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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03558737
• Other study ID #: 109858
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Infant,Premature
• Premature Birth
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• 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
• Nasal intermittent positive pressure ventilation (NIPPV)
Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs

Locations

Country	Name	City	State
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	72 hour rate of reintubation to invasive mechanical ventilation	Rates of reintubation will be compared between both arms during the first 72 hours of initiation of study intervention	72 hours
Primary	7 day rate of reintubation to invasive mechanical ventilation	Rates of reintubation will be compared between both arms for during the 7 day period following transition off of non-invasive study intervention	7 days
Primary	Total number of days of invasive mechanical ventilation	The total number of days of infants are intubated and require mechanical ventilation throughout from admission to discharge will be compared between both arms	through hospital discharge, an average of 5 months
Secondary	Rates of moderate to severe bronchopulmonary dysplasia (BPD)	Rates moderate to severe BPD diagnosed 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	6 to 12 weeks