Prophylactic Minimally Invasive Surfactant Evaluation

ConditionsRespiratory Distress Syndrome, Newborn Premature Birth

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

Qualifiers

Gestational age <30 weeks

Antenatal consent from Parent

Disqualifiers

Congenital anomalies

Alternate cause of respiratory distress

Trial design

Treatments tested in this trial

Poractant Alfa

Treatment groups

200 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Endeavor Health

Lead sponsor

Chiesi USA, Inc.

Collaborator

Source ClinicalTrials.gov