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

Giovanni Vento, Angela Paladini, Claudia Aurilia, S Alkan Ozdemir, V P Carnielli, F Cools, Simonetta Costa, Francesco Cota, C Dani, P G Davis, S Fattore, C Fè, N Finer, Francesca Paola Fusco, C Gizzi, E Herting, M Jian, Alessandra Lio, Gianluca Lista, F MoscaStefano Nobile, Alessandro Perri, S Picone, J J Pillow, G Polglase, Tina Pasciuto, Roberta Pastorino, Milena Tana, D Tingay, Chiara Tirone, A H van Kaam, M L Ventura, A Aceti, M Agosti, G Alighieri, G Ancora, V Angileri, G Ausanio, S Aversa, E Balestri, E Baraldi, M C Barbini, C Barone, Renzo Beghini, C Bellan, A Berardi, I Bernardo, P Betta, M Binotti, B Bizzarri, G Borgarello, S Borgione, A Borrelli, R Bottino, G Bracaglia, I Bresesti, I Burattini, C Cacace, F Calzolari, M F Campagnoli, L Capasso, M Capozza, M G Capretti, J Caravetta, C Carbonara, V Cardilli, M Carta, Filippo Castoldi, A Castronovo, E Cavalleri, F Cavigioli, S Cecchi, V Chierici, C Cimino, F Cocca, C Cocca, P Cogo, M Coma, V Comito, V Condò, C Consigli, R Conti, Mario Corradi, G Corsello, L T Corvaglia, Giovanni Alfio Costa, Alessandro Coscia, F Cresi, F Crispino, P D'Amico, L De Cosmo, C De Maio, G Del Campo, S Di Credico, S Di Fabio, P Di Nicola, A Di Paolo, S Di Valerio, A Distilo, V Duca, A Falcone, R Falsaperla, V A Fasolato, V Fatuzzo, F Favini, M P Ferrarello, S Ferrari, F Fiori Nastro, C A Forcellini, A Fracchiolla, A Gabriele, F Galdo, Francesca Gallini, A Gangemi, Gabriele Gargano, D Gazzolo, M P Gentile, S Ghirardello, F Giardina, Lucia Giordano, E Gitto, M Giuffrè, L Grappone, F Grasso, I Greco, A Grison, R Guglielmino, I Guidotti, Isabella Guzzo, N La Forgia, S La Placa, G La Torre, P Lago, L Lanciotti, A Lavizzari, F Leo, V Leonardi, D Lestingi, J Li, P Liberatore, D Lodin, R Lubrano, Monica Christine Lucente, S Luciani, D Luvarà, G Maffei, A Maggio, Luca Maggio, K Maiolo, L Malaigia, G Mangili, A Manna, E Maranella, Achille Marciano, P Marcozzi, Marcella Marletta, L Marseglia, Daniela Martinelli, Silvia Martinelli, S Massari, L Massenzi, F Matina, L Mattia, G Mescoli, I V Migliore, D Minghetti, I Mondello, S Montano, Giovanni Morandi, Nadia Mores, S Morreale, I Morselli, M Motta, M Napolitano, D Nardo, A Nicolardi, S Nider, G Nigro, Massimiliano Nuccio, L Orfeo, Cristiana Ottaviano, P Paganin, S Palamides, S Palatta, P Paolillo, M G Pappalardo, E Pasta, L Patti, G Paviotti, R Perniola, Germano Perotti, S Perrone, F Petrillo, M S Piazza, A Piccirillo, M Pierro, E Piga, G A Pingitore, S Pisu, C Pittini, F Pontiggia, G Pontrelli, A Primavera, A Proto, L Quartulli, F Raimondi, L Ramenghi, M Rapsomaniki, Alessandro Ricotti, C Rigotti, M Rinaldi, F M Risso, E Roma, Elia Romanini, Valentina Romano, E Rosati, V Rosella, I Rulli, V Salvo, C Sanfilippo, A Sannia, A Saporito, A Sauna, E Scapillati, F Schettini, A Scorrano, S Semeria Mantelli, V Sepporta, P Sindico, A Solinas, E Sorrentino, E Spaggiari, Alex Staffler, M Stella, D Termini, G Terrin, A Testa, G Tina, M Tirantello, B Tomasini, F Tormena, L Travan, D Trevisanuto, G Tuling, V Tulino, L Valenzano, S Vedovato, S Vendramin, Paolo Ernesto Villani, S Viola, V Viola, G Vitaliti, M Vitaliti, Petra Wanker, Y Yang, S Zanetta, E Zannin

Risultato della ricerca: Contributo in rivistaArticolo in rivistapeer review

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.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
RivistaTrials
Volume25
DOI
Stato di pubblicazionePubblicato - 2024

Keywords

  • HFOV
  • INRECSURE
  • Surfactant
  • Lung recruitment
  • Preterm infants
  • LISA

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