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Study stopped due to safety reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal high-frequency jet ventilation (nHFJV) | Active Comparator |
| |
| Nasal intermittent positive pressure ventilation (NIPPV) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal high-frequency jet ventilation (nHFJV) | Other | Non-invasive high-frequency jet ventilation provided via the Bunnell Life Pulse high-frequency JET ventilator through a Rusch latex nasopharyngeal airway |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Yoder, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States | ||
| Primary Children's Hospital |
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Study terminated after only 2 subjects enrolled in each arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Nasal Intermittent Positive Pressure Ventilation (NIPPV) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2019 |
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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
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| Nasal intermittent positive pressure ventilation (NIPPV) | Other | Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs |
|
| Salt Lake City |
| Utah |
| 84113 |
| United States |
Nasal intermittent positive pressure ventilation (NIPPV): Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs |
| COMPLETED |
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| NOT COMPLETED |
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Babies born between 24 weeks and 28 weeks completed gestation were screened for enrollment. This study was terminated early and enrolled three 25 week GA infants and one 28 week GA infant.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Completed weeks gestation at delivery | Mean | Full Range | Weeks |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 2 participants were randomized to each arm. All of the participants required reintubation during the initial 72 hour treatment period. | Posted | Count of Participants | Participants | 72 hours |
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| 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 | One infant in each group had died prior to the evaluation for BPD. | Posted | Number | number participants diagnosed with BPD | 6 to 12 weeks |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 2 | 1 | 2 | 0 | 2 |
| EG001 | 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 | 1 | 2 | 2 | 2 | 0 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraventricular Hemorrhage (IVH) | Nervous system disorders | Systematic Assessment | Very preterm infants are at high risk for developing IVH and routine head ultrasounds are done at 7-10 days. All infants were diagnosed with a grade 4 IVH but were not related to the study. |
| |
| Spontaneous Intestinal Perforation | Gastrointestinal disorders | Systematic Assessment |
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This study was terminated early due to concerns related to the spontaneous intestinal perforation and abdominal distension that is inherent with all forms of nasal respiratory support. There is not enough data to run statistical analysis on and there is no way to make any meaningful conclusions.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Yoder | University of Utah | 801-581-7052 | bradley.yoder@hsc.utah.edu |
| Nov 27, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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