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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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6. 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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9. 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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10. Safety of Rotavirus Vaccination in Preterm Infants Admitted in Neonatal Intensive Care Units in Sicily, Italy: A Multicenter Observational Study.

Author

Costantino C, Conforto A, Bonaccorso N, Cimino L, Sciortino M, Palermo M, Maiolo K, Tina LG, Betta PM, Caracciolo M, Loretta CM, Arco A, Gitto E, Vitaliti SM, Mancuso D, Vitaliti G, Rosella V, Pinello G, Corsello G, Serra G, Gabriele B, Tramuto F, Restivo V, Amodio E, and Vitale F

Abstract

Rotavirus (RV) is among the most common vaccine-preventable diseases in children under five years of age. Despite the severity of rotavirus pathology in early childhood, rotavirus vaccination for children admitted to the neonatal intensive care unit (NICU), who are often born preterm and with various previous illnesses, is not performed. This multicenter, 3-year project aims to evaluate the safety of RV vaccine administration within the six main neonatal intensive care units of the Sicilian Region to preterm infants. Methods: Monovalent live attenuated anti-RV vaccination (RV1) was administered from April 2018 to December 2019 to preterm infants with gestational age ≥ 28 weeks. Vaccine administrations were performed in both inpatient and outpatient hospital settings as a post-discharge follow-up (NICU setting) starting at 6 weeks of age according to the official immunization schedule. Any adverse events (expected, unexpected, and serious) were monitored from vaccine administration up to 14 days (first assessment) and 28 days (second assessment) after each of the two scheduled vaccine doses. Results : At the end of December 2019, 449 preterm infants were vaccinated with both doses of rotavirus vaccine within the six participating Sicilian NICUs. Mean gestational age in weeks was 33.1 (±3.8 SD) and the first dose of RV vaccine was administered at 55 days (±12.9 SD) on average. The mean weight at the first dose was 3388 (SD ± 903) grams. Only 0.6% and 0.2% of infants reported abdominal colic and fever above 38.5 °C in the 14 days after the first dose, respectively. Overall, 1.9% EAEs were observed at 14 days and 0.4% at 28 days after the first/second dose administration. Conclusions : Data obtained from this study confirm the safety of the monovalent rotavirus vaccine even in preterm infants with gestational age ≥ 28 weeks, presenting an opportunity to improve the vaccination offer both in Sicily and in Italy by protecting the most fragile infants who are more at risk of contracting severe rotavirus gastroenteritis and nosocomial RV infection.

Published
2023
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11. 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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12. Method for calibrating olfactometer output. Part 2. Amyl acetate.

Author

Maiolo KC, Walker JC, and Ogden MW

Subjects
Calibration, Chromatography, Gas, Air Pollutants analysis, Odorants analysis, Pentanols analysis
Abstract

A method for measuring amyl acetate in air was developed and validated. Known volumes of air samples from the output of an olfactometer, a device used to generate odor stimuli, were passed through charcoal sorbent tubes. Following extraction of the sorbent with carbon disulfide, the amount of amyl acetate collected on each tube was determined by gas chromatography with flame ionization detection. The method was used to determine the actual concentrations of amyl acetate presented to experimental participants in odor sensitivity testing.

Published
2000
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