Lung recruitment before surfactant administration in extremely preterm neonates with respiratory distress syndrome (IN-REC-SUR-E): a randomised, unblinded, controlled trial
| Autor: | Alessandra Lio, Roberto Perniola, Vincenzo Salvo, Lucio Giordano, Giuseppe Presta, Francesco Cota, Francesca Paola Fusco, Marcello Vitaliti, Eleonora Balestri, Sandra Di Fabio, Simonetta Costa, Lucia G Tina, Luigi Orfeo, Valeria Fasolato, Alex Staffler, Gaetano Ausanio, Mariarosa Colnaghi, Milena Tana, Luca Massenzi, Maria Luisa Ventura, Virgilio P. Carnielli, Camilla Gizzi, Maria Paola Re, Paolo Tagliabue, Alessandra Grison, Luisa Pieragostini, Chiara Consigli, Isotta Guidotti, Valerio Meli, Vito D'Andrea, Carmine Mattia, Fabio Mosca, Angela Motta, Antonio Del Vecchio, Eloisa Gitto, Anton H. van Kaam, Federica Ferrero, Graeme R. Polglase, Agostina Solinas, Francesca Tormena, Alessandra Casati, Roberto Bottino, Piero Giuseppe Matassa, Carolina Grassia, Stefano Nobile, Lidia Grappone, Mariella Lucente, Giampaolo Garani, Luca Boni, E. Ciarmoli, Claudia Aurilia, Viviana Cardilli, Flavia Petrillo, Carlo Dani, J. Jane Pillow, Federica Pontiggia, Gabriella Nigro, Diego Gazzolo, Filip Cools, Ilaria Stasi, Paola Lago, Lorenzo Quartulli, Giancarlo Gargano, Roberta Pastorino, Cristina Haass, Chiara Tirone, Hubert Messner, Alberto Berardi, Isabella Mondello, Fabrizio Sandri, Vincenzo Rossi, Eugenia Maranella, Vincenzina Roma, Maria Chiara Strozzi, Paolo E Villani, Chiara Poggi, Giovanni Vento, Giovanna Mescoli, Stefania Vedovato, Antonio Scorrano, Laura Ilardi, Valentina Vendettuoli, Caterina Cacace, Stefano Martinelli, Gianfranco Maffei, Mario De Curtis, Pasqua Betta, Kim Maiolo |
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| Přispěvatelé: | Clinical sciences, Growth and Development, Neonatology, ARD - Amsterdam Reproduction and Development |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pulmonary and Respiratory Medicine
Male Critical Care medicine.medical_treatment surfactant law.invention lung Randomized controlled trial law Intensive care Intensive Care Units Neonatal medicine Intubation Intratracheal Humans extremely preterm neonates Continuous positive airway pressure preterm infants Pediatrics Perinatology and Child Health IN-REC-SUR-E Mechanical ventilation Respiratory Distress Syndrome Newborn Respiratory distress business.industry Infant Newborn Gestational age Pulmonary Surfactants Respiration Artificial respiratory distress syndrome Treatment Outcome Italy Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA Relative risk Anesthesia Infant Extremely Premature Number needed to treat Airway Extubation Female business |
| Zdroj: | lancet. Respiratory medicine, 9(2), 159-166. Elsevier Limited |
| ISSN: | 2213-2600 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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