Assessment of the frequency of persistent pulmonary hypertension of newborns in the group of newborns born between 32nd and 42th week of pregnancy treated with salbutamol

The primary objective of the clinical trial will be to assess the frequency of PPHN (persistent pulmonary hypertension of the newborn) defined as the need for ventilation with FiO2> 0.50 and the echocardiographic features of increased pulmonary pressure (right-left or bidirectional shunt through the patent ductus arteriosus) or the need for ventilation with FiO2> 0.50 and the difference in pre- and ductal saturation> 20%) in the treatment of respiratory failure in the group of newborns born between 32 and 41 weeks of pregnancy.

Secondary objectives will be to evaluate in the modified Silverman scale, hereinafter referred to as the "TTN scale" compared to the oxygen concentration used during ventilation and the intervention applied, and to evaluate the parameters of the acid-base balance test: pH, carbon dioxide pressure (pCO2), alkaline deficiency (BE) in compared groups. The study was designed as a prospective, multicentre, randomized, double-blind, placebo-controlled study.

In the study, we want to assess whether the additional administration of Salbutamol shortens the treatment time of a newborn with temporary breathing disorders. After the echocardiographic heart examination is performed, we will know if the newborn has persistent pulmonary hypertension and, using appropriate scales, including the Silverman scale, we will assess the advancement of respiratory disorders. The drug will be administered to the sick newborn for 6 hours, but for a maximum of 72 hours. The study will be performed in eight centres in Poland (Warsaw, Szczecin, Krakow, Poznan, Zielona Gora, Bydgoszcz, Rzeszów, Bytom) under the supervision of outstanding specialists.

We have also invited experts from Canada to participate in the study. We have adopted a hypothesis that the expected effect of the study will be the result according to which Salbutamol administered in nebulisation in respiratory insufficient newborns will reduce the incidence of PPHN, and at the same time will shorten the time of treatment, staying in incubator, separation with mother and frequency of severe complications. We are planning to include in the study a few hundred newborns.

General awarded funds FOR ALL: PLN 14,814,484

General awarded funds MUW ONLY: 3,868,672.5

"Research, Project number 2019/ABM/01/00058”, financed by the Medical Research Agency, Poland”