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

Phase 1

Terminated

• Conditions: Bronchiolitis
• Interventions: Combination Product: Aerosolized Infasurf

• Registration Number: NCT03748173
• Lead Sponsor: ONY

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.

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-20
• Study Start: 2019-01-12
• Status Verified: 2020-10
• Primary Completion: 2020-10-02
• Study Completion: 2020-10-21
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Aerosolized Infasurf	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Need of Respiratory support	24 hours post PICU admission	Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation

Trial Locations

Locations (1)

Children's Hospital of Richmond at VCU; 🇺🇸 Richmond, Virginia, United States