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1. Comparison of “IN-REC-SUR-E” and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial)

Author

Vento, Giovanni, Paladini, Angela, Aurilia, C., Ozdemir, S. Alkan, Carnielli, V. P., Cools, F., Costa, S., Cota, F., Dani, C., Davis, P. G., Fattore, S., Fè, C., Finer, N., Fusco, F. P., Gizzi, C., Herting, E., Jian, M., Lio, A., Lista, G., Mosca, F., Nobile, S., Perri, A., Picone, S., Pillow, J. J., Polglase, G., Pasciuto, T., Pastorino, R., Tana, M., Tingay, D., Tirone, C., van Kaam, A. H., Ventura, M. L., Aceti, A., Agosti, M., Alighieri, G., Ancora, G., Angileri, V., Ausanio, G., Aversa, S., Balestri, E., Baraldi, E., Barbini, M. C., Barone, C., Beghini, R., Bellan, C., Berardi, A., Bernardo, I., Betta, P., Binotti, M., Bizzarri, B., Borgarello, G., Borgione, S., Borrelli, A., Bottino, R., Bracaglia, G., Bresesti, I., Burattini, I., Cacace, C., Calzolari, F., Campagnoli, M. F., Capasso, L., Capozza, M., Capretti, M. G., Caravetta, J., Carbonara, C., Cardilli, V., Carta, M., Castoldi, F., Castronovo, A., Cavalleri, E., Cavigioli, F., Cecchi, S., Chierici, V., Cimino, C., Cocca, F., Cocca, C., Cogo, P., Coma, M., Comito, V., Condò, V., Consigli, C., Conti, R., Corradi, M., Corsello, G., Corvaglia, L. T., Costa, A., Coscia, A., Cresi, F., Crispino, F., D’Amico, P., De Cosmo, L., De Maio, C., Del Campo, G., Di Credico, S., Di Fabio, S., Di Nicola, P., Di Paolo, A., Di Valerio, S., Distilo, A., Duca, V., Falcone, A., Falsaperla, R., Fasolato, V. A., Fatuzzo, V., Favini, F., Ferrarello, M. P., Ferrari, S., Nastro, F. Fiori, Forcellini, C. A., Fracchiolla, A., Gabriele, A., Galdo, F., Gallini, F., Gangemi, A., Gargano, G., Gazzolo, D., Gentile, M. P., Ghirardello, S., Giardina, F., Giordano, L., Gitto, E., Giuffrè, M., Grappone, L., Grasso, F., Greco, I., Grison, A., Guglielmino, R., Guidotti, I., Guzzo, I., La Forgia, N., La Placa, S., La Torre, G., Lago, P., Lanciotti, L., Lavizzari, A., Leo, F., Leonardi, V., Lestingi, D., Li, J., Liberatore, P., Lodin, D., Lubrano, R., Lucente, M., Luciani, S., Luvarà, D., Maffei, G., Maggio, A., Maggio, L., Maiolo, K., Malaigia, L., Mangili, G., Manna, A., Maranella, E., Marciano, A., Marcozzi, P., Marletta, M., Marseglia, L., Martinelli, D., Martinelli, S., Massari, S., Massenzi, L., Matina, F., Mattia, L., Mescoli, G., Migliore, I. V., Minghetti, D., Mondello, I., Montano, S., Morandi, G., Mores, N., Morreale, S., Morselli, I., Motta, M., Napolitano, M., Nardo, D., Nicolardi, A., Nider, S., Nigro, G., Nuccio, M., Orfeo, L., Ottaviano, C., Paganin, P., Palamides, S., Palatta, S., Paolillo, P., Pappalardo, M. G., Pasta, E., Patti, L., Paviotti, G., Perniola, R., Perotti, G., Perrone, S., Petrillo, F., Piazza, M. S., Piccirillo, A., Pierro, M., Piga, E., Pingitore, G. A., Pisu, S., Pittini, C., Pontiggia, F., Pontrelli, G., Primavera, A., Proto, A., Quartulli, L., Raimondi, F., Ramenghi, L., Rapsomaniki, M., Ricotti, A., Rigotti, C., Rinaldi, M., Risso, F. M., Roma, E., Romanini, E., Romano, V., Rosati, E., Rosella, V., Rulli, I., Salvo, V., Sanfilippo, C., Sannia, A., Saporito, A., Sauna, A., Scapillati, E., Schettini, F., Scorrano, A., Mantelli, S. Semeria, Sepporta, V., Sindico, P., Solinas, A., Sorrentino, E., Spaggiari, E., Staffler, A., Stella, M., Termini, D., Terrin, G., Testa, A., Tina, G., Tirantello, M., Tomasini, B., Tormena, F., Travan, L., Trevisanuto, D., Tuling, G., Tulino, V., Valenzano, L., Vedovato, S., Vendramin, S., Villani, P. E., Viola, S., Viola, V., Vitaliti, G., Vitaliti, M., Wanker, P., Yang, Y., Zanetta, S., and Zannin, E.

