InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age29-36
SponsorONY
About 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.
Eligibility criteria
Qualifiers
Written informed consent obtained by parent or legal representative prior to or after birth
Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
Birthweight ≥ 1,000 AND ≤ 3,500 grams
Age ≥ 1 hour AND ≤ 6 hours
Disqualifiers
Surfactant administration prior to randomization
Mechanical ventilation prior to randomization
Major congenital anomaly (suspected or confirmed)
Abnormality of the airway (suspected or confirmed)
Trial design
Treatments tested in this trial
- Infasurf Aero™
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
ONY
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov