1. 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
- Author
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Francesco Torcetta, Maria Lucente, Alessandro Gambacorta, Anton H. van Kaam, Agostina Solinas, Francesca Tormena, Alessandra Grison, J. Jane Pillow, Diego Gazzolo, Fabio Mosca, Giancarlo Gargano, Lorenzo Quartulli, Francesca Paola Fusco, P.G. Matassa, Flavia Petrillo, Carlo Dani, Maria Paola Re, Alessandra Casati, Alessandra Lio, Valentina Vendettuoli, Milena Tana, Carolina Grassia, Maria Luisa Ventura, E. Ciarmoli, Paolo E Villani, Alex Staffler, Gaetano Ausanio, Marcello Vitaliti, Betta Pasqua, Ilaria Stasi, Caterina Cacace, Stefano Nobile, Federica Pontiggia, Lucio Giordano, Chiara Consigli, Antonello Del Vecchio, Claudia Aurilia, Viviana Cardilli, Gabriella Nigro, Chiara Tirone, Eleonora Balestri, Giovanna Mescoli, Luigi Orfeo, Isotta Guidotti, Stefania Vedovato, Antonio Scorrano, Laura Ilardi, Graeme R. Polglase, Alberto Berardi, Giuseppe Presta, Eloisa Gitto, Francesco Giura, Giovanni Vento, Camilla Gizzi, Lidia Grappone, Hubert Messner, Fabrizio Sandri, Enza Roma, Roberta Pastorino, Valerio Meli, Chiara Poggi, Loretta Mattia, Virgilio P. Carnielli, Stefano Martinelli, Gianfranco Maffei, Federica Ferrero, Roberto Perniola, Eugenia Maranella, Sara Dallaglio, Alberto Ricotti, Cinzia Ricci, Francesco Messina, Paolo Tagliabue, Isabella Mondello, Danila D’Onofrio, Filip Cools, Sandra Di Fabio, Roberto Bottino, Luca Boni, Luca Massenzi, Giovanna Montesano, Francesco Cota, Rosario Magaldi, Stefano Visentin, Mariarosa Colnaghi, Giampaolo Garani, Faculty of Medicine and Pharmacy, Clinical sciences, Growth and Development, and Neonatology
- Subjects
Male ,Time Factors ,medicine.medical_treatment ,HFOV ,INSURE ,Lung recruitment ,Preterm infants ,Airway Extubation ,Biological Products ,Caffeine ,Central Nervous System Stimulants ,Citrates ,Continuous Positive Airway Pressure ,Female ,High-Frequency Ventilation ,Humans ,Infant, Newborn ,Intubation, Intratracheal ,Phospholipids ,Pulmonary Surfactants ,Respiratory Distress Syndrome, Newborn ,Treatment Outcome ,Infant, Premature ,Medicine (miscellaneous) ,Pharmacology (medical) ,Study Protocol ,0302 clinical medicine ,Functional residual capacity ,030212 general & internal medicine ,Continuous positive airway pressure ,Respiratory Distress Syndrome ,Respiratory distress ,High-frequency ventilation ,medicine.anatomical_structure ,Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA ,Anesthesia ,Breathing ,medicine.medical_specialty ,03 medical and health sciences ,030225 pediatrics ,medicine ,Intensive care medicine ,Premature ,Mechanical ventilation ,Lung ,business.industry ,Infant ,Newborn ,INSURE, Lung recruitment, Preterm infants, Medicine (miscellaneous), Pharmacology (medical) ,Intratracheal ,business ,Intubation - Abstract
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. 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. 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. ClinicalTrials.gov identifier: NCT02482766 . Registered on 1 June 2015.
- Published
- 2016
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