Fluid Filled Lung Oxygenation Assistance Trial

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: ADAGP Charitable Foundation dba Auto Dealers CARing for Kids Foundation; Auto Dealers Caring for Kids Foundation
• Treatments: Bromides; Perflubron

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.