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

ONY

Status and phase: Terminated; Phase 1

Conditions: Bronchiolitis

Treatments: Combination Product: Aerosolized Infasurf

Study type: Interventional

Funder types: Industry

Identifiers

NCT03748173

Aero-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Combination Product: Aerosolized Infasurf

Usual Care

No Intervention group

Description:

The only difference in care between treatment and usual care will be treatment with up to two doses of aerosolized Infasurf®.