Bronchiolitis
Conditions
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 1. Do bronchiolitis patients tolerate aerosolized Infasurf? 2. Does aerosolized Infasurf induce an improvement in respiration? 3. If it does how large a dose is required to observe a positive effect? 4. Is the positive effect transient, if so what is the range of duration of the effect? 5. Does retreatment also result and a positive response? 6. Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.
Interventions
COMBINATION_PRODUCTAerosolized 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.
Sponsors
ONY
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 4 Months
Healthy volunteers
No
Inclusion criteria
1. Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis 2. Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support 3. Within 4 hours of PICU admission.
Exclusion criteria
1. Need for non-invasive BiPAP or invasive ventilation 2. Significant Co-morbidities 1. Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD) 2. Unrepaired congenital heart disease 3. Immune compromise 4. Neuromuscular weakness 3. Tracheostomy 4. Influenza as the etiologic agent of bronchiolitis 5. Inability to stabilize the infant to a bronchiolitis score \< 8
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Respiratory Status | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need of Respiratory support | 24 hours post PICU admission | Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dose as Measured as duration of the therapy | 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. |
Countries
United States
Outcome results
None listed