Published
2024
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2. 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

3. 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

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

Author

Vento, Giovanni, primary, Ventura, M L, additional, Pastorino, R, additional, van Kaam, A H, additional, Carnielli, V, additional, Cools, F, additional, Dani, C, additional, Mosca, F, additional, Polglase, G, additional, Tagliabue, P, additional, Boni, L, additional, Cota, F, additional, Tana, M, additional, Tirone, C, additional, Aurilia, C, additional, Lio, A, additional, Cost, S, additional, D'Andrea, V, additional, Lucente, M, additional, Nigro, G, additional, Giordano, L, additional, Roma, V, additional, Villani, P, additional, Fusco, F P, additional, Fasolato, V, additional, Colnaghi, M R, additional, Matassa, P G, additional, Vendettuoli, V, additional, Poggi, C, additional, Del Vecchi, A, additional, Petrillo, F, additional, Betta, P, additional, Mattia, C, additional, Garani, G, additional, Solinas, A, additional, Gitto, E, additional, Salvo, V, additional, Gargano, G, additional, Balestri, E, additional, Sandri, F, additional, Mescoli, G, additional, Martinelli, S, additional, Ilardi, L, additional, Ciarmoli, E, additional, Di Fabio, S, additional, Maranella, E, additional, Grassia, C, additional, Ausanio, G, additional, Rossi, V, additional, Motta, A, additional, Tina, L G, additional, Maiolo, K, additional, Nobile, S, additional, Messner, H, additional, Staffler, A, additional, Ferrero, F, additional, Stasi, I, additional, Pieragostini, L, additional, Mondello, I, additional, Haass, C, additional, Consigli, C, additional, Vedovato, S, additional, Grison, A, additional, Maffei, G, additional, Presta, G, additional, Perniola, R, additional, Vitaliti, M, additional, Re, M P, additional, De Curtis, M, additional, Cardilli, V, additional, Lago, P, additional, Tormena, F, additional, Orfeo, L, additional, Gizzi, C, additional, Massenzi, L, additional, Gazzolo, D, additional, Strozzi, M C M, additional, Bottino, R, additional, Pontiggia, F, additional, Berardi, A, additional, Guidotti, I, additional, Cacace, C, additional, Meli, V, additional, Quartulli, L, additional, Scorrano, A, additional, Casati, A, additional, Grappone, L, additional, and Pillow, J J, additional

Published
2021
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5. Caution advised regarding lung recruitment before surfactant – Authors’ reply

Author

Ventura, M L, Pastorino, R, van Kaam, A H, Carnielli, V, Cools, F, Dani, C, Mosca, F, Polglase, G, Tagliabue, P, Boni, L, Cota, F, Tana, M, Tirone, C, Aurilia, C, Lio, A, Cost, S, D'Andrea, V, Lucente, M, Nigro, G, Giordano, L, Roma, V, Villani, P, Fusco, F P, 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, S, Ilardi, L, Ciarmoli, E, Di Fabio, S, Maranella, E, Grassia, C, Ausanio, G, Rossi, V, Motta, A, Tina, L G, Maiolo, K, Nobile, S, Messner, H, Staffler, A, 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, and Vento, Giovanni

Published
2021
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6. 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

7. Desarrollo tecnológico con aplicación en terapias fotodinámicas para el tratamiento de lesiones de la piel

Author

Bustos Fierro, Carolina, Gavelli, María Emilia, Juarez, Andrea, Pizarro, R., Jurgens, C., Manzo, R.H., Pittau, R., Romero, J.L., Boetto, N., Consigli, C., and Olivera, M.E.

Subjects
ácido α-aminolevulínico, queratosis actínica, terapia fotodinámica
Abstract

