Inhaled salbutamol for treating newborns with transient tachypnoea

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)

This study is testing if inhaled salbutamol can help newborns with breathing problems feel better and avoid serious complications like persistent pulmonary hypertension.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 608 (estimated)
• Ages: N/A to 24 Hours
• Sex: All
• Sponsor: Medical University of Warsaw (other)
• Locations: 1 site (Warsaw)
• Trial ID: NCT05527704 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of nebulized salbutamol in neonates with transient tachypnoea of the newborn (TTN) who are receiving non-invasive respiratory support. The multicentre, double-blind, phase III trial will enroll infants with a gestational age between 32 and 42 weeks and respiratory disorders, assigning them randomly to receive either salbutamol or a placebo. The primary outcome is to assess the percentage of infants with TTN who subsequently develop persistent pulmonary hypertension of the newborn (PPHN). The trial aims to provide insights into the potential benefits of salbutamol in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are neonates with a gestational age between 32 and 42 weeks who exhibit respiratory disorders shortly after birth.

Not a fit: Patients who require immediate intubation or have severe congenital conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve respiratory outcomes for newborns suffering from transient tachypnoea.

How similar studies have performed: Other studies have explored similar interventions, but this specific approach with salbutamol in this population is relatively novel.

Eligibility 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)

Where this trial is running

Warsaw

• Medical University of Warsaw — Warsaw, Poland (RECRUITING)

Study contacts

• Principal investigator: Renata Bokiniec, MD, PhD — Medical University of Warsaw
• Study coordinator: Renata Bokiniec, MD, PhD, Assoc Prof

Conditions: TTN, Respiratory Failure, PPHN, CPAP, Salbutamol