Non Inferiority Trial Investigating Surfactants Administered Via MIST

Launched by ENDEAVOR HEALTH · Sep 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver surfactants, which are medications that help treat respiratory distress syndrome (RDS) in preterm infants. RDS is a condition where babies have trouble breathing because their lungs are not fully developed. The trial will compare two types of surfactants, Curosurf and Infasurf, given through a method called MIST (medication inhalation via a small tube) to see if this method is as effective as traditional delivery methods.

To be eligible for the trial, babies must be preterm, born between 28 and 35 weeks of gestation, and less than 48 hours old with a confirmed diagnosis of RDS. Infants who have other health issues or need immediate breathing support through intubation will not be included. Before joining the study, parents will need to give their consent. If your baby qualifies and participates, they will receive either Curosurf or Infasurf through the MIST method while being closely monitored by doctors and nurses. This research aims to find better ways to help preterm infants breathe easier and improve their health outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30
• Exclusion Criteria:
• • Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
• • Infants who require emergent intubation will not be enrolled in the interventions.