La terapia fotodinámica es un tratamiento de primera línea para ciertas lesiones de la piel como la queratosis actínica (QA). Con tales fines se emplean emisores de luz con alto costo de adquisición y mantenimiento. El Departamento de Bioingeniería, del Centro de Microscopía Electrónica de la Facultad de Ciencias Médicas, Universidad Nacional de Córdoba (UNC), desarrolló una nueva versión de dispositivo emisor, de bajo costo de fabricación, que emite luz pulsada intensa y es capaz de irradiar luz roja (630 nm) y azul (405 nm). Este dispositivo es potencialmente útil en el tratamiento de QA y carcinoma basocelular. Por otra parte el Departamento de Farmacia de la Facultad de Ciencias Químicas, UNC, ha formulado el compuesto basado en el ácido α- aminolevulínico (ALA) que es el precursor del agente fotosensibilizador protoporfirina IX, habilitado por la ANMAT en presentaciones similares, y la Farmacia Central del Hospital Nacional de Clínicas (HNC) de la UNC, efectuó la preparación del medicamento como formulación magistral y extemporánea al 20%. Todas estas dependencias internas de la UNC articularon en la ejecución de un proyecto de Innovación Tecnológica, financiado por la SECYT-UNC, a los fines de completar las etapas de desarrollo y los estudios necesarios, para poder utilizar el equipamiento y el medicamento para terapias en el mencionado hospital. El presente trabajo aborda de manera particular, los resultados preliminares obtenidos en el estudio clínico, realizado en el área de Dermatología del HNC. Cabe destacar que como parte del proyecto, se pretende la construcción en serie del dispositivo emisor a través de la Institución Contraparte participante del proyecto, que es una reconocida empresa local fabricante de equipamiento médico. publishedVersion

Published
2014

10. Survey of neonatal respiratory care and surfactant administration in very preterm infants in the Italian neonatal network

