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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 is a NA study that was terminated before completion, run by University of Utah. The registered enrollment target is 4 participants.

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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.

Interventions

  • OTHER Nasal intermittent positive pressure ventilation (NIPPV)
  • OTHER Nasal high-frequency jet ventilation (nHFJV)

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2019-04-01
Est. Completion 2022-02-08
Phase NA

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT03558737

The ClinicalTrials.gov registry entry for NCT03558737 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Nasal intermittent positive pressure ventilation (NIPPV) is the first listed.

NCT03558737 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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