NCT03748173

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: ONY · Industry
• Sex: All
• Age: 0 Months – 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-12
• Primary completion: 2020-10-02
• Completion: 2020-10-21
• First posted: 2018-11-20
• Last updated: 2020-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study