Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
Author:
Corsini IuriORCID, Rodriguez-Fanjul Javier, Raimondi Francesco, Boni Luca, Berardi Alberto, Aldecoa-Bilbao Victoria, Alonso-Ojembarrena Almudena, Ancora Gina, Aversa Salvatore, Beghini Renzo, Meseguer Nerea Bilbao, Capasso Letizia, Chesi Francesca, Ciarcià Martina, Concheiro Ana, Corvaglia Luigi, Ficial Benjamim, Filippi Luca, Carballal Jesus Fuentes, Fusco Monica, Gatto Sara, Ginovart Gemma, Gregorio-Hernández Rebeca, Lista Gianluca, Sánchez-Luna Manuel, Martini Silvia, Massenzi Luca, Miselli Francesca, Mercadante Domenica, Mosca Fabio, Palacio Marta Teresa, Perri Alessandro, Piano Francesca, Prieto Marcelino Pumarada, Fernandez Lorena Rodeno, Risso Francesco Maria, Savoia Marilena, Staffler Alex, Vento Giovanni, Dani Carlo
Abstract
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.
Funder
Chiesi Farmaceutici
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference25 articles.
1. Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, et al. European consensus guidelines on the management of respiratory distress syndrome: 2022 Update. Neonatology. 2023;120:3–23. 2. Bahadue FL, Soll R. Early versus delayed selective surfactant treatment for neonatal respiratory distress syndrome. Cochrane Database Syst Rev. 2012;104:124–6. 3. Raschetti R, Yousef N, Vigo G, Marseglia G, Centorrino R, Ben-Ammar R, et al. Echography-guided surfactant therapy to improve timeliness of surfactant replacement: a quality improvement project. J Pediatr. 2019;212:137-143.e1. 4. Rodriguez-Fanjul J, Jordan I, Balaguer M, Batista-Muñoz A, Ramon M, Bobillo-Perez S. Early surfactant replacement guided by lung ultrasound in preterm newborns with RDS: the ULTRASURF randomised controlled trial. Eur J Pediatr. 2020;179:1913–20. 5. Polin RA, Carlo WA, Papile LA, Tan R, Kumar P, Benitz W, et al. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014;133:156–63.
|
|