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

NCT ID: NCT03748173

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-12
• Study Completion Date: 2020-10-21

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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.

Group Type: EXPERIMENTAL

Aerosolized Infasurf

Intervention Type: COMBINATION_PRODUCT

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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Calfactant

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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ONY

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Countries

United States

Other Identifiers

Aero-04

Identifier Type: -

Identifier Source: org_study_id