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Fluid Filled Lung Oxygenation Assistance Trial (FFLOAT)

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ClinicalTrials.gov Identifier: NCT03041740
Recruitment Status : Active, not recruiting
First Posted : February 3, 2017
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Auto Dealers Caring for Kids Foundation
Information provided by (Responsible Party):
William Fox, Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE January 30, 2017
First Posted Date  ICMJE February 3, 2017
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE June 27, 2017
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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) 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2017)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluid Filled Lung Oxygenation Assistance Trial
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Perfluorooctyl Bromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03041740
Other Study ID Numbers  ICMJE 12-008686
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party William Fox, Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE Auto Dealers Caring for Kids Foundation
Investigators  ICMJE
Principal Investigator: William Fox, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP