Infant,Premature, Respiratory Failure, Respiratory Insufficiency, Respiratory Distress Syndrome in Premature Infant
Conditions
Keywords
non-invasive high frequency ventilation (nHFJV), nasal intermittent positive pressure ventilation (NIPPV)
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.
Interventions
OTHERNasal 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
Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 72 Hour Rate of Reintubation to Invasive Mechanical Ventilation | 72 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD) | 6 to 12 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
Study terminated after only 2 subjects enrolled in each arm.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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 | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
Baseline characteristics
| Characteristic | Nasal High-frequency Jet Ventilation (nHFJV) | Nasal Intermittent Positive Pressure Ventilation (NIPPV) | Total |
|---|---|---|---|
| Age, Customized GA at delivery | 26.5 Weeks | 25 Weeks | 25.75 Weeks |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 1 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 | 2 / 2 |
Outcome results
Primary
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation
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.
Time frame: 72 hours
Population: 2 participants were randomized to each arm. All of the participants required reintubation during the initial 72 hour treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal High-frequency Jet Ventilation (nHFJV) | 72 Hour Rate of Reintubation to Invasive Mechanical Ventilation | 2 Participants |
| Nasal Intermittent Positive Pressure Ventilation (NIPPV) | 72 Hour Rate of Reintubation to Invasive Mechanical Ventilation | 2 Participants |
Secondary
Rates of Moderate to Severe Bronchopulmonary Dysplasia (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
Time frame: 6 to 12 weeks
Population: One infant in each group had died prior to the evaluation for BPD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasal High-frequency Jet Ventilation (nHFJV) | Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD) | 1 number participants diagnosed with BPD |
| Nasal Intermittent Positive Pressure Ventilation (NIPPV) | Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD) | 1 number participants diagnosed with BPD |