Clinical Trial: Fluid Filled Lung Oxygenation Assistance Trial
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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 (
Brief Summary: 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 Bronchopulmonary Dysplasia (BPD).
Detailed Summary: 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.
Sponsor: Children's Hospital of Philadelphia
Current Primary Outcome: Number of PFOB participants with no treatment-related adverse events as assessed by CTCAE v4.03 toxicity Scale. [ Time Frame: Up to 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Pulmonary Artery Pressure Response to PFOB [ Time Frame: Up to 10 days ]
Original Secondary Outcome: Same as current
Information By: Children's Hospital of Philadelphia
Dates:
Date Received: January 30, 2017
Date Started: April 2017
Date Completion: January 2021
Last Updated: February 1, 2017
Last Verified: February 2017
