the Inhaled β2-adrenergic Receptor Agonist for Transient Tachypnoea of the Newborn (the REFSAL Trial)
- Conditions
- PPHNTTNRespiratory Failure
- Interventions
- Drug: 0,9% Chloride Sodium
- Registration Number
- NCT05527704
- Lead Sponsor
- Medical University of Warsaw
- Brief 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).
- Detailed Description
Multicentre, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks and respiratory disorders treated in neonatal intensive care units in Poland. Infants will be enrolled no later than 24 h after birth and will be randomly assigned (1:1) to receive nebulized salbutamol with nCPAP or placebo (nebulized 0.9% NaCl) with nCPAP. The primary outcome is the percentage of infants with TTN who develop PPHN.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 608
- Gestational age at birth between 32 and 42 weeks.
- 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.
- Available chest radiographs obtained within six hrs after birth.
- 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.
- 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).
- Multiple apnea-brady that require immediate intubation before a trial of NIV
- Age >24 h.
- Meconium aspiration syndrome.
- Air leak syndrome.
- Congenital heart disease.
- Congenital diaphragmatic hernia.
- Other severe congenital malformations and genetic disorders (diagnosed before and after birth) associated with increased risk of respiratory failure.
- The need for a surfactant administration immediately after birth, regardless of the method of its administration (respiratory distress syndrome - RDS)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPAP+Placebo 0,9% Chloride Sodium Patients in the placebo group will also receive nCPAP at 5-6 cm H2O pressure with an oxygen concentration of 21% or more to maintain preductal saturation between 90% and 95%. In addition, patients will receive 3 mL nebulised 0.9% NaCl administered for 30 min. as a placebo CPAP+Salbutamol Salbutamol All patients will receive nCPAP at 5-6 cm H2O pressure with an oxygen concentration of 21% or more to maintain preductal saturation between 90% and 95%. Patients assigned to the active group will be treated with 0.15 mg/kg body weight (diluted in 3 mL 0.9% NaCl) nebulised salbutamol (Ventolin®, GlaxoSmithKline, Dublin, Ireland) for 30 min.
- Primary Outcome Measures
Name Time Method Persistent Pulmonary Hypertension of the Newborn (PPHN) 7 days of life PPHN defined as the need for ventilation with FiO2 \>0.30 and features of increased pulmonary pressure on echocardiogram
- Secondary Outcome Measures
Name Time Method duration of ventilation 7 days of life duration of ventilation e.g. non-invasive ventilation
the severity of respiratory distress 48 hrs of life assessed with the modified TTN Silverman score
need for intubation 7 days of life frequency of need for intubation
duration of hospitalization up to first month of life duration of hospitalisation after birth
Trial Locations
- Locations (1)
Medical University of Warsaw
🇵🇱Warsaw, Poland