Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: study protocol for a randomized controlled trial

Giovanni Vento, Roberta Pastorino, Luca Boni, Francesco Cota, Virgilio Carnielli, Filip Cools, Carlo Dani, Fabio Mosca, Jane Pillow, Graeme Polglase, Paolo Tagliabue, Anton H van Kaam, Maria Luisa Ventura, Milena Tana, Chiara Tirone, Claudia Aurilia, Alessandra Lio, Cinzia Ricci, Alessandro Gambacorta, Chiara Consigli, Danila D'Onofrio, Camilla Gizzi, Luca Massenzi, Viviana Cardilli, Alessandra Casati, Roberto Bottino, Federica Pontiggia, Elena Ciarmoli, Stefano Martinelli, Laura Ilardi, Mariarosa Colnaghi, Piero Giuseppe Matassa, Valentina Vendettuoli, Paolo Villani, Francesca Fusco, Diego Gazzolo, Alberto Ricotti, Federica Ferrero, Ilaria Stasi, Rosario Magaldi, Gianfranco Maffei, Giuseppe Presta, Roberto Perniola, Francesco Messina, Giovanna Montesano, Chiara Poggi, Lucio Giordano, Enza Roma, Carolina Grassia, Gaetano Ausanio, Fabrizio Sandri, Giovanna Mescoli, Francesco Giura, Giampaolo Garani, Agostina Solinas, Maria Lucente, Gabriella Nigro, Antonello Del Vecchio, Flavia Petrillo, Luigi Orfeo, Lidia Grappone, Lorenzo Quartulli, Antonio Scorrano, Hubert Messner, Alex Staffler, Giancarlo Gargano, Eleonora Balestri, Stefano Nobile, Caterina Cacace, Valerio Meli, Sara Dallaglio, Betta Pasqua, Loretta Mattia, Eloisa Gitto, Marcello Vitaliti, Maria Paola Re, Stefania Vedovato, Alessandra Grison, Alberto Berardi, Francesco Torcetta, Isotta Guidotti, Sandra di Fabio, Eugenia Maranella, Isabella Mondello, Stefano Visentin, Francesca Tormena, Giovanni Vento, Roberta Pastorino, Luca Boni, Francesco Cota, Virgilio Carnielli, Filip Cools, Carlo Dani, Fabio Mosca, Jane Pillow, Graeme Polglase, Paolo Tagliabue, Anton H van Kaam, Maria Luisa Ventura, Milena Tana, Chiara Tirone, Claudia Aurilia, Alessandra Lio, Cinzia Ricci, Alessandro Gambacorta, Chiara Consigli, Danila D'Onofrio, Camilla Gizzi, Luca Massenzi, Viviana Cardilli, Alessandra Casati, Roberto Bottino, Federica Pontiggia, Elena Ciarmoli, Stefano Martinelli, Laura Ilardi, Mariarosa Colnaghi, Piero Giuseppe Matassa, Valentina Vendettuoli, Paolo Villani, Francesca Fusco, Diego Gazzolo, Alberto Ricotti, Federica Ferrero, Ilaria Stasi, Rosario Magaldi, Gianfranco Maffei, Giuseppe Presta, Roberto Perniola, Francesco Messina, Giovanna Montesano, Chiara Poggi, Lucio Giordano, Enza Roma, Carolina Grassia, Gaetano Ausanio, Fabrizio Sandri, Giovanna Mescoli, Francesco Giura, Giampaolo Garani, Agostina Solinas, Maria Lucente, Gabriella Nigro, Antonello Del Vecchio, Flavia Petrillo, Luigi Orfeo, Lidia Grappone, Lorenzo Quartulli, Antonio Scorrano, Hubert Messner, Alex Staffler, Giancarlo Gargano, Eleonora Balestri, Stefano Nobile, Caterina Cacace, Valerio Meli, Sara Dallaglio, Betta Pasqua, Loretta Mattia, Eloisa Gitto, Marcello Vitaliti, Maria Paola Re, Stefania Vedovato, Alessandra Grison, Alberto Berardi, Francesco Torcetta, Isotta Guidotti, Sandra di Fabio, Eugenia Maranella, Isabella Mondello, Stefano Visentin, Francesca Tormena

Abstract

Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria.

Methods/design: In this study, 206 spontaneously breathing infants born at 24(+0)-27(+6) weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation.

Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge.

Trial registration: ClinicalTrials.gov identifier: NCT02482766 . Registered on 1 June 2015.

Keywords: HFOV; INSURE; Lung recruitment; Preterm infants.

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