Fluid Filled Lung Oxygenation Assistance Trial

The primary study objective is to assess the safety and feasibility of PFOB as a liquid
breathing medium for up to ten days in subjects with severe BPD as evaluated by: (1) no
sustained oxygen desaturations (SaO2 ≤ 80%) for greater than ten minutes without response to
increased oxygen therapy, (2) no persistent hypotension (as defined by ≥ 20% decrease in
blood pressure) requiring volume expansion and/or inotropic therapy, (3) no major mucus
plugging events (defined as events that are unresolved after two bronchoscopes), (4) no
increase in mechanical ventilator settings predictive of ventilator induced lung injury, and
(5) no pneumothoraces.

Inclusion Criteria

1. Neonates with severe BPD as defined by 36 weeks post conception age and require
positive pressure ventilation

2. Infants born at less than 32 weeks post conception age

3. Subjects may be up to 6 months of age

4. On conventional mechanical ventilation for chronic lung disease for at least two days
prior to enrollment

5. On conventional mechanical ventilation at the time of enrollment and anticipated to
continue for 14 days

6. Off systemic steroids for 72 hours (3 days) prior to T=0

7. Hemoglobin value ≥8 g/dL: if less than 8 g/dL, transfusion is permitted. Clinical
blood transfusion should be administered prior to enrollment.

8. Parental/guardian permission (informed consent)

Exclusion Criteria

1. Mechanical ventilation for acute disease, such as for infection or for post-operative
complications

2. 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.

3. Pneumothorax (active air leak) requiring chest tube within 72 hours of T=0

4. Active pulmonary hemorrhage within 72 hours of T=0

5. History of Grade III/IV interventricular hemorrhage without resolution or stability
within 3 weeks of verifying eligibility

6. Severe congenital heart disease compromising pulmonary circulation

7. Other major congenital malformation (including but not limited to CDH) or known
genetic syndromes at the discretion of the investigator

8. Use of an investigational drug within 7 days prior to confirmation of eligibility.

9. The clinical attending physician believes it is not in the subject's and/or
parents/guardians best interest to participate in the trial.