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Fluid Filled Lung Oxygenation Assistance Trial (FFLOAT)

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ClinicalTrials.gov Identifier: NCT03041740
Recruitment Status : Recruiting
First Posted : February 3, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
ADAGP Charitable Foundation dba Auto Dealers CARing for Kids Foundation
Information provided by (Responsible Party):
William Fox, Children's Hospital of Philadelphia

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).

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Perfluorooctylbromide(PFOB) Early Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Perfluorooctylbromide(PFOB)
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 of 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 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.

Information from the National Library of Medicine

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


Contacts
Contact: William Fox, MD 215-590-1653 fox@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: William Fox, MD    215-590-1653    fox@email.chop.edu   
Principal Investigator: William Fox, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
ADAGP Charitable Foundation dba Auto Dealers CARing for Kids Foundation
Investigators
Principal Investigator: William Fox, MD Children's Hospital of Philadelphia

Responsible Party: William Fox, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03041740     History of Changes
Other Study ID Numbers: 12-008686
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by William Fox, Children's Hospital of Philadelphia:
Bronchopulmonary Dysplasia
Neonates

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Perflubron
Anti-Obesity Agents