Infasurf Aero™ for Neonatal Respiratory Distress Syndrome
(Aero-05 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
Is Infasurf Aero™ safe for use in humans?
How is the drug Infasurf Aero™ different from other treatments for neonatal respiratory distress syndrome?
What is the purpose of this trial?
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
Research Team
Scott Guthrie, MD
Principal Investigator
Vanderbilt Jackson-Madison, Jackson TN
Dinushan Kaluarachchi, MD
Principal Investigator
Unity Point Meriter, Madison WI
Jim Cummings, MD
Principal Investigator
Ony Biotech
Eligibility Criteria
This trial is for preterm newborns with a clinical diagnosis of surfactant-deficient RDS, needing non-invasive respiratory support, and weighing between 1,000 to 3,500 grams. They should be born at a gestational age of 29 to almost 37 weeks and are between 1 to 6 hours old. Newborns with airway abnormalities, prior mechanical ventilation or surfactant treatment, severe birth complications or major congenital anomalies cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
A single dose of Calfactant at 6ml/kg administered via the Infasurf Aero™ Nebulizer or sham treatment with respiratory air alone
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of CPAP failure and other respiratory outcomes
Treatment Details
Interventions
- InfasurfAero™
Find a Clinic Near You
Who Is Running the Clinical Trial?
ONY
Lead Sponsor
Avania
Industry Sponsor