Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04

Study Overview
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Brief Summary
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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
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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.

Official Title
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Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants

Conditions
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Bronchiolitis

Intervention / Treatment
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* Combination Product: Aerosolized Infasurf


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* 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.<br>* Other names: Calfactant;|
| No Intervention: Usual Care<br>The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Respiratory Status | Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4. | 24 hours post PICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of Respiratory support | Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation | 24 hours post PICU admission |