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ACTIVE NOT RECRUITING
NCT05527704
PHASE3

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

Sponsor: Medical University of Warsaw

View on ClinicalTrials.gov

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

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.

Locations (1)

Medical University of Warsaw

Warsaw, Poland