Fluid Filled Lung Oxygenation Assistance Trial (FFLOAT)

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 1

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Perfluorooctyl Bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT03041740

12-008686

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 corrected 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 lung disease 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Usual Care (Control) Group

No Intervention group

Description:

Control subjects will be treated as per standard of care for preterm infants with BPD.

Perfluorooctylbromide (PFOB) Group

Active Comparator group

Description:

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.

Treatment:

Drug: Perfluorooctyl Bromide