Fluid Filled Lung Oxygenation Assistance Trial

Brief Title

Fluid Filled Lung Oxygenation Assistance Trial

Official Title

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)

Brief 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).
    

Detailed 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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Sustained oxygen desaturations for greater than ten minutes without response to increased oxygen therapy

Secondary Outcome

 Change in fraction of inspired oxygen (FiO2)

Condition

Bronchopulmonary Dysplasia

Intervention

Perfluorooctyl Bromide

Study Arms / Comparison Groups

 Usual Care (Control) Group

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

June 27, 2017

Completion Date

January 2021

Primary Completion Date

September 2020

Eligibility 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.
      

Gender

All

Ages

N/A - 6 Months

Accepts Healthy Volunteers

No

Contacts

William Fox, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT03041740

Organization ID

12-008686

Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Philadelphia

Collaborators

 Auto Dealers Caring for Kids Foundation

Study Sponsor

William Fox, MD, Principal Investigator, Children's Hospital of Philadelphia

Verification Date

May 2020