Respiratory Distress SyndromeNCT01852916
NHFOV Versus NCPAP to Prevent Exubation Failure
A study testing CPAP and NHFOV in people with Respiratory Distress Syndrome, run by University of Manitoba at 2 sites in Canada.
Trial summary
The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and mechanical ventilation in preterm infants less than 28 weeks gestation following first attempt at extubation and removal from mechanical… Read more about this study
- Who is it for?
- Ages 15 minutes to 7 days
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- CPAP and NHFOV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2013to Dec 2015
- 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 15 minutes to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn less than 28 weeks gestation at birth
- Intubated and ventilated in the first 24 hours of life
- Extubated in the first week of life
- Parental consent
Who cannot join
- Lack of parental consent
- Major congenital malformation
- Severe perinatal asphyxia
- Airway abnormalities
- Pneumothorax
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Sciences Center, NICU
Winnipeg, Manitoba, R3A 1S1
About this study
Official title: Nasal High Frequency Oscillatory Ventilation (NHFOV) Versus Nasal Continuous Positive Airway Pressure (NCPAP) Ventilation: a Pilot Trial
The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and mechanical ventilation in preterm infants less than 28 weeks gestation following first attempt at extubation and removal from mechanical ventilation
Read the detailed description
Extremely preterm infants frequently need to be placed back on invasive mechanical ventilation following initial attempts to remove them from this mode of respiratory support. Continued mechanical ventilation is thought to be the primary driver in the development of chronic lung disease and a major component in adverse developmental outcome of these infants. Infants fail their first trial of removal from ventilation because of apnea and respiratory failure. Animal studies and early clinical experience suggest that it is possible to effectively provide ventilation via high frequency nasal ventilation. In the animal models this mode of ventilation appears to provide for better lung development and less injury.
Nasal CPAP has been shown to improve the success rate of extubation from mechanical ventilation by preventing post extubation atelectasis with resultant improvements in gas exchange. However in many of the most premature infants, poorly developed control of respiratory drive is a major problem and despite treatment with caffeine, mechanical ventilation is needed. High frequency nasal ventilation may support ventilation enough during apneic periods to mitigate the need for traditional mechanical ventilation. Use of non-invasive modes may result in a decrease in the incidence and or severity of chronic lung problems and developmental disability of this group of infants.
Extremely premature infants (GA <28 weeks) less than 7 days old will be randomized to either NHFV or nCPAP following the first attempt at extubation and removal from mechanical ventilation. All infants will have received at least a loading dose of caffeine citrate (10 mg/kg of caffeine base equivalent prior to extubation. Initial nCPAP level will be determined by clinical staff but will be at least equal to the level of positive end expiratory pressure (PEEP) used during mechanical ventilation. A similar level of pressure will be used as initial mean airway pressure (MAP) in infants receiving HFNV.
The primary outcome will be need for reintubation during the first 7 days after extubation attempt due to preset criteria. Crossover to the other modality will not be allowed during this period. Infants may remain on HFNF beyond the 7 day primary endpoint if deemed necessary by the clinical staff. Weaning of HFNV to nCPAP will be allowed during the 7 day primary study period and reinstitution of HFNF will be allowed for those initially randomized to that mode of respiratory support.
The magnitude of the effect size cannot be determined as there are no studies to base a sample size calculation on. A pragmatic sample size of 20 infants was selected (10 in each arm) to allow estimation of any potential effect size. Further study(ies) will need to be performed to show conclusively efficacy (or lack) of NHFV to prevent post-extubation respiratory failure or its use in preventing chronic lung disease or improving developmental outcomes.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- CPAP, NHFOV
- Keywords
- RDS
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Nasal Continuous Positive Airway Pressure Ventilation using Infant Flow CPAP machine
NHFOVDevice
Nasal High Frequency Oscillatory Ventilation
| Study group | Role | What they receive |
|---|---|---|
| Nasal CPAP | Active comparator | Nasal CPAP using Infant flow Receives: Device: CPAP |
| NHFOV | Experimental | Nasal High Frequency Oscillatory Ventilation using Dräger Babylog® VN500 ventilator machine Receives: Device: NHFOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Newborns in both groups will be re-intubated within the study period if they have respiratory failure defined as arterial or capillary gas with pH < 7.20 or PCO2 > 60, oxygen requirement ≥ 35%, or recurrent or severe apnea (12 documented apneas within 24 hours or single apnea requiring positive pressure ventilation).
Measured: within 7 days post-extubation
Secondary outcomes (4)
Changes in capillary pCO2 after extubation
capillary pCO2 values will be measured after extubation. Timing and frequency of blood gas sampling will be determined by clinical staff caring for infant and will not be specified by study protocol.
Measured: Within 7 days post-extubation
pneumothorax
incidence of pneumothorax during use of either nasal CPAP or high frequency nasal ventilation will be documented.
Measured: duration of use of positive pressure or reintubation which ever is shorter
intraventricular hemorrage (IVH)
Infants will be screened for IVH per routine clinical care. Incidence of total IVH and severe IVH will be compared between treatments.
Measured: first 2 weeks of life
feeding tolerance
The time to achieve full enteral feeding (135 ml/kg/d) will be compared for both treatments
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Poor recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yaser Ali, University of Manitoba
- Investigators
- Ronald J Baier, M.D., Study director, HSC Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852916
- Sponsor's protocol ID
- B2013: 040
- Status last verified
- Aug 2015
- First submitted
- 17 Apr 2013
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Frequency Oscillatory Ventilation (NHFOV) Versus Nasal Continuous Positive Airway Pressure (NCPAP) Ventilation: a Pilot Trial
- ClinicalTrials.gov ID
- NCT01852916
- Acronym / sponsor ID
- B2013: 040
- Conditions
- Respiratory Distress Syndrome
- Keywords
- RDS
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Poor recruitment rate
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 14 May 2013 (estimated)
- 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.
The purpose of the study is to assess whether nasal high frequency ventilation (NHFV) is superior to nasal continuous positive pressure (nCPAP) to prevent tracheal intubation and mechanical ventilation in preterm infants less than 28 weeks gestation following first attempt at extubation and removal from mechanical ventilation
Detailed description
Extremely preterm infants frequently need to be placed back on invasive mechanical ventilation following initial attempts to remove them from this mode of respiratory support. Continued mechanical ventilation is thought to be the primary driver in the development of chronic lung disease and a major component in adverse developmental outcome of these infants. Infants fail their first trial of removal from ventilation because of apnea and respiratory failure. Animal studies and early clinical experience suggest that it is possible to effectively provide ventilation via high frequency nasal ventilation. In the animal models this mode of ventilation appears to provide for better lung development and less injury.
Nasal CPAP has been shown to improve the success rate of extubation from mechanical ventilation by preventing post extubation atelectasis with resultant improvements in gas exchange. However in many of the most premature infants, poorly developed control of respiratory drive is a major problem and despite treatment with caffeine, mechanical ventilation is needed. High frequency nasal ventilation may support ventilation enough during apneic periods to mitigate the need for traditional mechanical ventilation. Use of non-invasive modes may result in a decrease in the incidence and or severity of chronic lung problems and developmental disability of this group of infants.
Extremely premature infants (GA <28 weeks) less than 7 days old will be randomized to either NHFV or nCPAP following the first attempt at extubation and removal from mechanical ventilation. All infants will have received at least a loading dose of caffeine citrate (10 mg/kg of caffeine base equivalent prior to extubation. Initial nCPAP level will be determined by clinical staff but will be at least equal to the level of positive end expiratory pressure (PEEP) used during mechanical ventilation. A similar level of pressure will be used as initial mean airway pressure (MAP) in infants receiving HFNV.
The primary outcome will be need for reintubation during the first 7 days after extubation attempt due to preset criteria. Crossover to the other modality will not be allowed during this period. Infants may remain on HFNF beyond the 7 day primary endpoint if deemed necessary by the clinical staff. Weaning of HFNV to nCPAP will be allowed during the 7 day primary study period and reinstitution of HFNF will be allowed for those initially randomized to that mode of respiratory support.
The magnitude of the effect size cannot be determined as there are no studies to base a sample size calculation on. A pragmatic sample size of 20 infants was selected (10 in each arm) to allow estimation of any potential effect size. Further study(ies) will need to be performed to show conclusively efficacy (or lack) of NHFV to prevent post-extubation respiratory failure or its use in preventing chronic lung disease or improving developmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal CPAP | Active comparator | Device: CPAPNasal CPAP using Infant flow |
| NHFOV | Experimental | Device: NHFOVNasal High Frequency Oscillatory Ventilation using Dräger Babylog® VN500 ventilator machine |
Who may qualify
- Ages
- 15 minutes to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborn less than 28 weeks gestation at birth
- Intubated and ventilated in the first 24 hours of life
- Extubated in the first week of life
- Parental consent
Key exclusion criteria (5 listed)
- Lack of parental consent
- Major congenital malformation
- Severe perinatal asphyxia
- Airway abnormalities
- Pneumothorax
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 |
|---|---|---|
| CPAPNasal Continuous Positive Airway Pressure Ventilation using Infant Flow CPAP machine | Device | Nasal CPAP |
| NHFOVNasal High Frequency Oscillatory Ventilation | Device | NHFOV |
Primary outcome
Extubation failure
Time frame: within 7 days post-extubation
Newborns in both groups will be re-intubated within the study period if they have respiratory failure defined as arterial or capillary gas with pH < 7.20 or PCO2 > 60, oxygen requirement ≥ 35%, or recurrent or severe apnea (12 documented apneas within 24 hours or single apnea requiring positive pressure ventilation).
4 secondary outcomes
Changes in capillary pCO2 after extubation
Time frame: Within 7 days post-extubation
pneumothorax
Time frame: duration of use of positive pressure or reintubation which ever is shorter
intraventricular hemorrage (IVH)
Time frame: first 2 weeks of life
feeding tolerance
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
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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.
Ronald J Baier, M.D. study director
HSC Neonatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and NHFOV in people with Respiratory Distress Syndrome, run by University of Manitoba at 2 sites 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 4 inclusion and 5 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: paused, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Extubation failure (time frame: within 7 days post-extubation). 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 5 Aug 2015.