Morbidity and Predictors of Lethal Outcome in Premature Infants Who Received Poractant Alpha With Gestation Age of Less Than 32 Weeks

Abstract

The aim of the study – to analyze the morbidity and search for predictors of death in premature infants with a gestational age (GA) of 32 weeks or less, born in perinatal centers and received Poractant alfa (PA) in the treatment of respiratory distress syndrome (RDS), in order to improve the quality of medical care for premature babies. Materials and methods of research: a multicenter prospective open-label non-randomized continuous comparative study was conducted in five perinatal centers from 2020 to 2021. A total of 264 patients, and inclusion criteria: GA less than 32 weeks, the need for PA replacement therapy in the first minutes of life, the first dose of PA – 200 mg/kg, the second dose of PA – 100 mg/kg, strict adherence to the study protocol. Children who did not require PA therapy in the delivery room, who received other types of surfactants, as well as those with congenital malformations, genetic and/or chromosomal abnormalities, early neonatal sepsis, and deviations from the study protocol were excluded. Children were divided into 3 groups: group 1 (200 children) – invasive PA (ETT), group 2 (19 children) – PA injection by INSURE method, group 3 (45 children) – PA injection by LISA method. Results: the median birth weight of all 264 children was 1090.0 g, GA – 28.0 weeks. The median age of the first PA injection is 10.0 [10.0; 10.0] min of life. PA was reintroduced in 20.1% (53/264) of children, invasive mechanical ventilation (IV) was required in 82.6% (218/264) of cases, high-frequency oscillatory mechanical ventilation (HFOV) – in 24.0% (59/264 ). The incidence of bronchopulmonary dysplasia was 37.5% (99/264) of cases and prevailed in the ETT group in comparison with LISA (43.0% versus 27.0%, respectively, p=0.043) and INSURE (43.0% versus 5.0 %, p=0.001). Predictors of death were low gestational age and birth weight, surgical stage of necrotizing enterocolitis, hemodynamically significant patent ductus arteriosus, grade III intraventricular hemorrhage, and pulmonary hemorrhage. The development of the latter in the first 72 hours of life increases the risk of death by 19.7 times. Conclusions: minimally invasive administration of PA by INSURE and LISA methods associated with reduce of morbidity and improves outcomes in premature infants who less than 32 weeks of GA. Pulmonary hemorrhage was the most dangerous among the predictors of death, increasing the risk of death by almost 20 times.