Clinical Trial

the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)

Study acronym: REFSAL
Active, Not Recruiting Phase 3
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Record status
This record was last updated November 18, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Clinical trial evaluating the efficacy and safety of salbutamol for the treatment of neonates with a gestational age between 32 and 42 weeks with transient tachypnoea of the newborn (TTN).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-08-31; most recent amendment 2025-11-14.
Status change: Recruiting → Active, Not Recruiting 2025-11-14
Trial Details
NCT Number NCT05527704
Lead Sponsor Medical University of Warsaw
Collaborators: University of Ottawa, Jagiellonian University, Pomeranian Medical University Szczecin, Poznan University of Medical Sciences, Jan Biziel University Hospital No 2 in Bydgoszcz, Neonatology Unit, Specialist Hospital No 2, Bytom, University of Rzeszow, University in Zielona Góra, SZPITAL SPECJALISTYCZNY IM. ŚW. RODZINY w Warszawie, Neonatology Unit, Szpital Specjalistyczny Pro-Familia, Rzeszow
Conditions TTN, Respiratory Failure, PPHN
Enrollment 608 participants
Start Date 2021-12-31
Primary Completion 2025-11-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-18