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

PHASE3RecruitingINTERVENTIONAL
Enrollment

608

Participants

Timeline

Start Date

December 31, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

September 30, 2026

Conditions
TTNRespiratory FailurePPHN
Interventions
DRUG

Salbutamol

Patients assigned to the active group will be treated with 0.15 mg/kg body weight (diluted in 3 mL 0.9% NaCl) nebulized salbutamol (Ventolin®, GlaxoSmithKline, Dublin, Ireland) for 30 min.

DRUG

0,9% Chloride Sodium

3 mL nebulized 0.9% NaCl administered for 30 min.

Trial Locations (1)

Unknown

RECRUITING

Medical University of Warsaw, Warsaw

All Listed Sponsors
collaborator

University of Ottawa

OTHER

collaborator

Jagiellonian University

OTHER

collaborator

Pomeranian Medical University Szczecin

OTHER

collaborator

Poznan University of Medical Sciences

OTHER

collaborator

Jan Biziel University Hospital No 2 in Bydgoszcz

OTHER

collaborator

Neonatology Unit, Specialist Hospital No 2, Bytom

UNKNOWN

collaborator

University of Rzeszow

OTHER

collaborator

University in Zielona Góra

OTHER

lead

Medical University of Warsaw

OTHER