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

Conditions

• TTN
• Respiratory Failure
• PPHN

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.

Sponsors & Collaborators

• University of Ottawa

  collaborator OTHER

• Jagiellonian University

  collaborator OTHER

• Pomeranian Medical University Szczecin

  collaborator OTHER

• Poznan University of Medical Sciences

  collaborator OTHER

• Jan Biziel University Hospital No 2 in Bydgoszcz

  collaborator OTHER

• Neonatology Unit, Specialist Hospital No 2, Bytom

  collaborator UNKNOWN

• University of Rzeszow

  collaborator OTHER

• University in Zielona Góra

  collaborator OTHER

• SZPITAL SPECJALISTYCZNY IM. ŚW. RODZINY w Warszawie

  collaborator UNKNOWN

• Neonatology Unit, Szpital Specjalistyczny Pro-Familia, Rzeszow

  collaborator UNKNOWN

• Medical University of Warsaw

  lead OTHER

Principal Investigators

• Renata Bokiniec, MD, PhD · Medical University of Warsaw

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-31

Primary Completion

2025-11-30

Completion

2026-09-30

Countries

• Poland

Study Locations