Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
|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: NCT03748173|
Recruitment Status : Terminated (slowdown due to covid)
First Posted : November 20, 2018
Last Update Posted : October 23, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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)|
|Actual Enrollment :||13 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|
|Actual Primary Completion Date :||October 2, 2020|
|Actual Study Completion Date :||October 21, 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||0 Months to 4 Months (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Need for non-invasive BiPAP or invasive ventilation
- Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
- Unrepaired congenital heart disease
- Immune compromise
- Neuromuscular weakness
- Influenza as the etiologic agent of bronchiolitis
- Inability to stabilize the infant to a bronchiolitis score < 8
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
|United States, Virginia|
|Children's Hospital of Richmond at VCU|
|Richmond, Virginia, United States, 23298|
|Other Study ID Numbers:||
|First Posted:||November 20, 2018 Key Record Dates|
|Last Update Posted:||October 23, 2020|
|Last Verified:||October 2020|
|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:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory System Agents