Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
Primary Purpose
Infant,Premature, Respiratory Failure, Respiratory Insufficiency
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal high-frequency jet ventilation (nHFJV)
Nasal intermittent positive pressure ventilation (NIPPV)
Sponsored by
About this trial
This is an interventional treatment trial for Infant,Premature focused on measuring non-invasive high frequency ventilation (nHFJV), nasal intermittent positive pressure ventilation (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
Sites / Locations
- University of Utah
- Primary Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nasal high-frequency jet ventilation (nHFJV)
Nasal intermittent positive pressure ventilation (NIPPV)
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03558737
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nasal high-frequency jet ventilation (nHFJV)
Arm Type
Active Comparator
Arm Title
Nasal intermittent positive pressure ventilation (NIPPV)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Nasal high-frequency jet ventilation (nHFJV)
Intervention Description
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
Intervention Name(s)
Nasal intermittent positive pressure ventilation (NIPPV)
Intervention Description
Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
Primary Outcome Measure Information:
Title
72 hour rate of reintubation to invasive mechanical ventilation
Description
Rates of reintubation will be compared between both arms during the first 72 hours of initiation of study intervention
Time Frame
72 hours
Title
7 day rate of reintubation to invasive mechanical ventilation
Description
Rates of reintubation will be compared between both arms for during the 7 day period following transition off of non-invasive study intervention
Time Frame
7 days
Title
Total number of days of invasive mechanical ventilation
Description
The total number of days of infants are intubated and require mechanical ventilation throughout from admission to discharge will be compared between both arms
Time Frame
through hospital discharge, an average of 5 months
Secondary Outcome Measure Information:
Title
Rates of moderate to severe bronchopulmonary dysplasia (BPD)
Description
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
Time Frame
6 to 12 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Yoder, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants
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