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1. Caution advised regarding lung recruitment before surfactant – Authors’ reply

Author

Vento, Giovanni, Ventura, M. L., Pastorino, Roberta, van Kaam, A. H., Carnielli, V., Cools, F., Dani, C., Mosca, F., Polglase, G., Tagliabue, P., Boni, L., Cota, Francesco, Tana, Milena, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Cost, S., D'Andrea, Vito, Lucente, Monica Christine, Nigro, G., Giordano, Lucia, Roma, V., Villani, P., Fusco, Francesca Paola, Fasolato, V., Colnaghi, M. R., Matassa, P. G., Vendettuoli, V., Poggi, C., Del Vecchi, A., Petrillo, F., Betta, P., Mattia, C., Garani, G., Solinas, A., Gitto, E., Salvo, V., Gargano, G., Balestri, E., Sandri, F., Mescoli, G., Martinelli, Silvia, Ilardi, L., Ciarmoli, E., Di Fabio, S., Maranella, E., Grassia, C., Ausanio, G., Rossi, V., Motta, A., Tina, L. G., Maiolo, K., Nobile, Stefano, Messner, H., Staffler, Alex, Ferrero, F., Stasi, I., Pieragostini, L., Mondello, I., Haass, C., Consigli, C., Vedovato, S., Grison, A., Maffei, G., Presta, G., Perniola, R., Vitaliti, M., Re, M. P., De Curtis, M., Cardilli, V., Lago, P., Tormena, F., Orfeo, L., Gizzi, C., Massenzi, L., Gazzolo, D., Strozzi, M. C. M., Bottino, R., Pontiggia, F., Berardi, A., Guidotti, I., Cacace, C., Meli, V., Quartulli, L., Scorrano, A., Casati, A., Grappone, L., Pillow, J. J., Vento G. (ORCID:0000-0002-8132-5127), Pastorino R. (ORCID:0000-0001-5013-0733), Cota F. (ORCID:0000-0002-9009-3997), Tana M., Tirone C., Aurilia C., Lio A., D'Andrea V. (ORCID:0000-0002-0980-799X), Lucente M., Giordano L., Fusco F. P., Martinelli S., Nobile S. (ORCID:0000-0002-5304-1485), Staffler A., Vento, Giovanni, Ventura, M. L., Pastorino, Roberta, van Kaam, A. H., Carnielli, V., Cools, F., Dani, C., Mosca, F., Polglase, G., Tagliabue, P., Boni, L., Cota, Francesco, Tana, Milena, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Cost, S., D'Andrea, Vito, Lucente, Monica Christine, Nigro, G., Giordano, Lucia, Roma, V., Villani, P., Fusco, Francesca Paola, Fasolato, V., Colnaghi, M. R., Matassa, P. G., Vendettuoli, V., Poggi, C., Del Vecchi, A., Petrillo, F., Betta, P., Mattia, C., Garani, G., Solinas, A., Gitto, E., Salvo, V., Gargano, G., Balestri, E., Sandri, F., Mescoli, G., Martinelli, Silvia, Ilardi, L., Ciarmoli, E., Di Fabio, S., Maranella, E., Grassia, C., Ausanio, G., Rossi, V., Motta, A., Tina, L. G., Maiolo, K., Nobile, Stefano, Messner, H., Staffler, Alex, Ferrero, F., Stasi, I., Pieragostini, L., Mondello, I., Haass, C., Consigli, C., Vedovato, S., Grison, A., Maffei, G., Presta, G., Perniola, R., Vitaliti, M., Re, M. P., De Curtis, M., Cardilli, V., Lago, P., Tormena, F., Orfeo, L., Gizzi, C., Massenzi, L., Gazzolo, D., Strozzi, M. C. M., Bottino, R., Pontiggia, F., Berardi, A., Guidotti, I., Cacace, C., Meli, V., Quartulli, L., Scorrano, A., Casati, A., Grappone, L., Pillow, J. J., Vento G. (ORCID:0000-0002-8132-5127), Pastorino R. (ORCID:0000-0001-5013-0733), Cota F. (ORCID:0000-0002-9009-3997), Tana M., Tirone C., Aurilia C., Lio A., D'Andrea V. (ORCID:0000-0002-0980-799X), Lucente M., Giordano L., Fusco F. P., Martinelli S., Nobile S. (ORCID:0000-0002-5304-1485), and Staffler A.

Abstract

N/A

Published
2021

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

Author

Vento, Giovanni, Ventura, M. L., Pastorino, Roberta, van Kaam, A. H., Carnielli, V., Cools, F., Dani, C., Mosca, F., Polglase, G., Tagliabue, P., Boni, L., Cota, Francesco, Tana, Milena, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Costa, Simonetta, D'Andrea, Vito, Lucente, M., Nigro, G., Giordano, Liliana, Roma, V., Villani, P. E., Fusco, Francesca Paola, Fasolato, V., Colnaghi, M. R., Matassa, P. G., Vendettuoli, V., Poggi, C., Del Vecchio, Arianna, Petrillo, F., Betta, P., Mattia, C., Garani, G., Solinas, A., Gitto, E., Salvo, V., Gargano, G., Balestri, E., Sandri, F., Mescoli, G., Martinelli, S., Ilardi, L., Ciarmoli, E., Di Fabio, S., Maranella, E., Grassia, C., Ausanio, G., Rossi, V., Motta, Alessandro, Tina, L. G., Maiolo, K., Nobile, Stefano, Messner, H., Staffler, Alex, Ferrero, Mattia Francesco, Stasi, I., Pieragostini, L., Mondello, I., Haass, C., Consigli, C., Vedovato, S., Grison, A., Maffei, G., Presta, G., Perniola, R., Vitaliti, M., Re, M. P., De Curtis, M., Cardilli, V., Lago, P., Tormena, F., Orfeo, L., Gizzi, C., Massenzi, L., Gazzolo, D., Strozzi, M. C. M., Bottino, R., Pontiggia, F., Berardi, A., Guidotti, I., Cacace, C., Meli, V., Quartulli, L., Scorrano, A., Casati, A., Grappone, L., Pillow, J. J., Vento G. (ORCID:0000-0002-8132-5127), Pastorino R. (ORCID:0000-0001-5013-0733), Cota F. (ORCID:0000-0002-9009-3997), Tana M., Tirone C., Aurilia C., Lio A., Costa S., D'Andrea V. (ORCID:0000-0002-0980-799X), Giordano L., Fusco F. P., Del Vecchio A., Motta A., Nobile S. (ORCID:0000-0002-5304-1485), Staffler A., Ferrero F., Vento, Giovanni, Ventura, M. L., Pastorino, Roberta, van Kaam, A. H., Carnielli, V., Cools, F., Dani, C., Mosca, F., Polglase, G., Tagliabue, P., Boni, L., Cota, Francesco, Tana, Milena, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Costa, Simonetta, D'Andrea, Vito, Lucente, M., Nigro, G., Giordano, Liliana, Roma, V., Villani, P. E., Fusco, Francesca Paola, Fasolato, V., Colnaghi, M. R., Matassa, P. G., Vendettuoli, V., Poggi, C., Del Vecchio, Arianna, Petrillo, F., Betta, P., Mattia, C., Garani, G., Solinas, A., Gitto, E., Salvo, V., Gargano, G., Balestri, E., Sandri, F., Mescoli, G., Martinelli, S., Ilardi, L., Ciarmoli, E., Di Fabio, S., Maranella, E., Grassia, C., Ausanio, G., Rossi, V., Motta, Alessandro, Tina, L. G., Maiolo, K., Nobile, Stefano, Messner, H., Staffler, Alex, Ferrero, Mattia Francesco, Stasi, I., Pieragostini, L., Mondello, I., Haass, C., Consigli, C., Vedovato, S., Grison, A., Maffei, G., Presta, G., Perniola, R., Vitaliti, M., Re, M. P., De Curtis, M., Cardilli, V., Lago, P., Tormena, F., Orfeo, L., Gizzi, C., Massenzi, L., Gazzolo, D., Strozzi, M. C. M., Bottino, R., Pontiggia, F., Berardi, A., Guidotti, I., Cacace, C., Meli, V., Quartulli, L., Scorrano, A., Casati, A., Grappone, L., Pillow, J. J., Vento G. (ORCID:0000-0002-8132-5127), Pastorino R. (ORCID:0000-0001-5013-0733), Cota F. (ORCID:0000-0002-9009-3997), Tana M., Tirone C., Aurilia C., Lio A., Costa S., D'Andrea V. (ORCID:0000-0002-0980-799X), Giordano L., Fusco F. P., Del Vecchio A., Motta A., Nobile S. (ORCID:0000-0002-5304-1485), Staffler A., and Ferrero F.

