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

Phase 1TerminatedNCT03748173

ONY13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchiolitis

Interventions

Aerosolized InfasurfCOMBINATION_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.

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 4 Months

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Improvement in Respiratory Status

Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to ≤4.

Time frame: 24 hours post PICU admission

Secondary Outcomes

Need of Respiratory support

Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation

Time frame: 24 hours post PICU admission

Data from ClinicalTrials.gov

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