Fluid Filled Lung Oxygenation Assistance Trial (FFLOAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03041740|
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia||Drug: Perfluorooctylbromide(PFOB)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||June 27, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2021|
No Intervention: Usual Care (Control) Group
Control subjects will be maintained on mechanical ventilation and treated per standard of care.
Active Comparator: Perfluorooctylbromide (PFOB) Group
Subjects in the Perfluorooctylbromide (PFOB) Group will be administered an initial Perfluorooctylbromide (PFOB) treatment dose of 2.5 mL/kg and up to a total intra-pulmonary volume of 12.5 mL/kg for up to 10 days
Subjects in the Perfluorooctylbromide (PFOB) Group will be administered an initial Perfluorooctylbromide (PFOB) treatment dose of 2.5 mL/kg and up to a total intra-pulmonary volume of 12.5 mL/kg for up to 10 days.
Other Name: PFOB Group
- Number of PFOB participants with no treatment-related adverse events as assessed by CTCAE v4.03 toxicity Scale. [ Time Frame: Up to 10 days ](1) No sustained oxygen desaturations for greater than ten minutes without response to increased oxygen therapy, (2) persistent hypotension (as defined by ≥ 20% decrease in blood pressure) 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/ pleural effusion with PFOB and (5) no sustained CO2 retention greater than 95 mmHg for over four hours.
- Pulmonary Artery Pressure Response to PFOB [ Time Frame: Up to 10 days ]The effect of PFOB-PLV on pulmonary artery pressure will also be evaluated by obtaining an echocardiogram prior and post instillation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041740
|Contact: William Fox, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: William Fox, MD 215-590-1653 email@example.com|
|Principal Investigator: William Fox, MD|
|Principal Investigator:||William Fox, MD||Children's Hospital of Philadelphia|