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 Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
June 27, 2017
Completion Date
January 2021
Primary Completion Date
December 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
Administrative Informations
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
November 2020