Trial Outcomes & Findings for Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants (NCT NCT03558737)

NCT ID: NCT03558737

Last Updated: 2024-07-24

Results Overview

The number of participants who needed to be reintubated during the first 72 hours of initiation of study intervention will be compared between both arms.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2024-07-24

Participant Flow

Study terminated after only 2 subjects enrolled in each arm.

Participant milestones

Measure	Nasal High-frequency Jet Ventilation (nHFJV) 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) Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
Overall Study STARTED	2	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Nasal High-frequency Jet Ventilation (nHFJV) 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) Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
Overall Study Death	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Nasal High-frequency Jet Ventilation (nHFJV) n=2 Participants 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) n=2 Participants Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs	Total n=4 Participants Total of all reporting groups
Age, Customized GA at delivery	26.5 Weeks n=2 Participants	25 Weeks n=2 Participants	25.75 Weeks n=4 Participants
Sex: Female, Male Female	1 Participants n=2 Participants	1 Participants n=2 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=2 Participants	1 Participants n=2 Participants	2 Participants n=4 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 72 hours

Population: 2 participants were randomized to each arm. All of the participants required reintubation during the initial 72 hour treatment period.

The number of participants who needed to be reintubated during the first 72 hours of initiation of study intervention will be compared between both arms.

Outcome measures

Measure	Nasal High-frequency Jet Ventilation (nHFJV) n=2 Participants 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) n=2 Participants Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 to 12 weeks

Population: One infant in each group had died prior to the evaluation for BPD.

The number of infants diagnosed with moderate to severe BPD evaluated 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

Outcome measures

Measure	Nasal High-frequency Jet Ventilation (nHFJV) n=1 Participants 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) n=1 Participants Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)	1 number participants diagnosed with BPD	1 number participants diagnosed with BPD

Adverse Events

Nasal High-frequency Jet Ventilation (nHFJV)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Nasal High-frequency Jet Ventilation (nHFJV) n=2 participants at risk 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) n=2 participants at risk Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
Nervous system disorders Intraventricular Hemorrhage (IVH)	50.0% 1/2 • Number of events 1 • Adverse events collected from placement on nasal respiratory support as randomized through 7 days after started on designated respiratory therapy. All-cause mortality was monitorted during the entire initial hospitalization, an average of 4 months. All participants in the study were inpatients and received 24 hour care. Routine assessments such as head ultrasounds and xrays were reviewed by the research team for adverse events.	100.0% 2/2 • Number of events 2 • Adverse events collected from placement on nasal respiratory support as randomized through 7 days after started on designated respiratory therapy. All-cause mortality was monitorted during the entire initial hospitalization, an average of 4 months. All participants in the study were inpatients and received 24 hour care. Routine assessments such as head ultrasounds and xrays were reviewed by the research team for adverse events.
Gastrointestinal disorders Spontaneous Intestinal Perforation	50.0% 1/2 • Number of events 1 • Adverse events collected from placement on nasal respiratory support as randomized through 7 days after started on designated respiratory therapy. All-cause mortality was monitorted during the entire initial hospitalization, an average of 4 months. All participants in the study were inpatients and received 24 hour care. Routine assessments such as head ultrasounds and xrays were reviewed by the research team for adverse events.	0.00% 0/2 • Adverse events collected from placement on nasal respiratory support as randomized through 7 days after started on designated respiratory therapy. All-cause mortality was monitorted during the entire initial hospitalization, an average of 4 months. All participants in the study were inpatients and received 24 hour care. Routine assessments such as head ultrasounds and xrays were reviewed by the research team for adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Bradley Yoder

University of Utah

Phone: 801-581-7052

Email: bradley.yoder@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place