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 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Failure; Respiratory Insufficiency; Respiratory Distress Syndrome in Premature Infant; Infant,Premature
• Intervention / Treatment: Other: Nasal high-frequency jet ventilation (nHFJV); Other: Nasal intermittent positive pressure ventilation (NIPPV)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Nasal high-frequency jet ventilation (nHFJV)	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
ACTIVE_COMPARATOR: Nasal intermittent positive pressure ventilation (NIPPV)	Other: Nasal intermittent positive pressure ventilation (NIPPV); Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: non-invasive high frequency ventilation (nHFJV); nasal intermittent positive pressure ventilation (NIPPV)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Respiratory Insufficiency; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 109858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No