Preterm BirthNCT05230485
Optimal High CPAP Pressures in Preterm Neonates Post-extubation
A study testing CPAP level in people with Preterm Birth and Mechanical Ventilation Complication, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 7 days to 37 weeks
- Conditions the study is for
- Preterm Birth, Mechanical Ventilation Complication, Respiratory Distress Syndrome, Newborn
- What is being tested?
- CPAP level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2022to 15 Feb 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 7 days to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age <29 weeks; chronological age >7 days; post-menstrual age <37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O
Who cannot join
- Any congenital or genetic/chromosomal abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal High CPAP Pressures in Preterm Neonates Post-extubation: A Prospective Randomized Crossover Trial
Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. In this study, we will comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
Read the detailed description
Background: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. However, there are limited data on the effectiveness and safety of this mode.
A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. While it could be argued that the initial High CPAP pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (Paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. On the other hand, a suboptimal post-extubation High CPAP level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. As such, research towards identification of the optimal High CPAP level post-extubation from high invasive ventilation pressures is warranted.
Objective: To comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
Hypothesis: We hypothesize that babies extubated from invasive mechanical ventilation with a mean Paw between 9-15 cmH2O will demonstrate better physiological and clinical parameters when using High CPAP+2 cmH2O vs equivalent CPAP levels.
Methods: Design - This will be a prospective, single-centre, randomized cross-over study.
- Conditions
- Preterm Birth, Mechanical Ventilation Complication, Respiratory Distress Syndrome, Newborn
- Being tested
- CPAP level
- Keywords
- Continuous Positive Airway Pressure, Electrical activity of diaphragm, Continuous distending pressure
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP levelOther
The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP
| Study group | Role | What they receive |
|---|---|---|
| Higher CPAP | Experimental | CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure Receives: Other: CPAP level |
| Equivalent CPAP | Active comparator | CPAP level will be equal to the pre-extubation measured mean airway pressure Receives: Other: CPAP level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Edi
The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume
Measured: 60 min following each CPAP level - assessed over 10 min
Secondary outcomes (11)
Minimum EDi
The minimum eelectrical diaphragmatic activity - a surrogate for work of breathing to maintain functional residual capacity
Measured: 60 min following each CPAP level - assessed over 10 min
Regional cerebral perfusion
The cerebral tissue extraction of oxygen - determined by near infra-red spectroscopy
Measured: 60 min following each CPAP level - assessed over 10 min
Pressure level - Ventilator
Pressure level as measured by the ventilator
Measured: 60 min following each CPAP level - assessed over 10 min
Pressure level - Interface
Pressure level at measured at the nasal interface used to deliver CPAP
Measured: 60 min following each CPAP level - assessed over 10 min
Work of breathing score
Using Silverman Scoring
Measured: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Heart Rate
From cardiorespiratory monitoring
Measured: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Respiratory Rate
From cardiorespiratory monitoring
Measured: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Transcutaneous CO2 level
From bedside transcutaneous CO2 monitoring
Measured: Over entire duration (70 min) at each CPAP level, assessed every 10 min
FiO2 level
Fractional inspired oxygen level, as determined by clinical and inputted into ventilator
Measured: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Number of bradycardic episodes <80 bpm
as above
Measured: Over entire duration (70 min) at each CPAP level
Proportion of duration with SpO2 <90%
duration of time where the patient's SpO2 is less than 90%
Measured: Over entire duration (70 min) at each CPAP level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start15 Feb 2022 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Mukerji, McMaster Children's Hospital
- Investigators
- Amit Mukerji, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230485
- Sponsor's protocol ID
- 14289
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 9 Feb 2022
- 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 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal High CPAP Pressures in Preterm Neonates Post-extubation: A Prospective Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05230485
- Acronym / sponsor ID
- 14289
- Conditions
- Preterm Birth, Mechanical Ventilation Complication, Respiratory Distress Syndrome, Newborn
- Keywords
- Continuous Positive Airway Pressure, Electrical activity of diaphragm, Continuous distending pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 9 Feb 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.
Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. In this study, we will comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
Detailed description
Background: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. However, there are limited data on the effectiveness and safety of this mode.
A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. While it could be argued that the initial High CPAP pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (Paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. On the other hand, a suboptimal post-extubation High CPAP level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. As such, research towards identification of the optimal High CPAP level post-extubation from high invasive ventilation pressures is warranted.
Objective: To comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.
Hypothesis: We hypothesize that babies extubated from invasive mechanical ventilation with a mean Paw between 9-15 cmH2O will demonstrate better physiological and clinical parameters when using High CPAP+2 cmH2O vs equivalent CPAP levels.
Methods: Design - This will be a prospective, single-centre, randomized cross-over study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher CPAP | Experimental | Other: CPAP levelCPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure |
| Equivalent CPAP | Active comparator | Other: CPAP levelCPAP level will be equal to the pre-extubation measured mean airway pressure |
Who may qualify
- Ages
- 7 days to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestational age <29 weeks; chronological age >7 days; post-menstrual age <37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O
Key exclusion criteria (1 listed)
- Any congenital or genetic/chromosomal abnormality
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 |
|---|---|---|
| CPAP levelThe level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP | Other | Equivalent CPAP, Higher CPAP |
Primary outcome
Peak Edi
Time frame: 60 min following each CPAP level - assessed over 10 min
The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume
11 secondary outcomes
Minimum EDi
Time frame: 60 min following each CPAP level - assessed over 10 min
Regional cerebral perfusion
Time frame: 60 min following each CPAP level - assessed over 10 min
Pressure level - Ventilator
Time frame: 60 min following each CPAP level - assessed over 10 min
Pressure level - Interface
Time frame: 60 min following each CPAP level - assessed over 10 min
Work of breathing score
Time frame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Heart Rate
Time frame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Respiratory Rate
Time frame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Transcutaneous CO2 level
Time frame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
FiO2 level
Time frame: Over entire duration (70 min) at each CPAP level, assessed every 10 min
Number of bradycardic episodes <80 bpm
Time frame: Over entire duration (70 min) at each CPAP level
Proportion of duration with SpO2 <90%
Time frame: Over entire duration (70 min) at each CPAP level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- 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.
Amit Mukerji, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP level in people with Preterm Birth and Mechanical Ventilation Complication, run by McMaster Children's Hospital at 1 site in Canada.
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 1 inclusion and 1 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 Feb 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 Canada. 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 Amit Mukerji, MD (905-521-2100 ext. 76486, mukerji@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Edi (time frame: 60 min following each CPAP level - assessed over 10 min). 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 Feb 2022.