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Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa

StatusRecruiting
PhasePhase 4
Started2025-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-03-23
minor
Study Status, Sponsor/Collaborators v5
Re-verified, no change to tracked fields
2025-04-04
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-02-01→confirmed 2025-01-01
Study sitesdetails revised at 8 of 8 sites
2025-01-22
minor
Study Status, Contacts/Locations v3
Study sites8 entries, revised
ComplexeTamale HospitalierTeaching Universitaire Pédiatrique de BanguiHospital
2024-12-20
minor
Study Status v2
Start date2024-10-01→2025-02-01
2024-09-16
minor
Study Status, Contacts/Locations v1
Study sites8 entries, revised
KilifiCoast CountyGeneral Teaching & Referral Hospital
2024-08-13
minor
Original filing
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.
Trial Details
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