Title
Fluid Filled Lung Oxygenation Assistance Trial
A Pilot Study to Evaluate the Safety of Perflurooctylbromide (PFOB) Partial Liquid Ventilation (PLV) for Up to 10 Days in Neonates With Severe Bronchopulmonary Dysplasia (BPD)
Phase
Early Phase 1Lead Sponsor
University of PennsylvaniaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Bronchopulmonary DysplasiaIntervention/Treatment
perfluorooctyl bromide ...Study Participants
16The 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.
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.
Control subjects will be treated as per standard of care for preterm infants with BPD.
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.
Inclusion Criteria Neonates with severe BPD as defined by 36 weeks post conception age and require positive pressure ventilation Infants born at less than 32 weeks post conception age Subjects may be up to 6 months corrected age On conventional mechanical ventilation for chronic lung disease for at least two days prior to enrollment On conventional mechanical ventilation at the time of enrollment and anticipated to continue for 14 days Off systemic steroids for lung disease for 72 hours (3 days) prior to T=0 Hemoglobin value ≥8 g/dL: if less than 8 g/dL, transfusion is permitted. Clinical blood transfusion should be administered prior to enrollment. Parental/guardian permission (informed consent) Exclusion Criteria Mechanical ventilation for acute disease, such as for infection or for post-operative complications Severe Pulmonary Hypertension (PAH) (pulmonary pressure greater than 2/3 systemic) as defined by either echocardiogram (ECHO), or cardiac catheterizations or a CT-Angiogram consistent with PAH within the last 3 weeks. Pneumothorax (active air leak) requiring chest tube within 72 hours of T=0 Active pulmonary hemorrhage within 72 hours of T=0 History of Grade III/IV interventricular hemorrhage without resolution or stability within 3 weeks of verifying eligibility Severe congenital heart disease compromising pulmonary circulation Other major congenital malformation (including but not limited to CDH) or known genetic syndromes at the discretion of the investigator Use of an investigational drug within 7 days prior to confirmation of eligibility. The clinical attending physician believes it is not in the subject's and/or parents/guardians best interest to participate in the trial.
