Lung recruitment before surfactant administration in extremely preterm neonates with respiratory distress syndrome (IN-REC-SUR-E): a randomised, unblinded, controlled trial. Issue 2 (February 2021)

• Record Type: Journal Article
• Authors: Vento, Giovanni; Ventura, Maria Luisa; Pastorino, Roberta; van Kaam, Anton H; Carnielli, Virgilio; Cools, Filip; Dani, Carlo; Mosca, Fabio; Polglase, Graeme; Tagliabue, Paolo; Boni, Luca; Cota, Francesco; Tana, Milena; Tirone, Chiara; Aurilia, Claudia; Lio, Alessandra; Costa, Simonetta; D'Andrea, Vito; Lucente, Mariella; Nigro, Gabriella; Giordano, Lucio; Roma, Vincenzina; Villani, Paolo E; Fusco, Francesca P; Fasolato, Valeria; Colnaghi, Maria Rosa; Matassa, Piero G; Vendettuoli, Valentina; Poggi, Chiara; Del Vecchio, Antonio; Petrillo, Flavia; Betta, Pasqua; Mattia, Carmine; Garani, Giampaolo; Solinas, Agostina; Gitto, Eloisa; Salvo, Vincenzo; Gargano, Giancarlo; Balestri, Eleonora; Sandri, Fabrizio; Mescoli, Giovanna; Martinelli, Stefano; Ilardi, Laura; Ciarmoli, Elena; Di Fabio, Sandra; Maranella, Eugenia; Grassia, Carolina; Ausanio, Gaetano; Rossi, Vincenzo; Motta, Angela; Tina, Lucia G; Maiolo, Kim; Nobile, Stefano; Messner, Hubert; Staffler, Alex; Ferrero, Federica; Stasi, Ilaria; Pieragostini, Luisa; Mondello, Isabella; Haass, Cristina; Consigli, Chiara; Vedovato, Stefania; Grison, Alessandra; Maffei, Gianfranco; Presta, Giuseppe; Perniola, Roberto; Vitaliti, Marcello; Re, Maria P; De Curtis, Mario; Cardilli, Viviana; Lago, Paola; Tormena, Francesca; Orfeo, Luigi; Gizzi, Camilla; Massenzi, Luca; Gazzolo, Diego; Strozzi, Maria Chiara M; Bottino, Roberto; Pontiggia, Federica; Berardi, Alberto; Guidotti, Isotta; Cacace, Caterina; Meli, Valerio; Quartulli, Lorenzo; Scorrano, Antonio; Casati, Alessandra; Grappone, Lidia; Pillow, J Jane;
• Is Part Of: Lancet. Volume 9:Issue 2(2021)
• Page Start: 159
• Page End: 166
• Publication Date: 2021-02
• Subjects: Respiratory organs -- Diseases -- Periodicals; 616.2005
• DOI: 10.1016/S2213-2600(20)30179-X
• Languages: English
• ISSNs: 2213-2600

Abstract

Summary: Background: The importance of lung recruitment before surfactant administration has been shown in animal studies. Well designed trials in preterm infants are absent. We aimed to examine whether the application of a recruitment manoeuvre just before surfactant administration, followed by rapid extubation (intubate-recruit-surfactant-extubate [IN-REC-SUR-E]), decreased the need for mechanical ventilation during the first 72 h of life compared with no recruitment manoeuvre (ie, intubate-surfactant-extubate [IN-SUR-E]). Methods: We did a randomised, unblinded, controlled trial in 35 tertiary neonatal intensive care units in Italy. Spontaneously breathing extremely preterm neonates (24 + 0 to 27 + 6 weeks' gestation) reaching failure criteria for continuous positive airway pressure within the first 24 h of life were randomly assigned (1:1) with a minimisation algorithm to IN-REC-SUR-E or IN-SUR-E using an interactive web-based electronic system, stratified by clinical site and gestational age. The primary outcome was the need for mechanical ventilation in the first 72 h of life. Analyses were done in intention-to-treat and per-protocol populations, with a log-binomial regression model correcting for stratification factors to estimate adjusted relative risk (RR). This study is registered with ClinicalTrials.gov, NCT02482766 . Findings: Of 556 infants assessed for eligibility, 218 infants were recruited from Nov 12, 2015, to Sept 23, 2018, and included in the intention-to-treat analysis. The requirement for mechanical ventilation during the first 72 h of life was reduced in the IN-REC-SUR-E group (43 [40%] of 107) compared with the IN-SUR-E group (60 [54%] of 111; adjusted RR 0·75, 95% CI 0·57–0·98; p=0·037), with a number needed to treat of 7·2 (95% CI 3·7–135·0). The addition of the recruitment manoeuvre did not adversely affect the safety outcomes of in-hospital mortality (19 [19%] of 101 in the IN-REC-SUR-E group vs 37 [33%] of 111 in the IN-SUR-E group), pneumothorax (four [4%] of 101 vs seven [6%] of 111), or grade 3 or worse intraventricular haemorrhage (12 [12%] of 101 vs 17 [15%] of 111). Interpretation: A lung recruitment manoeuvre just before surfactant administration improved the efficacy of surfactant treatment in extremely preterm neonates compared with the standard IN-SUR-E technique, without increasing the risk of adverse neonatal outcomes. The reduced need for mechanical ventilation during the first 72 h of life might facilitate implementation of a non-invasive respiratory support strategy. Funding: None.