Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

NCT01939067

Respiratory Distress Lung Injury

WITHDRAWN PHASE1

Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome

NCT03140891

Respiratory Distress Syndrome Preterm Infant

COMPLETED NA

Nasal High Frequency in Preterm Neonates

NCT06687083

Respiratory Distress Syndrome (RDS) Neonatal Diseases and Abnormalities

COMPLETED NA

Successful Extubation and Noninvasive Ventilation in Preterm ≤ 1500g Terms

NCT02396693

Respiratory Distress Syndrome In Premature Infants

COMPLETED NA

Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study

NCT04323397

High-Frequency Ventilation Intermittent Positive-Pressure Ventilation Newborn Morbidity +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant,Premature Respiratory Failure Respiratory Insufficiency Respiratory Distress Syndrome in Premature Infant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasal high-frequency jet ventilation (nHFJV)

Group Type ACTIVE_COMPARATOR

Nasal high-frequency jet ventilation (nHFJV)

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Nasal intermittent positive pressure ventilation (NIPPV)

Intervention Type OTHER

Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Nasal intermittent positive pressure ventilation (NIPPV)

Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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