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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
608
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.
3 mL nebulized 0.9% NaCl administered for 30 min.
Medical University of Warsaw
Warsaw, Poland
Persistent Pulmonary Hypertension of the Newborn (PPHN)
PPHN defined as the need for ventilation with FiO2 \>0.30 and features of increased pulmonary pressure on echocardiogram
Time frame: 7 days of life
the severity of respiratory distress
assessed with the modified TTN Silverman score
Time frame: 48 hrs of life
need for intubation
frequency of need for intubation
Time frame: 7 days of life
duration of ventilation
duration of ventilation e.g. non-invasive ventilation
Time frame: 7 days of life
duration of hospitalization
duration of hospitalisation after birth
Time frame: up to first month of life
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