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

Launched by MEDICAL UNIVERSITY OF WARSAW · Aug 31, 2022

Keywords

ClinConnect Summary

The REFSAL Trial is a clinical study looking at the safety and effectiveness of a medication called salbutamol for treating newborns who have a condition known as transient tachypnoea of the newborn (TTN). TTN is a common breathing issue that can occur shortly after birth, especially in babies born between 32 and 42 weeks of pregnancy. The trial is currently recruiting participants and is open to all newborns up to 1 year old who show signs of breathing difficulties, such as fast breathing or grunting, for more than 15 minutes after birth.

To be eligible for the trial, babies need to have been born within the specified gestational age and have certain breathing problems that may require some support. However, those with more serious conditions like severe respiratory distress, congenital heart problems, or other significant health issues won't be included. If a baby participates, their caregivers can expect regular monitoring and support as the research team assesses how well the salbutamol works in helping with breathing difficulties. This trial aims to find better treatments for TTN and improve care for newborns facing respiratory challenges.

Gender

ALL

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)