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NCT03558737 · ClinicalTrials.gov registry record · NA
Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
A NA study, sponsored by University of Utah.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT03558737: Clinical Trial NA study, sponsored by University of Utah.
NCT03558737 is a NA study that was terminated before completion, run by University of Utah. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03558737, a NA study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- OTHER Nasal intermittent positive pressure ventilation (NIPPV)
- OTHER Nasal high-frequency jet ventilation (nHFJV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2022-02-08 |
| Phase | NA |
Why NCT03558737 stopped before completion
NCT03558737 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Nasal intermittent positive pressure ventilation (NIPPV) is the first listed.
NCT03558737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03558737 about?
NCT03558737 is a clinical study titled "Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants". 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 effecti...
What is the current status of trial NCT03558737?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2019-04-01. Estimated completion is 2022-02-08.
What interventions are being tested in trial NCT03558737?
The interventions under investigation include: Nasal intermittent positive pressure ventilation (NIPPV) (OTHER), Nasal high-frequency jet ventilation (nHFJV) (OTHER).
Who is sponsoring clinical trial NCT03558737?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03558737's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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