Author

Bellù R, Gagliardi L, Tagliabue P, Corchia C, Vendettuoli V, Mosca F, Zanini R, Condò M, Turoli D, Weissmann G, Vanzati M, De Nisi G, Villa E, Moro G, Guerrini P, Contiero R, Ellero S, Furlan R, Abbiati L, Borroni C, Prandi G, Fabris C, Vielmi F, Agosti M, Tandoi F, Guidali, De Curtis M, Tozzi C, Lucchini R, Battaglioli M, Lista GL, Introvini P, Ferrari F, Gallo C, Cervello P, Bellante E, Bottura C, Pasquali F, Boccacci S, Latini G, Giannuzzi R, Martinelli S, Brunelli A, Motta G, Di Nunzio ML, Vendemiati A, Zorzi C, Carli G, Alfiero, Romeo N, Mammoliti P, Mastretta E, Barberis L, Farina D, Gancia G, Dalmazzo C, Napolitano M, Messina F, Rinaldi G, Magaldi R, Rinaldi M, Litta R, Lago P, Zanardo V, Chiandetti L, Visentin S, Presta G, Cella D, Poggiani C, Ferrari D, Parati S, Lombardo F, Grigorio R, Barera G, Franco M, Poloniato A, Colombo A, Burgio G, Sala E, Barberi I, Tiralongo V, Arco A, Careggi F, Dani C, Pratesi S, Mignatti V, Ancora G, Faldella G, Grandi S, Stronati M, Perotti G, Chirico G, Migliori C, De Marini S, Forleo V, Mansi G, Bona G, Stucchi I, Savastio, Ferrero F, Parola A, Padovani EM, Viviani E, Pecoraro L, Tiberina FI, Agostino R, Gizzi C, Massenzi L, Messner H, Staffier A, Salvia G, Esposito L, Forziati V, Latorre G, Sandri F, Alati S, Demaria F, Lombardi O, Costabile CD, Scarpelli G, Cavalli C, Volante E, Proietti D, Ganguzza O, Spinella B, Pietro RS, Haass C, Scapillati E, Consigli C, Gatta A, Quitadamo P, Boldrini A, Vuerich M, Sigali E, Ghirri P, Fiorini P, Petrucci L, Moroni M, Braghetti P, Casucci P, Minelli L, Mezzetti D, Orfeo L, De Luca MG, Laforgia N, Grassi A, Gesu RB, Dotta A, Savignoni F, Bagnoli F, De Felice C, Badii S, Biasini A, Belluzzi A, Stella M, Romagnoli C, Zecca E, Barone G, Colleselli P, Vecchiato L, Nicolussi D, Monaldi N, Giliberti P, Chello G, Rojo S, Giovanettoni C, Colnaghi CA, Verucci E, Placidi G, Belloni C, Carrera G, Zambetti C, Biban P, Serra A, Carnielli V, Pedini A, Vetrano G, Furcolo G, Pasquariello B, Falco L, Ausanio G, Bernardo I, Marchesano G, Nosari N, Sarnelli P, Maccabruni M, Merazzi D, Gazzolo D, Sabatini FT, Colivicchi M, Del Vecchio A, Tarantino M, Gargano G, Pedori S, Bellettato M, Pesavento R, Cesaro A, Nicolò A, Mondello I, Pugliese A, Iervolino C, Corsello G, Giuffré M, Betta M, Romeo MG, Saporito A, D'Incecco C, Perrone B, Rodonò MG, Serra G, Franceschi A, Risso FM, Carpentieri M, Cigliano MP, Casilino R, Paolillo P, Picone S, Marra A, Rossetti D, Testa T, Del Cuore F., PALUDETTO, ROBERTO, CAPASSO, LETIZIA, RAIMONDI, FRANCESCO, Bellù, R, Gagliardi, L, Tagliabue, P, Corchia, C, Vendettuoli, V, Mosca, F, Zanini, R, Corsello, G, Giuffrè, M, Italian Neonatal Network., Condò, M, Turoli, D, Weissmann, G, Vanzati, M, De Nisi, G, Villa, E, Moro, G, Guerrini, P, Contiero, R, Ellero, S, Furlan, R, Abbiati, L, Borroni, C, Prandi, G, Fabris, C, Vielmi, F, Agosti, M, Tandoi, F, Guidali, De Curtis, M, Tozzi, C, Lucchini, R, Battaglioli, M, Lista, Gl, Introvini, P, Ferrari, F, Gallo, C, Cervello, P, Bellante, E, Bottura, C, Pasquali, F, Boccacci, S, Latini, G, Giannuzzi, R, Martinelli, S, Brunelli, A, Motta, G, Di Nunzio, Ml, Vendemiati, A, Zorzi, C, Carli, G, Alfiero, Romeo, N, Mammoliti, P, Mastretta, E, Barberis, L, Farina, D, Gancia, G, Dalmazzo, C, Napolitano, M, Messina, F, Rinaldi, G, Magaldi, R, Rinaldi, M, Litta, R, Lago, P, Zanardo, V, Chiandetti, L, Visentin, S, Presta, G, Cella, D, Poggiani, C, Ferrari, D, Parati, S, Lombardo, F, Grigorio, R, Barera, G, Franco, M, Poloniato, A, Colombo, A, Burgio, G, Sala, E, Barberi, I, Tiralongo, V, Arco, A, Careggi, F, Dani, C, Pratesi, S, Mignatti, V, Ancora, G, Faldella, G, Grandi, S, Stronati, M, Perotti, G, Chirico, G, Migliori, C, De Marini, S, Forleo, V, Paludetto, Roberto, Capasso, Letizia, Mansi, G, Raimondi, Francesco, Bona, G, Stucchi, I, Savastio, Ferrero, F, Parola, A, Padovani, Em, Viviani, E, Pecoraro, L, Tiberina, Fi, Agostino, R, Gizzi, C, Massenzi, L, Messner, H, Staffier, A, Salvia, G, Esposito, L, Forziati, V, Latorre, G, Sandri, F, Alati, S, Demaria, F, Lombardi, O, Costabile, Cd, Scarpelli, G, Cavalli, C, Volante, E, Proietti, D, Ganguzza, O, Spinella, B, Pietro, R, Haass, C, Scapillati, E, Consigli, C, Gatta, A, Quitadamo, P, Boldrini, A, Vuerich, M, Sigali, E, Ghirri, P, Fiorini, P, Petrucci, L, Moroni, M, Braghetti, P, Casucci, P, Minelli, L, Mezzetti, D, Orfeo, L, De Luca, Mg, Laforgia, N, Grassi, A, Gesu, Rb, Dotta, A, Savignoni, F, Bagnoli, F, De Felice, C, Badii, S, Biasini, A, Belluzzi, A, Stella, M, Romagnoli, C, Zecca, E, Barone, G, Colleselli, P, Vecchiato, L, Nicolussi, D, Monaldi, N, Giliberti, P, Chello, G, Rojo, S, Giovanettoni, C, Colnaghi, Ca, Verucci, E, Placidi, G, Belloni, C, Carrera, G, Zambetti, C, Biban, P, Serra, A, Carnielli, V, Pedini, A, Vetrano, G, Furcolo, G, Pasquariello, B, Falco, L, Ausanio, G, Bernardo, I, Marchesano, G, Nosari, N, Sarnelli, P, Maccabruni, M, Merazzi, D, Gazzolo, D, Sabatini, Ft, Colivicchi, M, Del Vecchio, A, Tarantino, M, Gargano, G, Pedori, S, Bellettato, M, Pesavento, R, Cesaro, A, Nicolò, A, Mondello, I, Pugliese, A, Iervolino, C, Giuffré, M, Betta, M, Romeo, Mg, Saporito, A, D'Incecco, C, Perrone, B, Rodonò, Mg, Serra, G, Franceschi, A, Risso, Fm, Carpentieri, M, Cigliano, Mp, Casilino, R, Paolillo, P, Picone, S, Marra, A, Rossetti, D, Testa, T, and Del Cuore, F.

