Researchers look for ways to prevent respiratory failure and pulmonary hypertension in newborns

Respiratory failure of newborns at birth is one of the most serious problems in modern neonatology. Thanks to improvements in the quality of perinatal care in Poland, for several years we have seen a slight decrease in the percentage of newborns born prematurely. On the other hand, the number of deliveries by cesarean section - both for elective indications and preceded by an attempted natural childbirth - has been increasing for several years. Currently, in some centers, the percentage of cesarean sections has already exceeded 50%.

- In the case of delivery by cesarean section in newborns due to impaired adaptation to ectopic life, we have to deal with impaired absorption of pulmonary fluid, the backlog of which in the lungs is the cause of a number of adverse phenomena, with the occurrence of respiratory failure and thus deterioration of the general condition of the newborn. Our project is dedicated to newborns who have completed 32 weeks of intrauterine life," explains Renata Bokiniec, MD, principal investigator in the REFSAL trial project

TTN - Transient Rapid Breathing of the Newborn (TTN) is one of the most common causes of respiratory failure among newborns born at term and so-called late preterm infants. Currently, there is a lack of strong data supporting the routine use of additional medications to treat respiratory distress in newborns (TTN). Some experts suggest that the early use of expansion pressures (e.g., early intranasal CPAP) along with inhaled salbutamol may alleviate the course of more severe forms of TTN and avoid the use of mechanical ventilation, which may consequently prevent the development of persistent pulmonary hypertension (PPHN). However, the authors of a 2016 meta-analysis of studies from the Cochrane database did not find a clear answer to the question of whether inhaled salbumatol will prevent or alleviate the course of more severe forms of TTN.

Researchers from Warsaw Medical University will conduct the Refsal multicenter study "A multicenter, double-blind, randomized, placebo-controlled phase III trial of the inhaled β2-adrenergic receptor agonist salbutamol for transient tachypnea of the newborn (the REFSAL trial) evaluating the efficacy and safety of inhaled salbutamol. It should be emphasized that salbutamol is a very well-studied drug that has applications in the treatment of asthma. The study will test other possibilities for its use in Neonatology. The study is funded by the Medical Research Agency.

- The primary goal of our study is to reduce (thanks to the intervention used - i.e., administration of the drug -salbutamol) the rate of severe pulmonary hypertension, which can be a complication of prolonged respiratory distress called TTN especially in babies born by cesarean section, explains Renata Bokiniec, MD, principal investigator in the REFSAL trial project

Any newborn whose respiratory distress persists after birth may be eligible for the study as long as there are no additional congenital abnormalities. - In order to include a newborn in the study, we initially ask both parents to give informed consent for their child to participate in the study. After the parents sign the informed consent , the newborn is assigned a study participant number through a special system called CRFem, after which we can proceed with the individual procedures," adds Renata Bokiniec, MD, principal investigator in the REFSAL trial project

Each newborn qualified for the study has a thorough echocardiogram of the heart, and ultrasound of the lungs. After these examinations, the patient is given an inhalation of a drug or saline, which lasts 30 minutes.

Source: ABM