| Autor: |
Iuri Corsini, Javier Rodriguez-Fanjul, Francesco Raimondi, Luca Boni, Alberto Berardi, Victoria Aldecoa-Bilbao, Almudena Alonso-Ojembarrena, Gina Ancora, Salvatore Aversa, Renzo Beghini, Nerea Bilbao Meseguer, Letizia Capasso, Francesca Chesi, Martina Ciarcià, Ana Concheiro, Luigi Corvaglia, Benjamim Ficial, Luca Filippi, Jesus Fuentes Carballal, Monica Fusco, Sara Gatto, Gemma Ginovart, Rebeca Gregorio-Hernández, Gianluca Lista, Manuel Sánchez-Luna, Silvia Martini, Luca Massenzi, Francesca Miselli, Domenica Mercadante, Fabio Mosca, Marta Teresa Palacio, Alessandro Perri, Francesca Piano, Marcelino Pumarada Prieto, Lorena Rodeno Fernandez, Francesco Maria Risso, Marilena Savoia, Alex Staffler, Giovanni Vento, Carlo Dani |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Trials, Vol 24, Iss 1, Pp 1-11 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
1745-6215 |
| DOI: |
10.1186/s13063-023-07745-8 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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