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

Stopped early · Phase 1

Conditions studied: Bronchiolitis

In brief

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.

Key facts

Study ID

NCT03748173

Run by

ONY

People needed

13

Starts

2019-01-12

Expected to finish

2020-10-21

Last updated by the study team

2020-10-23

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
• Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
• Within 4 hours of PICU admission.

You may not qualify if…

• Need for non-invasive BiPAP or invasive ventilation
• Significant Co-morbidities
• Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
• Unrepaired congenital heart disease
• Immune compromise
• Neuromuscular weakness
• Tracheostomy
• Influenza as the etiologic agent of bronchiolitis
• Inability to stabilize the infant to a bronchiolitis score < 8

Where it is running

• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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