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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041740
Recruitment Status : Suspended (Full Clinical Hold issued by the FDA due to concerns with sterility assurance.)
First Posted : February 3, 2017
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
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 perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Perfluorooctyl Bromide Phase 1

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.

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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 : September 2020
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 treated as per standard of care for preterm infants with BPD.
Active Comparator: Perfluorooctylbromide (PFOB) Group
Subjects in the PFOB group will be administered an initial PFOB treatment dose of 2.5 mL/kg and up to a total intra-pulmonary volume of 25 mL/kg for up to 10 days.
Drug: Perfluorooctyl Bromide
Subjects in the PFOB group will receive PFOB partial liquid ventilation instilled via side port of endotracheal tube (2.5 mL/kg/day) across 10 treatment days.
Other Name: Perflubron




Primary Outcome Measures :
  1. Sustained oxygen desaturations for greater than ten minutes without response to increased oxygen therapy [ Time Frame: Day 5, Day 10 ]
    Incidence of sustained (greater than 10 minutes) oxygen desaturation events without response to increased oxygen therapy. These incidences will be measured by a continuous non-invasive percutaneous oxygen saturation monitor.

  2. Persistent hypotension without response to volume expansion and/or inotropic therapy [ Time Frame: Day 5, Day 10 ]
    Incidence of persistent hypotension without response to volume expansion and/or inotropic therapy. Hypotension is a decrease in systolic blood pressure deemed significant by clinical staff. Measurement will be performed with a standard intensive care unit blood pressure cuff.

  3. Change in number of major mucus plugging events [ Time Frame: Day 5, Day 10 ]
    Incidence of airway obstruction of the endotracheal tube, as indicated by decreased chest movement during mechanical ventilation, need for increased ventilator pressure, and/or elevation of carbon dioxide levels in the blood. Mucus plugs are confirmed by endotracheal suctioning.

  4. Incidence of pneumothorax or pleural effusion with PFOB [ Time Frame: Day 5, Day 10 ]
    Incidence of pneumothorax in the child will be measured by transillumination of the chest and confirmed by chest x-ray.

  5. Number of participants with sustained hypercapnia (elevated carbon dioxide in the blood, greater than 95 mmHg, for over four hours). [ Time Frame: Day 5, Day 10 ]
    Hypercapnia will be measured with blood tests and/or cutaneous carbon dioxide monitor.


Secondary Outcome Measures :
  1. Change in fraction of inspired oxygen (FiO2) [ Time Frame: Day 5, Day 10 ]
    Fraction of inspired oxygen is the percentage of oxygen that the patient is receiving for his or her lung disease. An FiO2 of 0.21 is room air oxygen and 1.00 is 100% oxygen. The higher the FiO2, the more severe the respiratory disease.

  2. Change in ventilator mean airway pressure (MAP) [ Time Frame: Day 5, Day 10 ]
    Mean airway pressure (MAP) is the average amount of airway pressure supplied to the lungs throughout a breath. Higher MAP indicates more severe disease.

  3. Change in Respiratory Severity Score (MAP x FiO2) [ Time Frame: Day 5, Day 10 ]
    Respiratory Severity Score (RSS) is a scale computed as the Mean Airway Pressure (MAP) multiplied by the Fraction of Inspired Oxygen (FiO2). Clinically, the scale range will often lie between 1 and 10, with higher numbers indicating more severe disease. The RSS can theoretically reach a score as high as 30-35.



Information from the National Library of Medicine

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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 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.

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


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Auto Dealers Caring for Kids Foundation
Investigators
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Principal Investigator: William Fox, MD Children's Hospital of Philadelphia
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Responsible Party: William Fox, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03041740    
Other Study ID Numbers: 12-008686
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Perflubron
Bromides
Anticonvulsants
Anti-Obesity Agents