Back to resultsInfasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
Primary Purpose
Bronchiolitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aerosolized Infasurf
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
- Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
- Within 4 hours of PICU admission.
Exclusion Criteria:
- Need for non-invasive BiPAP or invasive ventilation
Significant Co-morbidities
- Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
- Unrepaired congenital heart disease
- Immune compromise
- Neuromuscular weakness
- Tracheostomy
- Influenza as the etiologic agent of bronchiolitis
- Inability to stabilize the infant to a bronchiolitis score < 8
Sites / Locations
- Children's Hospital of Richmond at VCU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Usual Care
Arm Description
Subjects randomized to the aerosol surfactant evaluation will occur at the end of 60 minutes, with the aerosol continued if the bronchiolitis score is > 4 or there has been less than a 2-point improvement in the bronchiolitis score. Similar evaluation will be performed, if necessary, at 30-minute intervals (maximum 2 hours) with stoppage of the aerosol for an improved bronchiolitis score (≤ 4 or 2-point improvement) at any of the time points. The aerosol would be stopped at any time for significant sustained deterioration in clinical status or any serious adverse event felt related to the treatment. Retreatment can be given at > 4 but < 24 hours if the initial response was positive and there has been subsequent deterioration.
The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®.
Outcomes
Primary Outcome Measures
Improvement in Respiratory Status
Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.
Secondary Outcome Measures
Need of Respiratory support
Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03748173
Brief Title
Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
Official Title
Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
slowdown due to covid
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
October 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONY
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.
Detailed Description
This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine
Do bronchiolitis patients tolerate aerosolized Infasurf?
Does aerosolized Infasurf induce an improvement in respiration?
If it does how large a dose is required to observe a positive effect?
Is the positive effect transient, if so what is the range of duration of the effect?
Does retreatment also result and a positive response?
Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects randomized to the aerosol surfactant evaluation will occur at the end of 60 minutes, with the aerosol continued if the bronchiolitis score is > 4 or there has been less than a 2-point improvement in the bronchiolitis score. Similar evaluation will be performed, if necessary, at 30-minute intervals (maximum 2 hours) with stoppage of the aerosol for an improved bronchiolitis score (≤ 4 or 2-point improvement) at any of the time points. The aerosol would be stopped at any time for significant sustained deterioration in clinical status or any serious adverse event felt related to the treatment. Retreatment can be given at > 4 but < 24 hours if the initial response was positive and there has been subsequent deterioration.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®.
Intervention Type
Combination Product
Intervention Name(s)
Aerosolized Infasurf
Other Intervention Name(s)
Calfactant
Intervention Description
Infants randomized to aerosol treatment will receive Infasurf® aerosol at a rate of 12 ml/hour (the maximal rate using the Solaris CAG). The initial treatment will be for 60 minutes, with reevaluation every 30 minutes thereafter, with a maximum dose of 6 mL/Kg body weight or 2 hours of aerosolization. Treatment will be stopped after 60 minutes (and subsequently at 30-minute intervals) if a 2 point reduction in bronchiolitis score or a score ≤ 4 is achieved. Treatment will also be stopped at any time should there be evidence of other-than-transient deterioration in oxygenation or clinical status or for any serious adverse effect deemed by the infant's clinician to be possibly related to the drug administration.
Primary Outcome Measure Information:
Title
Improvement in Respiratory Status
Description
Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.
Time Frame
24 hours post PICU admission
Secondary Outcome Measure Information:
Title
Need of Respiratory support
Description
Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation
Time Frame
24 hours post PICU admission
Other Pre-specified Outcome Measures:
Title
Dose as Measured as duration of the therapy
Description
To determine the optimal dose/duration of aerosolized Infasurf® in infants with bronchiolitis by aerosolizing Infasurf at 35mg/ml at a rate of 1.8 to 2.2 mls per minute until therapeutic response is achieved or the maximum amount of a single dose is reached.
Time Frame
24 hours post PICU admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
Within 4 hours of PICU admission.
Exclusion Criteria:
Need for non-invasive BiPAP or invasive ventilation
Significant Co-morbidities
Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
Unrepaired congenital heart disease
Immune compromise
Neuromuscular weakness
Tracheostomy
Influenza as the etiologic agent of bronchiolitis
Inability to stabilize the infant to a bronchiolitis score < 8
Facility Information:
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
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