Abstract

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 (

Published
2020

3. Enteral Nutrition Tolerance and REspiratory Support (ENTARES) Study in preterm infants: Study protocol for a randomized controlled trial

Author

Cresi, F., Maggiora, E., Borgione, S. M., Spada, E., Coscia, Emanuele, Bertino, E., Meneghin, F., Corvaglia, L. T., Ventura, M. L., Lista, G., Mosca, F., Orsi, A., Mercadante, D., Martinelli, S., Ilardi, L., Proto, A., Gatto, S., Aceti, A., Sandri, F., Chakrokh, R., Laforgia, N., Di Mauro, A., Baldassarre, M. E., Del Vecchio, A., Petrillo, F., Spalierno, M. P., Raimondi, F., Capasso, L., Palma, M., Farina, D., Campagnoli, M. F., Boetti, T., Logrippo, F., Agosti, M., Morlacchi, L., Perniciaro, S., Dani, C., Elia, S., Vento, Giovanni, Maggio, Luca, Stronati, M., Civardi, E., Lidia, G., Angela, B., Coscia A., Vento G. (ORCID:0000-0002-8132-5127), Maggio L. (ORCID:0000-0001-6358-7775), Cresi, F., Maggiora, E., Borgione, S. M., Spada, E., Coscia, Emanuele, Bertino, E., Meneghin, F., Corvaglia, L. T., Ventura, M. L., Lista, G., Mosca, F., Orsi, A., Mercadante, D., Martinelli, S., Ilardi, L., Proto, A., Gatto, S., Aceti, A., Sandri, F., Chakrokh, R., Laforgia, N., Di Mauro, A., Baldassarre, M. E., Del Vecchio, A., Petrillo, F., Spalierno, M. P., Raimondi, F., Capasso, L., Palma, M., Farina, D., Campagnoli, M. F., Boetti, T., Logrippo, F., Agosti, M., Morlacchi, L., Perniciaro, S., Dani, C., Elia, S., Vento, Giovanni, Maggio, Luca, Stronati, M., Civardi, E., Lidia, G., Angela, B., Coscia A., Vento G. (ORCID:0000-0002-8132-5127), and Maggio L. (ORCID:0000-0001-6358-7775)

Abstract

Background: Respiratory distress syndrome (RDS) and feeding intolerance are common conditions in preterm infants and among the major causes of neonatal mortality and morbidity. For many years, preterm infants with RDS have been treated with mechanical ventilation, increasing risks of acute lung injury and bronchopulmonary dysplasia. In recent years non-invasive ventilation techniques have been developed. Showing similar efficacy and risk of bronchopulmonary dysplasia, nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) have become the most widespread techniques in neonatal intensive care units. However, their impact on nutrition, particularly on feeding tolerance and risk of complications, is still unknown in preterm infants. The aim of the study is to evaluate the impact of NCPAP vs HHHFNC on enteral feeding and to identify the most suitable technique for preterm infants with RDS. Methods: A multicenter randomized single-blind controlled trial was designed. All preterm infants with a gestational age of 25-29 weeks treated with NCPAP or HHHFNC for RDS and demonstrating stability for at least 48 h along with the compliance with inclusion criteria (age less than 7 days, need for non-invasive respiratory support, suitability to start enteral feeding) will be enrolled in the study and randomized to the NCPAP or HHHFNC arm. All patients will be monitored until discharge, and data will be analyzed according to an intention-to-treat model. The primary outcome is the time to reach full enteral feeding, while parameters of respiratory support, feeding tolerance, and overall health status will be evaluated as secondary outcomes. The sample size was calculated at 141 patients per arm. Discussion: The identification of the most suitable technique (NCPAP vs HHHFNC) for preterm infants with feeding intolerance could reduce gastrointestinal complications, improve growth, and reduce hospital length of stay, thus improving clinica

Published
2019

4. 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

Vento, Giovanni, Pastorino, Roberta, Boni, L, Cota, Francesco, Carnielli, V, Cools, F, Dani, C, Mosca, F, Pillow, J, Polglase, G, Tagliabue, Roberta Piera, van Kaam, Ah, Ventura, Ml, Tana, Milena, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Ricci, C, Gambacorta, Maria Antonietta, Consigli, C, D'Onofrio, D, Gizzi, C, Massenzi, L, Cardilli, V, Casati, A, Bottino, R, Pontiggia, Federico, Ciarmoli, E, Martinelli, S, Ilardi, L, Colnaghi, M, Matassa, Piero Giuseppe, Vendettuoli, Valentina, Villani, P, Fusco, Francesca Paola, Gazzolo, D, Ricotti, A, Ferrero, F, Stasi, I, Magaldi, R, Maffei, G, Presta, G, Perniola, R, Messina, F, Montesano, G, Poggi, C, Giordano, L, Roma, E, Grassia, C, Ausanio, G, Sandri, F, Mescoli, G, Giura, F, Garani, G, Solinas, A, Lucente, Michele, Nigro, G, Del Vecchio, Angela Maria, Petrillo, F, Orfeo, L, Grappone, L, Quartulli, L, Scorrano, Antonio, Messner, H, Staffler, Alex, Gargano, G, Balestri, E, Nobile, Stefano, Cacace, C, Meli, V, Dallaglio, S, Pasqua, B, Mattia, L, Gitto, E, Vitaliti, M, Re, Mp, Vedovato, S, Grison, A, Berardi, A, Torcetta, F, Guidotti, I, di Fabio, S, Maranella, E, Mondello, I, Visentin, S, Tormena, F., Vento, Giovanni (ORCID:0000-0002-8132-5127), Pastorino, Roberta (ORCID:0000-0001-5013-0733), Cota, Francesco (ORCID:0000-0002-9009-3997), Gambacorta, Maria Antonietta (ORCID:0000-0001-5455-8737), Nobile, S (ORCID:0000-0002-5304-1485), Vento, Giovanni, Pastorino, Roberta, Boni, L, Cota, Francesco, Carnielli, V, Cools, F, Dani, C, Mosca, F, Pillow, J, Polglase, G, Tagliabue, Roberta Piera, van Kaam, Ah, Ventura, Ml, Tana, Milena, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Ricci, C, Gambacorta, Maria Antonietta, Consigli, C, D'Onofrio, D, Gizzi, C, Massenzi, L, Cardilli, V, Casati, A, Bottino, R, Pontiggia, Federico, Ciarmoli, E, Martinelli, S, Ilardi, L, Colnaghi, M, Matassa, Piero Giuseppe, Vendettuoli, Valentina, Villani, P, Fusco, Francesca Paola, Gazzolo, D, Ricotti, A, Ferrero, F, Stasi, I, Magaldi, R, Maffei, G, Presta, G, Perniola, R, Messina, F, Montesano, G, Poggi, C, Giordano, L, Roma, E, Grassia, C, Ausanio, G, Sandri, F, Mescoli, G, Giura, F, Garani, G, Solinas, A, Lucente, Michele, Nigro, G, Del Vecchio, Angela Maria, Petrillo, F, Orfeo, L, Grappone, L, Quartulli, L, Scorrano, Antonio, Messner, H, Staffler, Alex, Gargano, G, Balestri, E, Nobile, Stefano, Cacace, C, Meli, V, Dallaglio, S, Pasqua, B, Mattia, L, Gitto, E, Vitaliti, M, Re, Mp, Vedovato, S, Grison, A, Berardi, A, Torcetta, F, Guidotti, I, di Fabio, S, Maranella, E, Mondello, I, Visentin, S, Tormena, F., Vento, Giovanni (ORCID:0000-0002-8132-5127), Pastorino, Roberta (ORCID:0000-0001-5013-0733), Cota, Francesco (ORCID:0000-0002-9009-3997), Gambacorta, Maria Antonietta (ORCID:0000-0001-5455-8737), and Nobile, S (ORCID:0000-0002-5304-1485)

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 h

Published
2016

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