Subjects
Preterm infants, Ventilation, Ventilatory support, Medicine (all), Drug Utilization, Humans, Infant Mortality, Infant, Newborn, Infant, Very Low Birth Weight, Intubation, Intratracheal, Italy, Oxygen Inhalation Therapy, Pulmonary Surfactants, Respiration, Artificial, Infant, Premature, Settore MED/38 - Pediatria Generale E Specialistica, Premature, Very Low Birth Weight, Respiration, Infant, Newborn, national survay, Intratracheal, Very preterm infant, national survay, neonatal respiratory care, Very preterm infant, Artificial, Preterm infant, neonatal respiratory care, Intubation
Abstract

INTRODUCTION: Variation of respiratory care is described between centers around the world. The Italian Neonatal Network (INN), as a national group of the Vermont-Oxford Network (VON) allows to perform a wide analysis of respiratory care in very low birth weight infants. METHODS: We analyzed the dataset of infants enrolled in the INN in 2009 and 2010 and, for surfactant administration only, from 2006 to 2010 from 83 participating centers. All definitions are those of the (VON). A questionnaire analysis was also performed with a questionnaire on centers practices. RESULTS: We report data for 8297 infants. Data on ventilator practices and outcomes are outlined. Variation for both practices and outcome is found. Trend in surfactant administration is also analyzed. CONCLUSIONS. The great variation across hospitals in all the surveyed techniques points to the possibility of implementing potentially better practices with the aim of reducing unwanted variation. These data also show the power of large neonatal networks in identifying areas for potential improvement.

11. The architecture of the software implemented by CREI for EIN

Author

Le Moli, G, Affò, G, Andreoni, G, Baldini, L, Belloni, A, Boccia, D, Bozzetti, M, Cellamare, E, Consigli, C, Crippa, E, Faro, A, Floro, M, Gambaro, A, Palazzo, Sergio, Radassao, E, Repossi, E, Restelli, R, Riccardi, V, Rossi, P, Scollo, Giuseppe, and Zupa, P.

Published
1979

12. Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial.

Author

Gallini F, De Rose DU, Iuliano R, Romeo DM, Tana M, Paladini A, Fusco FP, Nobile S, Cota F, Tirone C, Aurilia C, Lio A, Esposito A, Costa S, D'Andrea V, Ventura ML, Carnielli V, Dani C, Mosca F, Fumagalli M, Scarpelli G, Giordano L, Fasolato V, Petrillo F, Betta P, Solinas A, Gitto E, Gargano G, Mescoli G, Martinelli S, Di Fabio S, Bernardo I, Tina LG, Staffler A, Stasi I, Mondello I, Scapillati E, Vedovato S, Maffei G, Bove A, Vitaliti M, Terrin G, Lago P, Gizzi C, Strozzi C, Villani PE, Berardi A, Cacace C, Bracaglia G, Pascucci E, Cools F, Pillow JJ, Polglase G, Pastorino R, van Kaam AH, Mercuri E, Orfeo L, Vento G, Malguzzi S, Rigotti C, Cecchi A, Nigro G, Costabile CD, Roma E, Sindico P, Venafra R, Mattia C, Conversano M, Ballardini E, Manganaro A, Balestri E, Gallo C, Catenazzi P, Astori MG, Maranella E, Grassia C, Maiolo K, Castellano D, Massenzi L, Chiodin E, Gallina MR, Consigli C, Sorrentino E, Bonato S, Mancini M, Perniola R, Giannuzzo S, Tranchina E, Cardilli V, Dito L, Regoli D, Tormena F, Battajon N, Arena R, Allais B, Guidotti I, Roversi F, Meli V, Tulino V, and Casati A

Subjects
Humans, Male, Female, Infant, Newborn, Follow-Up Studies, High-Frequency Ventilation methods, Child, Preschool, Intensive Care Units, Neonatal statistics & numerical data, Treatment Outcome, Italy, Infant, Pulmonary Surfactants administration & dosage, Pulmonary Surfactants therapeutic use, Infant, Extremely Premature, Respiratory Distress Syndrome, Newborn therapy, Respiratory Distress Syndrome, Newborn drug therapy
Abstract

