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Comparison of “IN-REC-SUR-E” and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial)

2024; Springer Science+Business Media; Volume: 25; Issue: 1 Linguagem: Inglês

10.1186/s13063-024-08240-4

1745-6215

Giovanni Vento, A Paladini, Claudia Aurilia, S. Alkan Ozdemir, Virgilio Carnielli, Filip Cools, Simonetta Costa, Francesco Cota, Carlo Dani, Peter G. Davis, Simona Fattore, Candel Arenas María Fe, Neil Finer, Francesca Paola Fusco, Camilla Gizzi, Egbert Herting, Min Jian, Alessandra Lio, Gianluca Lista, Fabio Mosca, Stefano Nobile, Alessandro Perri, Simonetta Picone, J. Jane Pillow, Graeme R. Polglase, Tina Pasciuto, Roberta Pastorino, Milena Tana, David G. Tingay, Chiara Tirone, Anton H. van Kaam, Maria Luisa Ventura, Arianna Aceti, Massimo Agosti, Giovanni Alighieri, Gina Ancora, V. Angileri, Gaetano Ausanio, Salvatore Aversa, Eleonora Balestri, Eugenio Baraldi, Maria Cristina Barbini, C. Barone, Renzo Beghini, Cristina Bellan, Alberto Berardi, Ilaria Di Bernardo, Pasqua Betta, Marco Binotti, Barbara Bizzarri, Gabriella Borgarello, S Borgione, Angela Carla Borrelli, Rita Bottino, Giorgia Bracaglia, Ilia Bresesti, Ilaria Burattini, Caterina Cacace, Francesca Calzolari, Maria Francesca Campagnoli, Letizia Capasso, Manuela Capozza, Maria Grazia Capretti, Jacopo Caravetta, Caterina Carbonara, Viviana Cardilli, Maurizio Carta, Francesca Castoldi, Antonella Castronovo, E. Cavalleri, Francesco Cavigioli, Stefano Cecchi, V. Chierici, C. Cimino, Francesco Cocca, Carmen Cocca, Paola Cogo, Mar Iglesias Coma, V. Comito, V. Condò, Chiara Consigli, Rossella Conti, Massimiliano Corradi, Giovanni Corsello, Luigi Corvaglia, A. Costa, Alessandra Coscia, Francesco Cresi, Federica Crispino, Paolo D’Amico, Lucrezia De Cosmo, C. De Maio, Giovanni Campo, S. Di Credico, Sandra Di Fabio, Paola Di Nicola, Ambrogio Di Paolo, S. Di Valerio, Antonietta Distilo, Vincenzo Duca, Alfredo Falcone, Raffaele Falsaperla, Valeria Fasolato, Valentina Fatuzzo, Francesca Favini, Maria Pia Ferrarello, Stefania Ferrari, Federico Fiori Nastro, Carlo Alberto Forcellini, Annalisa Fracchiolla, A. Gabriele, Francesca Galdo, Francesca Gallini, Antonio Gangemi, G Gargano, Diego Gazzolo, Maria Paola Gentile, Stefano Ghirardello, Federica Giardina, Lucio Giordano, Eloisa Gitto, Mario Giuffrè, Lidia Grappone, Fiorentino Grasso, I. Greco, Alessandra Grison, Roberta Guglielmino, Isotta Guidotti, Isabella Guzzo, Nicola La Forgia, Simona La Placa, Giuseppe La Torre, Paola Lago, Lucia Lanciotti, Anna Lavizzari, Francesco Leo, Valentina Leonardi, D. Lestingi, J Li, P Liberatore, Daud Lodin, Riccardo Lubrano, Maria Stella Lucente, Stefano Luciani, Dimenica Luvarà, G Maffei, Aurelio Maggio, Luca Maggio, Kim Maiolo, Laura Malaigia, Giovanna Mangili, Alessio La Manna, Eugenia Maranella, Antonia Marcianò, Paola Marcozzi, M Marletta, Lucia Marseglia, Domenico Martinelli, Stefano Martinelli, Serafina Massari, Luca Massenzi, Federico Matina, Lorenza Mattia, G. Mescoli, Ignazia Valentina Migliore, Diego Minghetti, Isabella Mondello, Silvia M. Montano, Grazia Morandi, Nadia Mores, S. Morreale, I Morselli, Marina Motta, Marcello Napolitano, Daniel Nardo, Aessandra Nicolardi, Silvia Nider, Gerardo Nigro, Melissa Maria Nuccio, Luigi Orfeo, C Ottaviano, Paola Paganin, Sabrina Palamides, Sara Palatta, Piermichele Paolillo, Maria Grazia Pappalardo, Elisa Pasta, L. Patti, Giulia Paviotti, Roberto Perniola, Gianfranco Perotti, Serafina Perrone, Francesca De Petrillo, Maria Santa Piazza, Alessandro Piccirillo, Maria Pierro, Emily Piga, G. Pingitore, S Pisu, Carla Pittini, F Pontiggia, Giovanni Pontrelli, A. Primavera, Alice Proto, Lorenzo Quartulli, Francesco Raimondi, Luca A. Ramenghi, Maria Anna Rapsomaniki, Alberto Ricotti, Christophe Rigotti, Matteo Rinaldi, Francesco Maria Risso, Elisabetta Roma, Enzo Romanini, Valerio Romano, E Rosati, Vincenzo Rosella, Immacolata Rulli, Vincenzo Salvo, Cinzia Sanfilippo, A. Sannia, Andrea Saporito, Alessandra Sauna, E. Scapillati, F Schettini, Antonio Scorrano, Simona Semeria Mantelli, Vittoria Sepporta, Paola Sindico, Annalisa Solinas, Elena Sorrentino, Emmanuel Spaggiari, Alex Staffler, Marcello Stella, Donatella Termini, Gianluca Terrin, A. C. Testa, Gabriella Lucia Tina, Massimo Tirantello, Barbara Tomasini, Francesca Tormena, Laura Travan, Daniele Trevisanuto, G. Tuling, Viviana Tulino, L Valenzano, Stefania Vedovato, Silvia Vendramin, P. Villani, S Viola, Veronica Viola, Giuliana Vitaliti, Marcello Vitaliti, Petra Wanker, Yi Yang, Sara Zanetta, Emanuela Zannin,

Congenital Diaphragmatic Hernia Studies

Abstract Background Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. Methods In this study, 382 infants born at 24 +0 –27 +6 weeks’ gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks’ postmenstrual age. The secondary outcomes are BPD at 36 weeks’ postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24 +0 to 25 +6 weeks or 26 +0 to 27 +6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). Discussion This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24 +0 –27 +6 weeks’ gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks’ postmenstrual age of life. Trial registration ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.