Protocol for a multicenter, double-blind, randomized, placebo-controlled phase III trial of the inhaled β2-adrenergic receptor agonist salbutamol for transient tachypnea of the newborn (the REFSAL trial).

ABSTRACT:

Background

Transient tachypnea of the newborn (TTN), which results from inadequate absorption of fetal lung fluid, is the most common cause of neonatal respiratory distress. Stimulation of β-adrenergic receptors enhances alveolar fluid absorption. Therefore, the β2-adrenergic receptor agonist salbutamol has been proposed as a treatment for TTN. This study aims to evaluate the efficacy and safety of salbutamol as supportive pharmacotherapy together with non-invasive nasal continuous positive airway pressure (NIV/nCPAP) for the prevention of persistent pulmonary hypertension of the newborn (PPHN) in infants with TTN.

Methods and analysis

This multicenter, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks who are affected by respi

SUBMITTER: Madajczak D 

PROVIDER: S-EPMC9879660 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature