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2 results on '"L. T. Corvaglia"'

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

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

Subjects
Preterm infants, Lung recruitment, HFOV, INRECSURE, LISA, Surfactant, Medicine (General), R5-920
Abstract

Abstract Background Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. Methods In this study, 382 infants born at 24+0–27+6 weeks’ gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks’ postmenstrual age. The secondary outcomes are BPD at 36 weeks’ postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24+0 to 25+6 weeks or 26+0 to 27+6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). Discussion This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24+0–27+6 weeks’ gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks’ postmenstrual age of life. Trial registration ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.

Published
2024
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2. Prognostic value of brain proton MR spectroscopy and diffusion tensor imaging in newborns with hypoxic-ischemic encephalopathy treated by brain cooling

Author

Francesca Sbravati, Sara Grandi, Emil Malucelli, David Neil Manners, Caterina Tonon, Gina Ancora, Claudia Testa, Luigi Corvaglia, Silvia Savini, Laura Ludovica Gramegna, Raffaele Lodi, Giovanni Tani, Giacomo Faldella, G. Ancora, C. Testa, S. Grandi, C. Tonon, F. Sbravati, S. Savini, D. N. Manner, L. L. Gramegna, G. Tani, E. Malucelli, L. T. Corvaglia, G. Faldella, and R. Lodi

Subjects
Male, MRS, medicine.medical_specialty, Neurology, Encephalopathy, Corpus callosum, Sensitivity and Specificity, Hypoxic Ischemic Encephalopathy, White matter, Nuclear magnetic resonance, Fractional anisotropy, medicine, Humans, Radiology, Nuclear Medicine and imaging, Neuroradiology, HYPOTHERMIA, Hypoxic-ischemicencephalopathy, business.industry, Infant, Newborn, Brain, Reproducibility of Results, medicine.disease, Prognosis, Magnetic Resonance Imaging, medicine.anatomical_structure, Diffusion Tensor Imaging, Treatment Outcome, nervous system, DTI, Cryotherapy, Hypoxia-Ischemia, Brain, Female, Neurology (clinical), Protons, Cardiology and Cardiovascular Medicine, Nuclear medicine, business, Biomarkers, Diffusion MRI
Abstract

INTRODUCTION: MRI, proton magnetic resonance spectroscopy (¹H-MRS), and diffusion tensor imaging (DTI) have been shown to be of great prognostic value in term newborns with moderate-severe hypoxic-ischemic encephalopathy (HIE). Currently, no data are available on ¹H-MRS and DTI performed in the subacute phase after hypothermic treatment. The aim of the present study was to assess their prognostic value in newborns affected by moderate-severe HIE and treated with selective brain cooling (BC). METHODS: Twenty infants treated with BC underwent conventional MRI and (1)H-MRS at a mean (SD) age of 8.3 (2.8) days; 15 also underwent DTI. Peak area ratios of metabolites and DTI variables, namely mean diffusivity (MD), axial and radial diffusivity, and fractional anisotropy (FA), were calculated. Clinical outcome was monitored until 2 years of age. RESULTS: Adverse outcome was observed in 6/20 newborns. Both ¹H-MRS and DTI variables showed higher prognostic accuracy than conventional MRI. N-acetylaspartate/creatine at a basal ganglia localisation showed 100% PPV and 93% NPV for outcome. MD showed significantly decreased values in many regions of white and gray matter, axial diffusivity showed the best predictive value (PPV and NPV) in the genu of corpus callosum (100 and 91%, respectively), and radial diffusivity was significantly decreased in fronto white matter (FWM) and fronto parietal (FP) WM. The decrement of FA showed the best AUC (0.94) in the FPWM. CONCLUSION: Selective BC in HIE neonates does not affect the early and accurate prognostic value of ¹H-MRS and DTI, which outperform conventional MRI.

Published
2013

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