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

Phase 3 Active not recruiting 608 enrolled Medical University of Warsaw Jagiellonian University · collab Jan Biziel University Hospital No 2 in Bydgoszcz · collab Neonatology Unit, Specialist Hospital No 2, Bytom · collab Neonatology Unit, Szpital Specjalistyczny Pro-Familia, Rzeszow · collab Pomeranian Medical University Szczecin · collab Poznan University of Medical Sciences · collab SZPITAL SPECJALISTYCZNY IM. ŚW. RODZINY w Warszawie · collab University in Zielona Góra · collab University of Ottawa · collab University of Rzeszow · collab

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2021-12-31
Primary completion: 2025-11-30
Completion: 2026-09-30

Publications

Madajczak D, Daboval T, Lauterbach R, Loniewska B, Blaz W, Szczapa T, Sadowska-Krawczenko I, Michalak-Kloc M, Slawska H, Borszewska-Kornacka M, Bokiniec R; REFSAL Study Group. Protocol for a multicenter, double-blind, randomized, placebo-controlled phase III trial of the inhaled beta2-adrenergic receptor agonist salbutamol for transient tachypnea of the newborn (the REFSAL trial). Front Pediatr. 2023 Jan 12;10:1060843. doi: 10.3389/fped.2022.1060843. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Salbutamol	Unknown	0.15 mg/kg	Inhaled

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

Summary

Timeline

Publications

Drugs

Indications