Importance: A multicenter randomized clinical trial (RCT) showed a lung recruitment maneuver using high-frequency oscillatory ventilation just before surfactant administration (ie, intubate-recruit-surfactant-extubate [IN-REC-SUR-E]) improved the efficacy of treatment compared with the standard intubate-surfactant-extubate (IN-SUR-E) technique without increasing the risk of adverse neonatal outcomes., Objective: To examine follow-up outcomes at corrected postnatal age (cPNA) 2 years of preterm infants previously enrolled in an RCT and treated with IN-REC-SUR-E or IN-SUR-E in 35 tertiary neonatal intensive care units., Design, Setting, and Participants: This was a follow-up study of infants recruited into the primary RCT from 2015 to 2018 at 35 tertiary neonatal intensive care units (NICUs) in Italy. Follow-up examinations included neurodevelopmental, growth, and respiratory outcomes of these children at cPNA 2 years. Participants included spontaneously breathing extremely preterm neonates (24 0/7 to 27 6/7 weeks' gestation) reaching failure criteria for continuous positive airway pressure within the first 24 hours of life. Data were analyzed from April 2023 to January 2024., Intervention: Infants were randomly assigned (1:1) to IN-REC-SUR-E or IN-SUR-E and then followed up., Main Outcomes and Measures: The primary outcome was the occurrence of death after discharge or major disability at cPNA 2 years. Secondary outcomes were neurodevelopmental outcomes (major disability, cerebral palsy, cognitive impairment, visual deficit, or auditory deficit), anthropometric measurements (weight, length, and head circumference), and recurrent respiratory infections and hospitalizations because of respiratory causes at 2y cPNA., Results: A total of 137 extremely preterm infants (median [IQR] gestational age, 26.5 [25.3-27.5] weeks and 75 [54.7%] female), initially enrolled in the original RCT, were followed up at cPNA 2 years, including 64 infants in the IN-SUR-E group and 73 infants in the IN-REC-SUR-E group. There were no significant differences in the occurrence of death after discharge or major disability at cPNA 2 years (IN-SUR-E: 13 children [20.3%] vs IN-REC-SUR-E: 10 children [13.7%]; P = .36). There were no significant differences in incidence of disability, cerebral palsy, or cognitive impairment in the IN-REC-SUR-E group compared with the IN-SUR-E group. There were no significant differences in anthropometric measurements (weight, length, and head circumference) between groups. There were no significant differences in the incidence of recurrent respiratory infections or in hospitalizations because of respiratory causes between groups., Conclusions and Relevance: In this RCT of lung recruitment before surfactant vs standard care there were no significant differences between the 2 groups in death, neurodevelopmental outcomes, anthropometric measurements, or recurrent respiratory infections at the 2-year follow-up. These findings can aid clinicians in decision-making for the best strategy to administer surfactant, considering long-term outcomes.

Published
2024
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13. A bicentric cohort study comparing umbilical cord and neonatal blood samples for chemistry tests at birth.

Author

Calafatti M, Gizzi C, Simonelli I, Papa F, Consigli C, Sorrentino E, Haas C, and Massenzi L

Subjects
Infant, Infant, Newborn, Humans, Cohort Studies, Prospective Studies, Fetal Blood, Umbilical Cord, Blood Transfusion
Abstract

Objectives: To compare umbilical cord and neonatal blood for chemistry tests upon admission to the neonatal intensive care unit (NICU)., Methods: We designed a prospective, bicentric cohort study enrolling newborns (n = 71) with a planned admission to the NICU. Paired samples of umbilical cord and infant's blood were collected, analyzed, and compared. An intraclass correlation coefficient (ICC) was calculated for a repeatability analysis, and a Bland-Altman analysis was performed to assess the agreement between the 2 methods of sampling. The multivariable coefficient of determination (R2) was reported to quantify the degree of correlation between the methods of measurement., Results: The degree of agreement between the 2 sampling methods for chemistry tests was fair to good for high-sensitivity C-reactive protein (ICC = 0.79 [95% CI, 0.67-0.87]), phosphorus (ICC = 0.83 [95% CI, 0.73-0.90]), and albumin (ICC = 0.76 [95% CI, 0.60-0.86]), while it was good to excellent for γ-glutamyl transpeptidase (ICC = 0.95 [95% CI, 0.88-0.98]) and procalcitonin (ICC = 0.90 [95% CI, 0.76-0.96])., Conclusions: Umbilical cord blood is a reliable replacement source for multiple chemistry tests at birth. This sampling method has the potential to minimize the risk of transfusion-requiring anemia in newborns and its associated complications. Further studies are warranted to assess the efficacy of this strategy in improving neonatal outcomes., (© The Author(s) 2023. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2023
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14. Lung recruitment before surfactant administration in extremely preterm neonates with respiratory distress syndrome (IN-REC-SUR-E): a randomised, unblinded, controlled trial.

