Infant,PrematureNCT03558737
Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
A study testing Nasal high-frequency jet ventilation (nHFJV) and Nasal intermittent positive pressure ventilation (NIPPV) in people with Infant,Premature and Respiratory Failure, run by University of Utah at 2 sites in United States.
Trial summary
Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Infant,Premature, Respiratory Failure, Respiratory Insufficiency
- What is being tested?
- Nasal high-frequency jet ventilation (nHFJV) and Nasal intermittent positive pressure ventilation (NIPPV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 8 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 24 0/7 to 28 6/7 weeks GA
- Intubated within 24 hours of life to synchronized intermittent mandatory ventilation (SIMV) or high frequency ventilation (HFV, includes HFOV or HFJV)
- Plan for extubation within 72 hours of life
- Infants intubated for surfactant replacement therapy via INSURE method (Intubation-Surfactant-Extubation) are eligible
- Consent obtained from parent/legal guardian
Who cannot join
- Major congenital and/or chromosomal anomalies
- Upper oropharyngeal anomalies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84112
Primary Children's Hospital
Salt Lake City, Utah, 84113
About this study
Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD. Thus, it is important to investigate respiratory support methods that are able to effectively oxygenate and ventilate these high risk preterm infants while reducing their risk of lung injury. Nasal high-frequency ventilation is one potential intervention that may decrease the risk of respiratory failure in very low birth weight infants. Small studies have shown effective respiratory support over short time periods in infants, however these studies use nasal high-frequency oscillatory ventilation. To the investigators' knowledge there is no published studies looking at the use of nasal high-frequency jet ventilation in this high risk population.
Use of non-invasive high frequency ventilation (HFV) has been described as a rescue method following failure of other non-invasive ventilator modes or as a means to increase the success post-extubation. When used as invasive high frequency ventilation, high frequency oscillatory ventilation (HFOV) or high frequency jet ventilation (HFJV) utilize supraphysiologic respiratory rates and small tidal volumes which has been shown to inflict less lung injury than conventional modes of ventilation.
Read more
Using a mechanical newborn lung model, nasal HFV has improved CO2 removal when compared to conventional NIPPV. Animal studies in the lab of Kurt Albertine have shown improved ventilation and oxygenation in the high frequency nasal ventilation group versus the mechanical ventilation group in a preterm lamb model leading towards better alveolar formation noted histologically.
The investigators hypothesize that extubation of very preterm infants to nHFJV will significantly decrease the rates of reintubation compared to those infants extubated to NIPPV.
- Conditions
- Infant,Premature, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome in Premature Infant
- Being tested
- Nasal high-frequency jet ventilation (nHFJV), Nasal intermittent positive pressure ventilation (NIPPV)
- Keywords
- non-invasive high frequency ventilation (nHFJV), nasal intermittent positive pressure ventilation (NIPPV)
- Medical subject headings
- Premature Birth, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high-frequency jet ventilation (nHFJV)Other
Non-invasive high-frequency jet ventilation provided via the Bunnell Life Pulse high-frequency JET ventilator through a Rusch latex nasopharyngeal airway
Nasal intermittent positive pressure ventilation (NIPPV)Other
Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
| Study group | Role | What they receive |
|---|---|---|
| Nasal high-frequency jet ventilation (nHFJV) | Active comparator | Not described Receives: Other: Nasal high-frequency jet ventilation (nHFJV) |
| Nasal intermittent positive pressure ventilation (NIPPV) | Active comparator | Not described Receives: Other: Nasal intermittent positive pressure ventilation (NIPPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation
The number of participants who needed to be reintubated during the first 72 hours of initiation of study intervention will be compared between both arms.
