Prophylactic Minimally Invasive Surfactant Evaluation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 15
SponsorEndeavor Health
About this trial
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Gestational age <30 weeks
Antenatal consent from Parent
Disqualifiers
Congenital anomalies
Alternate cause of respiratory distress
Trial design
Design model
Parallel
Treatments tested in this trial
Poractant Alfa
DrugPoractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Prophylactic Surfactant via Minimally Invasive TechniqueExperimental treatment 1 intervention
Group B: Rescue Surfactant via Minimally Invasive TechniqueActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Endotracheal Intubation
Oxygen requirement \> 45% requiring endotracheal intubation
Time frame
7 daysSecondary outcomes
1
Bronchopulmonary dysplasia
Oxygen requirement to 36 weeks corrected age
Time frame
36 weeks corrected gestational ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Endeavor Health
Lead sponsor
Chiesi USA, Inc.
Collaborator
Source ClinicalTrials.gov