Background: The management of respiratory distress syndrome (RDS) in premature newborns is based on different types of non-invasive respiratory support and on surfactant replacement therapy (SRT) to avoid mechanical ventilation as it may eventually result in lung damage. European guidelines currently recommend SRT only when the fraction of inspired oxygen (FiO2) exceeds 0.30. The literature describes that early SRT decreases the risk of bronchopulmonary dysplasia (BPD) and mortality. Lung ultrasound score (LUS) in preterm infants affected by RDS has proven to be able to predict the need for SRT and different single-center studies have shown that LUS may increase the proportion of infants that received early SRT. Therefore, the aim of this study is to determine if the use of LUS as a decision tool for SRT in preterm infants affected by RDS allows for the reduction of the incidence of BPD or death in the study group. Methods/design: In this study, 668 spontaneously-breathing preterm infants, born at 25+0 to 29+6 weeks’ gestation, in nasal continuous positive airway pressure (nCPAP) will be randomized to receive SRT only when the FiO2 cut-off exceeds 0.3 (control group) or if the LUS score is higher than 8 or the FiO2 requirements exceed 0.3 (study group) (334 infants per arm). The primary outcome will be the difference in proportion of infants with BPD or death in the study group managed compared to the control group. Discussion: Based on previous published studies, it seems that LUS may decrease the time to administer surfactant therapy. It is known that early surfactant administration decreases BPD and mortality. Therefore, there is rationale for hypothesizing a reduction in BPD or death in the group of patients in which the decision to administer exogenous surfactant is based on lung ultrasound scores. Trial registration: ClinicalTrials.gov identifier NCT05198375 . Registered on 20 January 2022.
Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) / Corsini, I.; Rodriguez-Fanjul, J.; Raimondi, F.; Boni, L.; Berardi, A.; Aldecoa-Bilbao, V.; Alonso-Ojembarrena, A.; Ancora, G.; Aversa, S.; Beghini, R.; Meseguer, N. B.; Capasso, L.; Chesi, F.; Ciarcia, M.; Concheiro, A.; Corvaglia, L.; Ficial, B.; Filippi, L.; Carballal, J. F.; Fusco, M.; Gatto, S.; Ginovart, G.; Gregorio-Hernandez, R.; Lista, G.; Sanchez-Luna, M.; Martini, S.; Massenzi, L.; Miselli, F.; Mercadante, D.; Mosca, F.; Palacio, M. T.; Perri, A.; Piano, F.; Prieto, M. P.; Fernandez, L. R.; Risso, F. M.; Savoia, M.; Staffler, A.; Vento, G.; Dani, C.. - In: TRIALS. - ISSN 1745-6215. - 24:1(2023), pp. 706-717. [10.1186/s13063-023-07745-8]
Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
Berardi A.;Ancora G.;Capasso L.;Filippi L.;Lista G.;Martini S.;Miselli F.;Mosca F.;Perri A.;
2023
Abstract
Background: The management of respiratory distress syndrome (RDS) in premature newborns is based on different types of non-invasive respiratory support and on surfactant replacement therapy (SRT) to avoid mechanical ventilation as it may eventually result in lung damage. European guidelines currently recommend SRT only when the fraction of inspired oxygen (FiO2) exceeds 0.30. The literature describes that early SRT decreases the risk of bronchopulmonary dysplasia (BPD) and mortality. Lung ultrasound score (LUS) in preterm infants affected by RDS has proven to be able to predict the need for SRT and different single-center studies have shown that LUS may increase the proportion of infants that received early SRT. Therefore, the aim of this study is to determine if the use of LUS as a decision tool for SRT in preterm infants affected by RDS allows for the reduction of the incidence of BPD or death in the study group. Methods/design: In this study, 668 spontaneously-breathing preterm infants, born at 25+0 to 29+6 weeks’ gestation, in nasal continuous positive airway pressure (nCPAP) will be randomized to receive SRT only when the FiO2 cut-off exceeds 0.3 (control group) or if the LUS score is higher than 8 or the FiO2 requirements exceed 0.3 (study group) (334 infants per arm). The primary outcome will be the difference in proportion of infants with BPD or death in the study group managed compared to the control group. Discussion: Based on previous published studies, it seems that LUS may decrease the time to administer surfactant therapy. It is known that early surfactant administration decreases BPD and mortality. Therefore, there is rationale for hypothesizing a reduction in BPD or death in the group of patients in which the decision to administer exogenous surfactant is based on lung ultrasound scores. Trial registration: ClinicalTrials.gov identifier NCT05198375 . Registered on 20 January 2022.
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2023 Lung Ultrasound Guided Surfactant Therapy Protocol.pdf
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