Clinical trial NCT03558737: Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
Official title: Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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)
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 4
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Exclusion Criteria:

* Major congenital and/or chromosomal anomalies
* Upper oropharyngeal anomalies

Primary outcomes:
measure: 72 Hour Rate of Reintubation to Invasive Mechanical Ventilation
timeFrame: 72 hours
Secondary outcomes:
measure: Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)
timeFrame: 6 to 12 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Bradley Yoder, MD
role: PRINCIPAL_INVESTIGATOR
References: