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

Respiratory Failure Clinical Trial

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)

Clinical Trial 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).

Clinical Trial Description

Multicentre, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks and respiratory disorders treated in neonatal intensive care units in Poland. Infants will be enrolled no later than 24 h after birth and will be randomly assigned (1:1) to receive nebulized salbutamol with nCPAP or placebo (nebulized 0.9% NaCl) with nCPAP. The primary outcome is the percentage of infants with TTN who develop PPHN. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05527704
Study type Interventional
Source Medical University of Warsaw
Contact Renata Bokiniec, MD, PhD, Assoc Prof
Phone +48225966155
Email renata.bokiniec@wum.edu.pl
Status Recruiting
Phase Phase 3
Start date December 31, 2021
Completion date September 30, 2026
View Details
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