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

Study acronym: REFSAL
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborators: 8 to 10
    v5
  2. Interventions: 0,9% Chloride Sodium (Drug), salbutamol (Drug) to 0,9% Chloride Sodium (Drug), Salbutamol (Drug)v4
  3. Primary completion date: Dec 31, 2023 to Nov 30, 2025
    • Study completion date: Dec 31, 2024 to Sep 30, 2026
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
(from sponsor)		 TTN, Respiratory Failure, PPHN
Related terms Respiratory Insufficiency
Enrollment 608 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov