Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
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|ClinicalTrials.gov Identifier: NCT03748173|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Combination Product: Aerosolized Infasurf||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants|
|Actual Study Start Date :||January 12, 2019|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||March 30, 2020|
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.
Combination Product: Aerosolized Infasurf
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.
Other Name: Calfactant
No Intervention: Usual Care
The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®.
- Improvement in Respiratory Status [ Time Frame: 24 hours post PICU admission ]Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.
- Need of Respiratory support [ Time Frame: 24 hours post PICU admission ]Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation
- Dose as Measured as duration of the therapy [ Time Frame: 24 hours post PICU admission ]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.
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): NCT03748173
|Contact: corey firstname.lastname@example.org|
|Contact: Dan Swartzemail@example.com|
|United States, Virginia|
|Children's Hospital of Richmond at VCU||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Doug Willson, MD 804-828-4529 firstname.lastname@example.org|
|Principal Investigator: Doug Willson, MD|