Author

Vento G, Ventura ML, Pastorino R, van Kaam AH, Carnielli V, Cools F, Dani C, Mosca F, Polglase G, Tagliabue P, Boni L, Cota F, Tana M, Tirone C, Aurilia C, Lio A, Costa S, D'Andrea V, Lucente M, Nigro G, Giordano L, Roma V, Villani PE, Fusco FP, Fasolato V, Colnaghi MR, Matassa PG, Vendettuoli V, Poggi C, Del Vecchio A, 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 A, Tina LG, Maiolo K, Nobile S, Messner H, Staffler A, 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 MP, De Curtis M, Cardilli V, Lago P, Tormena F, Orfeo L, Gizzi C, Massenzi L, Gazzolo D, Strozzi MCM, Bottino R, Pontiggia F, Berardi A, Guidotti I, Cacace C, Meli V, Quartulli L, Scorrano A, Casati A, Grappone L, and Pillow JJ

Subjects
Female, Humans, Infant, Extremely Premature, Infant, Newborn, Intensive Care Units, Neonatal, Italy, Lung physiopathology, Male, Respiration, Artificial statistics & numerical data, Treatment Outcome, Airway Extubation methods, Critical Care methods, Intubation, Intratracheal methods, Pulmonary Surfactants therapeutic use, Respiratory Distress Syndrome, Newborn therapy
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 (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., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Published
2021
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15. Nasal high-frequency oscillatory ventilation and CO 2 removal: A randomized controlled crossover trial.

Author

Bottino R, Pontiggia F, Ricci C, Gambacorta A, Paladini A, Chijenas V, Liubsys A, Navikiene J, Pliauckiene A, Mercadante D, Colnaghi M, Tana M, Tirone C, Lio A, Aurilia C, Pastorino R, Purcaro V, Maffei G, Liberatore P, Consigli C, Haass C, Lista G, Agosti M, Mosca F, and Vento G

Subjects
Birth Weight, Cross-Over Studies, Female, Gestational Age, Humans, Infant, Infant, Newborn, Infant, Premature, Intensive Care Units, Neonatal, Italy, Lithuania, Male, Noninvasive Ventilation methods, Nose physiology, Prospective Studies, Ventilators, Mechanical, Carbon Dioxide chemistry, Continuous Positive Airway Pressure methods, High-Frequency Ventilation, Intermittent Positive-Pressure Ventilation methods, Ventilator Weaning methods
Abstract

Objective: To compare short-term application of nasal high-frequency oscillatory ventilation (nHFOV) with nasal continuous positive airway pressure (nCPAP)., Working Hypothesis: nHFOV improves CO 2 removal with respect to nCPAP in preterm infants needing noninvasive respiratory support and persistent oxygen supply after the first 72 h of life., Study Design: Multicenter non-blinded prospective randomized crossover study., Patient Selection: Thirty premature infants from eight tertiary neonatal intensive care units, of mean ± SD 26.4 ± 1.8 weeks of gestational age and 921 ± 177 g of birth weight., Methodology: Infants were randomly allocated in a 1:1 ratio to receive a starting treatment mode of either nCPAP or nHFOV delivered by the ventilator CNO (Medin, Germany), using short binasal prongs of appropriate size. A crossover design with four 1-h treatment periods was used, such that each infant received both treatments twice. The primary outcome was the mean transcutaneous partial pressure of CO 2 (TcCO 2 ) value during the 2-h cumulative period of nHFOV compared with the 2-h cumulative period of nCPAP., Results: Significantly lower TcCO 2 values were observed during nHFOV compared with nCPAP: 47.5 ± 7.6 versus 49.9 ± 7.2 mmHg, respectively, P = 0.0007. A different TcCO 2 behavior was found according to the random sequence: in patients starting on nCPAP, TcCO 2 significantly decreased from 50.0 ± 8.0 to 46.6 ± 7.5 mmHg during nHFOV (P = 0.001). In patients starting on nHFOV, TcCO 2 slightly increased from 48.5 ± 7.8 to 49.9 ± 6.7 mmHg during nCPAP (P = 0.13)., Conclusions: nHFOV delivered through nasal prongs is more effective than nCPAP in improving the elimination of CO 2 ., (© 2018 Wiley Periodicals, Inc.)

Published
2018
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16. 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 G, Pastorino R, Boni L, Cota F, Carnielli V, Cools F, Dani C, Mosca F, Pillow J, Polglase G, Tagliabue P, van Kaam AH, Ventura ML, Tana M, Tirone C, Aurilia C, Lio A, Ricci C, Gambacorta A, Consigli C, D'Onofrio D, Gizzi C, Massenzi L, Cardilli V, Casati A, Bottino R, Pontiggia F, Ciarmoli E, Martinelli S, Ilardi L, Colnaghi M, Matassa PG, Vendettuoli V, Villani P, Fusco F, 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 M, Nigro G, Del Vecchio A, Petrillo F, Orfeo L, Grappone L, Quartulli L, Scorrano A, Messner H, Staffler A, Gargano G, Balestri E, Nobile S, 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, and Tormena F

Subjects
Caffeine administration & dosage, Central Nervous System Stimulants administration & dosage, Citrates administration & dosage, Continuous Positive Airway Pressure, Female, Humans, Infant, Newborn, Male, Time Factors, Treatment Outcome, Airway Extubation methods, Biological Products administration & dosage, High-Frequency Ventilation methods, Infant, Premature, Intubation, Intratracheal methods, Phospholipids administration & dosage, Pulmonary Surfactants administration & dosage, Respiratory Distress Syndrome, Newborn therapy
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.

