At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 477 enrolled
Drug / intervention
Aerosolized Calfactant +1 moredrug
Likely dose
Aerosolized Calfactant 6mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
In Brief
A Phase 3 clinical trial evaluating Aerosolized Calfactant and Solarys for Respiratory Distress Syndrome. Completed, enrolled 477 participants across 22 sites.
Detailed Summary
Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Distress Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartMar 2017
Primary CompletionJun 2018
Study CompletionJul 2018
TodayJul 2026
First PostedFeb 23, 2017
Enrollment StartMar 29, 2017
Primary CompletionJun 1, 2018
Study CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.4 years ago
Interventions
Aerosolized Calfactantdrug
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
Solarysdevice
Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.