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

Launched by ONY · Nov 19, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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