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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Warsaw
• Collaborators: Jagiellonian University; Jan Biziel University Hospital No 2 in Bydgoszcz; Neonatology Unit, Specialist Hospital No 2, Bytom; Pomeranian Medical University Szczecin; Poznan University of Medical Sciences; University in Zielona Góra; University of Ottawa; University of Rzeszow
• Treatments: Albuterol

Criteria

Inclusion Criteria:

1. Gestational age at birth between 32 and 42 weeks.

2. Respiratory disorders (tachypnea and expiratory grunting) lasting longer than 15 minutes after birth, or present for at least 15 minutes in the first six hrs of life, or a need for non-invasive respiratory support between birth and six hrs of life.

3. Available chest radiographs obtained within six hrs after birth.

4. Available parameters of the acid-base balance (blood pH, partial pressure of O2 and CO2, base excess) and blood serum ionogram for Na+, K+, Ca2+ evaluated in the umbilical cord blood sample.

Exclusion Criteria:

1. Need for intubation directly after birth or perinatal asphyxia, defined as abnormal acid-base parameters detected in an umbilical cord blood sample (pH <7.0 or base excess < -14 mmol/L).

2. Multiple apnea-brady that require immediate intubation before a trial of NIV

3. Age >24 h.

4. Meconium aspiration syndrome.

5. Air leak syndrome.

6. Congenital heart disease.

7. Congenital diaphragmatic hernia.

8. Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure.

9. The need for a surfactant administration immediately after birth, regardless of the method of its administration (respiratory distress syndrome - RDS)