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the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
Sponsor: Medical University of Warsaw
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).
Official title: a Multicentre, Double-blind, Randomized, Placebo-controlled Phase III Trial of the Inhaled β2-adrenergic Receptor Agonist Salbutamol for Transient Tachypnoea of the Newborn (the REFSAL Trial)
Key Details
Gender
All
Age Range
Any - 24 Hours
Study Type
INTERVENTIONAL
Enrollment
608
Start Date
2021-12-31
Completion Date
2026-09-30
Last Updated
2025-11-18
Healthy Volunteers
No
Conditions
Interventions
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.
0,9% Chloride Sodium
3 mL nebulized 0.9% NaCl administered for 30 min.
Locations (1)
Medical University of Warsaw
Warsaw, Poland