient discharge which comes first
Severity of respiratory distress
Assessment of work of breathing on assigned mode by Downe 's score. Score ranges from 0 till 10 . Higher score indicates worse work of breathing.
Measured: Before extubation and and after 2 hours on assigned mode
Need for Postnatal Steroids
Percentage of patients who needed postnatal steroids administration
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 extubation 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 posted9 Aug 2022
- Study start1 Feb 2021
- Primary completion15 Aug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sondos Ahmed Salaheldin Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493527
- Sponsor's protocol ID
- MD 90/2020
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Preterm Neonates: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05493527
- Acronym / sponsor ID
- MD 90/2020
- Keywords
- noninvasive high frequency ventilation, noninvasive ventilation, RDS, post-extubation, preterm, respiratory distress syndrome, noninvasive positive pressure ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 9 Aug 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 trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)
Detailed description
The use of noninvasive respiratory support (NRS) has increased in recent decades in Neonatal Intensive Care Unit (NICU) as a means to reduce ventilator-induced lung injury. Various modes of NRS are available and in common use. However despite extensive research, the optimal modality of noninvasive modes remain unknown.
Noninvasive high-frequency oscillatory ventilation (NHFOV) is a relatively new mode. It consists of the application of a continuous distending positive pressure with superimposed oscillations. It is a method of augmenting Continuous positive airway pressure (CPAP) support potentially combining the advantages of both high-frequency oscillatory ventilation and CPAP.
The new NHFOV technique offers improved carbon dioxide (CO2) removal and increased functional residual capacity. The superimposed oscillations of NHFOV are thought to help avoid gas trapping and upregulate mean airway pressure.
This technique is also characterized by lower tidal volume resulting in fewer barotraumas /volutraumas and not needing synchronization. NHFOV was considered a strengthened version of CPAP.
The hypothesis is that NHFOV might be superior to NIPPV as a post-extubation respiratory support strategy to avoid reintubation and subsequent complications and/or sequelae in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| noninvasive high frequency oscillatory ventilation (NHFOV) | Experimental | Device: noninvasive high frequency oscillatory ventilationAfter documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NHFOV as post extubation noninvasive respiratory support |
| noninvasive positive pressure ventilation (NIPPV) | Active comparator | Device: noninvasive positive pressure ventilationAfter documenting parental consent, the ventilated infants eligible for extubation were randomly assigned to NIPPV as post extubation noninvasive respiratory support |
Who may qualify
- Ages
- 1 minute 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 that were on invasive mechanical ventilation for at least 48 hours eligible for extubation
Key exclusion criteria (2 listed)
- Patients with major upper or lower airway anomalies.
- Patients 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 |
|---|---|---|
| noninvasive high frequency oscillatory ventilationA time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows: 1. a frequency of 10 Hertz ( range, 8-12 Hz); 2. an inspiratory time of 50% (1:1) 3. an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space 4. Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy 5. fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter. | Device | noninvasive high frequency oscillatory ventilation (NHFOV) |
| noninvasive positive pressure ventilationNIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on: 1. Peep ranging from 5 to 10 cmH2O, 2. Peak inspiratory pressure range 15-25 cmH2O 3. Rate range 40-50 breath/minute 4. FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter. | Device | noninvasive positive pressure ventilation (NIPPV) |
Primary outcome
Re-intubation rate
Time frame: 72 hours
Percentage of Patients who failed weaning on the assigned noninvasive mode and needed reintubation to the total number of patients assigned to that mode.
16 secondary outcomes
Days on the assigned non-invasive respiratory support
Time frame: 8 weeks or till patient discharge which comes first
Days on supplemental oxygen
Time frame: 8 weeks or till patient discharge which comes first
Duration of admission
Time frame: 8 weeks or till patient discharge which comes first
Mortality rate
Time frame: 8 weeks or till patient death which comes first
Lung ultrasound score
Time frame: Before extubation and after 2 hours on assigned mode
Co2 change
Time frame: Before extubation and after 2 hours on assigned mode
Oxygen requirement
Time frame: Before extubation and after 2 hours on assigned mode
Incidence of feeding intolerance
Time frame: 8 weeks or till patient weaning from assigned mode which comes first
Days to reach full intake
Time frame: 8 weeks or till patient discharge which comes first
Intracranial hemorrhage
Time frame: 8 weeks or till patient weaning from assigned mode which comes first
Pneumothorax
Time frame: 8 weeks or till patient weaning from assigned mode which comes first
Incidence of occurrence of Nasal trauma
Time frame: 8 weeks or till patient weaning from assigned mode which comes first
incidence of bronchopulmonary dysplasia
Time frame: 8 weeks or till patient discharge which comes first
Severity of respiratory distress
Time frame: Before extubation and and after 2 hours on assigned mode
Need for Postnatal Steroids
Time frame: 8 weeks or till patient discharge which comes first
Chest x ray change
Time frame: Before extubation and and after 2 hours on assigned mode
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive high frequency oscillatory ventilation and noninvasive positive pressure ventilation in people with Infant, Premature, Diseases and Infant, Newborn, Disease, 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sondos Ahmed (0109440704 ext. 202, sondosahmedsalah@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intubation rate (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 9 Aug 2022.