Published
2016
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17. Cardiac tamponade and bilateral pleural effusion in a very low birth weight infant.

Author

Haass C, Sorrentino E, Tempera A, Consigli C, De Paola D, Calcagni G, Piastra M, and Finocchi M

Subjects
Cardiac Tamponade therapy, Extravasation of Diagnostic and Therapeutic Materials etiology, Extravasation of Diagnostic and Therapeutic Materials therapy, Female, Humans, Infant, Newborn, Infant, Very Low Birth Weight, Parenteral Nutrition, Pericardiocentesis, Pleural Effusion therapy, Cardiac Tamponade etiology, Catheterization, Central Venous adverse effects, Catheters, Indwelling adverse effects, Extravasation of Diagnostic and Therapeutic Materials complications, Pleural Effusion etiology
Abstract

A very low birth weight premature newborn developed a sudden cardiac tamponade due to parenteral fluid extravasation 1 month after central line insertion. Besides tensive pericardial effusion a bilateral pleural effusion also developed. An emergency pericardiocentesis was really life-saving and after pleural fluid removal a complete cardiorespiratory recovery was obtained. Pericardial and bilateral pleural effusions very rarely coexist as a complication of central line extravasation.

Published
2009
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18. Preoperative administration of controlled-release oxycodone as a transition opioid for total intravenous anaesthesia in pain control after laparoscopic cholecystectomy.

Author

Fanelli G, Ghisi D, Berti M, Troglio R, Ortu A, Consigli C, and Casati A

Subjects
Delayed-Action Preparations administration & dosage, Double-Blind Method, Humans, Middle Aged, Preoperative Care, Prospective Studies, Analgesics, Opioid administration & dosage, Anesthesia, Intravenous, Cholecystectomy, Laparoscopic adverse effects, Oxycodone administration & dosage, Pain, Postoperative etiology, Pain, Postoperative prevention & control
Abstract

Background: The complexity of pain from laparoscopic cholecystectomy and the need for treating incident pain provide rationale for multipharmacological analgesia. We investigated the preoperative administration of controlled-release (CR) oxycodone as transition opioid from remifentanil infusion for pain after laparoscopic cholecystectomy., Methods: Fifty consecutive patients undergoing laparoscopic cholecystectomy were randomly, double-blindly assigned to treatment group (n=25, CR oxycodone: 1 h before surgery and 12 h after the first administration) or to the control group (n=25, placebo: administered at the same intervals). General anaesthesia was maintained with propofol and remifentanil target-controlled infusions (TCIs). All patients received ketorolac 30 mg i.v. Tramadol i.v. was administered for patient-controlled analgesia (PCA) postoperatively. Numerical rating scale for pain at rest and at movement (NRSr and NRSi), tramadol consumption, times to readiness to surgery and awakening, times to modified Aldrete's and modified Post-Anesthetic Discharge Scoring System (PADSS)>9 and side effects were evaluated., Results: All NRSr and NRSi and tramadol consumption were significantly lower in the treatment group. The oxycodone group showed higher modified Aldrete's scores at each time and reached a PADSS>9 faster. Side effects and postoperative nausea and vomiting episodes were comparable., Conclusions: We demonstrated the success of a multipharmacological treatment including opioid premedication with CR oxycodone used as transition opioid for TCI remifentanil infusion; the treatment group showed lower pain scores and rescue analgesic consumption, shorter time to discharge from recovery room and from surgical ward, and the same incidence of side effects, comparably to controls.

Published
2008
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19. [Difluocortolone valerate for topical use in dermatology].

Author

Consigli CA and González W

Subjects
Administration, Topical, Clinical Trials as Topic, Drug Evaluation, Fluocortolone administration & dosage, Humans, Ointments, Valerates therapeutic use, Fluocortolone therapeutic use, Pregnadienediols therapeutic use, Skin Diseases drug therapy
Abstract

59 patients with various skin disorders - most of them in the acute stage - were treated in this trial. The topical investigational preparation was a cream containing 0.1% diflucortolone valerate. The results confirmed that the preparation has a quick-acting and effective antipruritic and antiphlogistic action. The results achieved were good or very good in 91.52% of cases and moderate in 8.47%. No side effects were observed.

Published
1976

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