Measured: 72 hours
Secondary outcomes (1)
Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)
The number of infants diagnosed with moderate to severe BPD evaluated at 36 weeks corrected gestational age as defined by the 2001 NICHD Consensus Conference, with and without altitude correction will be compared between both arms
Measured: 6 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Apr 2019
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Why it stopped: Study stopped due to safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infant,PrematureStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Model description
- Infants will be stratified by GA (24 0/7 to 25 6/7, 26 0/7 to 28 6/7) and randomized to either nHFJV or NIPPV
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Yoder, University of Utah
- Investigators
- Bradley Yoder, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558737
- Sponsor's protocol ID
- 109858
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2018
- Last updated
- 24 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
- ClinicalTrials.gov ID
- NCT03558737
- Acronym / sponsor ID
- 109858
- Conditions
- Infant,Premature, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome in Premature Infant
- Keywords
- non-invasive high frequency ventilation (nHFJV), nasal intermittent positive pressure ventilation (NIPPV)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to safety reasons.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 24 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD. Thus, it is important to investigate respiratory support methods that are able to effectively oxygenate and ventilate these high risk preterm infants while reducing their risk of lung injury. Nasal high-frequency ventilation is one potential intervention that may decrease the risk of respiratory failure in very low birth weight infants. Small studies have shown effective respiratory support over short time periods in infants, however these studies use nasal high-frequency oscillatory ventilation. To the investigators' knowledge there is no published studies looking at the use of nasal high-frequency jet ventilation in this high risk population.
Use of non-invasive high frequency ventilation (HFV) has been described as a rescue method following failure of other non-invasive ventilator modes or as a means to increase the success post-extubation. When used as invasive high frequency ventilation, high frequency oscillatory ventilation (HFOV) or high frequency jet ventilation (HFJV) utilize supraphysiologic respiratory rates and small tidal volumes which has been shown to inflict less lung injury than conventional modes of ventilation.
Using a mechanical newborn lung model, nasal HFV has improved CO2 removal when compared to conventional NIPPV. Animal studies in the lab of Kurt Albertine have shown improved ventilation and oxygenation in the high frequency nasal ventilation group versus the mechanical ventilation group in a preterm lamb model leading towards better alveolar formation noted histologically.
The investigators hypothesize that extubation of very preterm infants to nHFJV will significantly decrease the rates of reintubation compared to those infants extubated to NIPPV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants will be stratified by GA (24 0/7 to 25 6/7, 26 0/7 to 28 6/7) and randomized to either nHFJV or NIPPV
| Arm | Type | Receives |
|---|---|---|
| Nasal high-frequency jet ventilation (nHFJV) | Active comparator | Other: Nasal high-frequency jet ventilation (nHFJV) |
| Nasal intermittent positive pressure ventilation (NIPPV) | Active comparator | Other: Nasal intermittent positive pressure ventilation (NIPPV) |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 24 0/7 to 28 6/7 weeks GA
- Intubated within 24 hours of life to synchronized intermittent mandatory ventilation (SIMV) or high frequency ventilation (HFV, includes HFOV or HFJV)
- Plan for extubation within 72 hours of life
- Infants intubated for surfactant replacement therapy via INSURE method (Intubation-Surfactant-Extubation) are eligible
- Consent obtained from parent/legal guardian
Key exclusion criteria (2 listed)
- Major congenital and/or chromosomal anomalies
- Upper oropharyngeal anomalies
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 |
|---|---|---|
| Nasal high-frequency jet ventilation (nHFJV)Non-invasive high-frequency jet ventilation provided via the Bunnell Life Pulse high-frequency JET ventilator through a Rusch latex nasopharyngeal airway | Other | Nasal high-frequency jet ventilation (nHFJV) |
| Nasal intermittent positive pressure ventilation (NIPPV)Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs | Other | Nasal intermittent positive pressure ventilation (NIPPV) |
Primary outcome
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation
Time frame: 72 hours
The number of participants who needed to be reintubated during the first 72 hours of initiation of study intervention will be compared between both arms.
1 secondary outcome
Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)
Time frame: 6 to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Bradley Yoder, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal high-frequency jet ventilation (nHFJV) and Nasal intermittent positive pressure ventilation (NIPPV) in people with Infant,Premature and Respiratory Failure, run by University of Utah at 2 sites in United States.
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 5 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: stopped early, as of the sponsor's last update on 24 Jul 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation (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 24 Jul 2024.