Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

The goal of this pragmatic clinical trial is to learn if the drug surfactant given by a less invasive technique works to treat respiratory distress in preterm infants in low- and middle-income African countries where invasive ventilators are unavailable. It will also learn about the safety of the less invasive surfactant administration (LISA) technique. The main questions it aims to answer are: Does surfactant given by a less invasive surfactant administration technique improve survival in preterm infants in low- and middle-income countries? What medical problems do participants have when receiving surfactant given by the less invasive surfactant administration technique? Researchers will implement the less invasive surfactant administration technique and see if it works to treat respiratory distress in preterm infants compared to preterm who did not receive surfactant. Participants with respiratory distress who are being treated with continuous positive airway pressure and caffeine citrate will: Receive surfactant replacement therapy by the less invasive surfactant administration technique. Be monitored for complications Be followed throughout their hospitalization to determine their survival rate.

NCT Number	NCT06554522
Lead Sponsor	Indiana University Collaborators: Coefficient Giving (Formerly Open Philanthropy)
Conditions	Respiratory Distress Syndrome in Premature Infant, RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Premature Birth
Enrollment	1,512 participants
Start Date	2025-01-01
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-27