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| Name | Class |
|---|---|
| Auto Dealers Caring for Kids Foundation | OTHER |
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The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).
The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation for up to ten days in infants with severe BPD as evaluated by: (1) no sustained oxygen desaturations (SpO2 ≤ 80%) for greater than ten minutes without response to increased oxygen therapy, (2) no persistent hypotension without response to volume expansion and/or inotropic therapy, (3) no major mucus plugging events (defined as events that are unresolved after two bronchoscopes), (4) no pneumothoraces or pleural effusion with PFOB, (5) and no evidence of increased carbon dioxide (CO2) retention, renal insufficiency, hyperkalemia, or metabolic acidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (Control) Group | No Intervention | Control subjects will be treated as per standard of care for preterm infants with BPD. | |
| Perfluorooctylbromide (PFOB) Group | Active Comparator | Subjects in the PFOB group will be administered an initial PFOB treatment dose of 2.5 mL/kg and up to a total intra-pulmonary volume of 25 mL/kg for up to 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perfluorooctyl Bromide | Drug | Subjects in the PFOB group will receive PFOB partial liquid ventilation instilled via side port of endotracheal tube (2.5 mL/kg/day) across 10 treatment days. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained oxygen desaturations for greater than ten minutes without response to increased oxygen therapy | Incidence of sustained (greater than 10 minutes) oxygen desaturation events without response to increased oxygen therapy. These incidences will be measured by a continuous non-invasive percutaneous oxygen saturation monitor. | Day 5, Day 10 |
| Persistent hypotension without response to volume expansion and/or inotropic therapy | Incidence of persistent hypotension without response to volume expansion and/or inotropic therapy. Hypotension is a decrease in systolic blood pressure deemed significant by clinical staff. Measurement will be performed with a standard intensive care unit blood pressure cuff. | Day 5, Day 10 |
| Change in number of major mucus plugging events | Incidence of airway obstruction of the endotracheal tube, as indicated by decreased chest movement during mechanical ventilation, need for increased ventilator pressure, and/or elevation of carbon dioxide levels in the blood. Mucus plugs are confirmed by endotracheal suctioning. | Day 5, Day 10 |
| Incidence of pneumothorax or pleural effusion with PFOB | Incidence of pneumothorax in the child will be measured by transillumination of the chest and confirmed by chest x-ray. | Day 5, Day 10 |
| Number of participants with sustained hypercapnia (elevated carbon dioxide in the blood, greater than 95 mmHg, for over four hours). | Hypercapnia will be measured with blood tests and/or cutaneous carbon dioxide monitor. | Day 5, Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fraction of inspired oxygen (FiO2) | Fraction of inspired oxygen is the percentage of oxygen that the patient is receiving for his or her lung disease. An FiO2 of 0.21 is room air oxygen and 1.00 is 100% oxygen. The higher the FiO2, the more severe the respiratory disease. | Day 5, Day 10 |
| Change in ventilator mean airway pressure (MAP) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| William Fox, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37549675 | Derived | Nocentini G, MacLaren G, Bartlett R, De Luca D, Perdichizzi S, Stoppa F, Marano M, Cecchetti C, Biasucci DG, Polito A, AlGhobaishi A, Guner Y, Gowda SH, Hirschl RB, Di Nardo M. Perfluorocarbons in Research and Clinical Practice: A Narrative Review. ASAIO J. 2023 Dec 1;69(12):1039-1048. doi: 10.1097/MAT.0000000000002017. Epub 2023 Aug 7. |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C003072 | perflubron |
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|
Mean airway pressure (MAP) is the average amount of airway pressure supplied to the lungs throughout a breath. Higher MAP indicates more severe disease. |
| Day 5, Day 10 |
| Change in Respiratory Severity Score (MAP x FiO2) | Respiratory Severity Score (RSS) is a scale computed as the Mean Airway Pressure (MAP) multiplied by the Fraction of Inspired Oxygen (FiO2). Clinically, the scale range will often lie between 1 and 10, with higher numbers indicating more severe disease. The RSS can theoretically reach a score as high as 30-35. | Day 5, Day 10 |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |