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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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3. Long‐term (48 weeks) effectiveness, safety, and tolerability of erenumab in the prevention of high‐frequency episodic and chronic migraine in a real world: Results of the EARLY 2 study

Author

Barbanti P., Aurilia C., Cevoli S., Egeo G., Fofi L., Messina R., Salerno A., Torelli P., Albanese M., Carnevale A., Bono F., D'Amico D., Filippi M., Altamura C., Vernieri F., Colombo B., Frediani F., Mercuri B., D'Onofrio F., Grazzi L., Aguggia M., Pierangeli G., Favoni V., Finocchi C., Di Fiore P., Costa C. M., Brunelli N., Fallacara A., Bertuzzo D., Zucco M., Di Clemente L., Trimboli M., Pascarella A., Manzo L., Barbanti P., Aurilia C., Cevoli S., Egeo G., Fofi L., Messina R., Salerno A., Torelli P., Albanese M., Carnevale A., Bono F., D'Amico D., Filippi M., Altamura C., Vernieri F., Colombo B., Frediani F., Mercuri B., D'Onofrio F., Grazzi L., Aguggia M., Pierangeli G., Favoni V., Finocchi C., Di Fiore P., Costa C.M., Brunelli N., Fallacara A., Bertuzzo D., Zucco M., Di Clemente L., Trimboli M., Pascarella A., Manzo L., Barbanti, Piero, Aurilia, Cinzia, Cevoli, Sabina, Egeo, Gabriella, Fofi, Luisa, Messina, Roberta, Salerno, Antonio, Torelli, Paola, Albanese, Maria, Carnevale, Antonio, Bono, Francesco, D'Amico, Domenico, Filippi, Massimo, Altamura, Claudia, and Vernieri, Fabrizio

Subjects
Adult, Male, Calcitonin Gene-Related Peptide Receptor Antagonist, medicine.medical_specialty, Visual analogue scale, Migraine Disorders, Population, Analgesic, Longitudinal Studie, Sex Factor, Calcitonin gene-related peptide, Antibodies, Monoclonal, Humanized, calcitonin gene-related peptide, Sex Factors, Chronic Migraine, Migraine Disorder, Calcitonin Gene-Related Peptide Receptor Antagonists, Interquartile range, Internal medicine, Outcome Assessment, Health Care, sex, Humans, Medicine, long-term treatment, migraine, Longitudinal Studies, education, allodynia, education.field_of_study, business.industry, Middle Aged, medicine.disease, Italy, Neurology, Tolerability, Migraine, erenumab, Hyperalgesia, Chronic Disease, Female, Neurology (clinical), business, Human
Abstract

Objective: To evaluate the long-term effectiveness, safety, and tolerability of erenumab in a real-world migraine population, looking for putative predictors of responsiveness. Background: Erenumab proved to be effective, safe, and well tolerated in the prevention of episodic migraine (EM) and chronic migraine (CM) in long-term extension studies of double-blind, placebo-controlled trials in patients with no more than two (EM) or three (CM) prior preventive treatment failures. Methods: A 48-week, multicenter, longitudinal cohort real-life study was conducted at 15headache centers across eight Italian regions between December 20, 2018 and July 31, 2020. We considered all consecutive patients with high-frequency episodic migraine (HFEM) or CM aged 18–65years. Each patient was treated with erenumab 70mg, administered monthly. The dose was switched to 140mg in nonresponders and in responders who had become nonresponders for at least 4weeks. Change in monthly migraine days (MMDs) or monthly headache days (MHDs) at Weeks 45–48 compared with baseline was the primary efficacy endpoint. Secondary endpoints encompassed variation in monthly analgesic intake, achievement of a ≥50%, ≥75%, or 100% reduction in migraine or headache days, and any change in the Visual Analogue Scale (VAS) and Headache Impact Test-6 scores (HIT-6) during the same time interval. Results: A total of 242 patients with migraine received at least one dose of erenumab 70mg and were considered for safety analysis, whereas 221 received a monthly erenumab dose for ≥48weeks and were included in the effectiveness and safety analysis set. All patients had previously been treated unsuccessfully with ≥3migraine-preventive medication classes. From baseline to Weeks 45–48, erenumab treatment reduced MMD by 4.3±5.3(mean±SD) in patients with HFEM, and MHD by 12.8±8.9 (mean±SD) in subjects with CM. VAS and HIT-6scores were decreased by 1.8±1.9 (mean±SD) and 12.3±11 (mean±SD) in HFEM, and by 3.0±2.2 (mean±SD) and 13.1±11.2 (mean±SD) in CM. Median monthly analgesic intake passed from 11.0 (interquartile range [IQR] 10.0–13.0) to 5 (IQR 2.0–8.0) in HFEM and from 20.0 (IQR 15.0–30.0) to 6.0 (IQR 3.8–10.0) in CM. The ≥50% responders were 56.1% (32/57) in HFEM and 75.6% (124/164) in CM; ≥75% responders were 31.6% (18/57) and 44.5% (73/164); and 100% responders were 8.8% (5/57) and 1.2% (2/164), respectively. At Week 48, 83.6% (137/164) of patients with CM had reverted to EM. Erenumab was safe and well tolerated. Responsiveness to erenumab was positively associated with cutaneous allodynia (OR: 5.44, 95% CI: 1.52–19.41; p=0.009) in HFEM. In patients with CM, ≥50% responsiveness was positively associated with male sex (OR: 2.99, 95% CI: 1.03–8.7; p=0.044) and baseline migraine frequency (OR: 1.12, 95% CI: 1.05–1.20; p=0.001) and negatively associated with psychiatric comorbidities (OR: 0.37, 95% CI: 0.15–0.87; p=0.023) and prior treatment failures (OR: 0.77, 95% CI: 0.64–0.92; p=0.004). Conclusions: Long-term (48-week) erenumab treatment provides sustained effectiveness, safety, and tolerability in real-life patients with HFEM or CM with ≥3 prior preventive treatment failures. The dose of 140mg was required in most patients along the study and should be taken into consideration as the starting dose. Allodynia (in HFEM), male sex, and baseline migraine frequency (in CM) might represent positive responsiveness predictors. Conversely, psychiatric comorbidities and multiple prior preventive treatment failures could be negative predictors in patients with CM.

Published
2021

4. Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial

Author

Di Polito, A., Del Vecchio, A., Tana, M., Papacci, P., Vento, A. L., Campagnola, B., Celona, S., Cricenti, L., Bastoni, I., Tirone, C., Lio, A., Aurilia, C., Bottoni, A., Paladini, A., Cota, F., Ferrara, P. E., Ronconi, G., Vento, G., Di Polito A., Del Vecchio A., Tana M., Papacci P. (ORCID:0000-0001-8236-7460), Tirone C., Lio A., Aurilia C., Bottoni A. (ORCID:0000-0002-0155-2195), Paladini A., Cota F. (ORCID:0000-0002-9009-3997), Ferrara P. E., Ronconi G., Vento G. (ORCID:0000-0002-8132-5127), Di Polito, A., Del Vecchio, A., Tana, M., Papacci, P., Vento, A. L., Campagnola, B., Celona, S., Cricenti, L., Bastoni, I., Tirone, C., Lio, A., Aurilia, C., Bottoni, A., Paladini, A., Cota, F., Ferrara, P. E., Ronconi, G., Vento, G., Di Polito A., Del Vecchio A., Tana M., Papacci P. (ORCID:0000-0001-8236-7460), Tirone C., Lio A., Aurilia C., Bottoni A. (ORCID:0000-0002-0155-2195), Paladini A., Cota F. (ORCID:0000-0002-9009-3997), Ferrara P. E., Ronconi G., and Vento G. (ORCID:0000-0002-8132-5127)

Abstract

Background: Tactile maneuvers stimulating spontaneous respiratory activity in preterm infants are recommended since birth, but data on how and how often these maneuvers are applied in clinical practice are unknown. In the last years, most preterm newborns with respiratory failure are preferentially managed with non-invasive respiratory support and by stimulating spontaneous respiratory activity from the delivery room and in neonatal intensive care unit (NICU), in order to avoid the risks of intubation and prolonged mechanical ventilation. Methods: Preterm infants with gestational age < 31 weeks not intubated in the delivery room and requiring non-invasive respiratory support at birth will be eligible for the study. They will be randomized and allocated to one of two treatment groups: (1) the study group infants will be subject to the technique of respiratory facilitation within the first 24 h of life, according to the reflex stimulations, by the physiotherapist. The newborn is placed in supine decubitus and a slight digital pressure is exerted on a hemithorax. The respiratory facilitation technique will be performed for about three minutes and repeated for a total of 4/6 times in sequence, three times a day until spontaneous respiratory activity is achieved; thus, no respiratory support is required; (2) the control group infants will take part exclusively in the individualized postural care program. They will perform the technique of respiratory facilitation and autogenous drainage. Objective: To evaluate the efficacy of early respiratory physiotherapy in reducing the incidence of intubation and mechanical ventilation in the first week of life (primary outcome). Discussion: The technique of respiratory facilitation is based on reflex stimulations, applied early to preterm infant. Slight digital pressure is exerted on a “trigger point” of each hemithorax, to stimulate the respiratory activity with subsequent increase of the ipsilateral pulmonary minute ventilation

Published
2021

5. HEADWORK Questionnaire: Why Do We Need a New Tool to Assess Work-Related Disability in Patients With Migraine?

Author

D'Amico D., Grazzi L., Grignani E., Leonardi M., Sansone E., Raggi A., Covelli V., Guastafierro E., Scaratti C., Usai S., Bartolini M., Viticchi G., Cevoli S., Pierangeli G., Tedeschi G., Russo A., Barbanti P., Aurilia C., Lovati C., Giani L., Frediani F., Di Fiore P., Bono F., Rapisarda L., Pascarella A., D'Amico, D., Grazzi, L., Grignani, E., Leonardi, M., Sansone, E., Raggi, A., Covelli, V., Guastafierro, E., Scaratti, C., Usai, S., Bartolini, M., Viticchi, G., Cevoli, S., Pierangeli, G., Tedeschi, G., Russo, A., Barbanti, P., Aurilia, C., Lovati, C., Giani, L., Frediani, F., Di Fiore, P., Bono, F., Rapisarda, L., Pascarella, A., D'Amico D., Grazzi L., Grignani E., Leonardi M., Sansone E., Raggi A., Covelli V., Guastafierro E., Scaratti C., Usai S., Bartolini M., Viticchi G., Cevoli S., Pierangeli G., Tedeschi G., Russo A., Barbanti P., Aurilia C., Lovati C., Giani L., Frediani F., Di Fiore P., Bono F., Rapisarda L., and Pascarella A.

Subjects
Adult, Gerontology, medicine.medical_specialty, disability evaluation, Migraine Disorders, Severity of Illness Index, Work related, 03 medical and health sciences, Indirect costs, 0302 clinical medicine, Chronic Migraine, work, Surveys and Questionnaires, Epidemiology, Humans, Medicine, Disabled Persons, In patient, 030212 general & internal medicine, Sensitivity to change, HEADWORK, business.industry, medicine.disease, Clinical trial, Neurology, Migraine, employment, episodic migraine, Neurology (clinical), chronic migraine, business, 030217 neurology & neurosurgery
Abstract

Objective: This article reviews current headache disability measures and clinical need, as well as presenting the rationale for a new measure addressing work-related disability in migraine patients and the steps devoted to this aim. Background: Episodic and chronic migraine (EM and CM) constitute an enormous economic burden to societies, and the vast majority of this burden is attributable to indirect costs, ie those associated with productivity loss. A measure of work-related disability is therefore needed to quantify the impact of EM and CM on patients' ability to carry out work tasks. Methods: We briefly present the advantages and disadvantages of the disability measures that have been most commonly used for this purpose and the rationale for developing a new measure. Results: The entire process of development of HEADWORK, a questionnaire designed to assess work-related disability, is presented together with short-term sensitivity to change. Conclusions: Current headache disability measures need improvement. HEADWORK is a valid, reliable, and sensitive questionnaire to address the amount and severity of work-related difficulties and of the factors contributing to such difficulties. HEADWORK is suitable for daily clinical practice, epidemiological research and for clinical trials, and potentially to define work-related disability weights for the calculation of migraine indirect costs.

Published
2020

10. Oxidative and Proteolytic Inactivation of Alpha-1 Antitrypsin in Bronchopulmonary Dysplasia Pathogenesis: A Top-Down Proteomic Bronchoalveolar Lavage Fluid Analysis

Author

Tirone, Chiara, Iavarone, Federica, Tana, Milena, Lio, Alessandra, Aurilia, Claudia, Costa, Simonetta, Castagnola, Massimo, Messana, Irene, Vento, Giovanni, Tirone C., Iavarone F. (ORCID:0000-0002-2074-5531), Tana M., Lio A., Aurilia C., Costa S., Castagnola M. (ORCID:0000-0002-0959-7259), Messana I. (ORCID:0000-0002-1436-6105), Vento G. (ORCID:0000-0002-8132-5127), Tirone, Chiara, Iavarone, Federica, Tana, Milena, Lio, Alessandra, Aurilia, Claudia, Costa, Simonetta, Castagnola, Massimo, Messana, Irene, Vento, Giovanni, Tirone C., Iavarone F. (ORCID:0000-0002-2074-5531), Tana M., Lio A., Aurilia C., Costa S., Castagnola M. (ORCID:0000-0002-0959-7259), Messana I. (ORCID:0000-0002-1436-6105), and Vento G. (ORCID:0000-0002-8132-5127)

Abstract

The study investigates the role of the oxidative and proteolytic inactivation of alpha-1 antitrypsin (AAT) in the pathogenesis of bronchopulmonary dysplasia (BPD) in premature infants. Bronchoalveolar lavage fluid (BALF) samples were collected on the 3rd day of life from mechanically ventilated neonates with gestational age ≤ 30 weeks and analyzed without previous treatment (top-down proteomics) by reverse-phase high-performance liquid chromatography-electrospray ionization mass spectrometry. AAT fragments were identified by high-resolution LTQ Orbitrap XL experiments and the relative abundances determined by considering the extracted ion current (XIC) peak area. Forty preterm neonates were studied: 20 (50%) did not develop BPD (no-BPD group), 17 (42.5%) developed mild or moderate new-BPD (mild + moderate BPD group), and 3 (7.5%) developed severe new-BPD (severe BPD group). Eighteen fragments of AAT and a fragment of AAT oxidized at a methionine residue were identified: significantly higher values of AAT fragments 25–57, 375–418, 397–418, 144–171, and 397–418 with oxidized methionine were found in the severe BPD group. The significantly higher levels of several AAT fragments and of the fragment 397–418, oxidized in BALF of preterm infants developing BPD, underlie the central role of an imbalance between proteases and protease inhibitors in exacerbating lung injury and inducing most severe forms of BPD. The study has some limitations, and between them, the small sample size implies the need for further confirmation by larger studies.

Published
2021

11. 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

12. Complications associated with myocardial bridging in four children without underlying cardiac disease: a case series

Author

Brancato, F., Rigante, Donato, Piastra, Marco, Gambacorta, Maria Antonietta, Aurilia, Claudia, De Rosa, Gabriella, Rigante D. (ORCID:0000-0001-7032-7779), Piastra M. (ORCID:0000-0002-3144-8970), Gambacorta A. (ORCID:0000-0001-5455-8737), Aurilia C., De Rosa G. (ORCID:0000-0002-8780-5105), Brancato, F., Rigante, Donato, Piastra, Marco, Gambacorta, Maria Antonietta, Aurilia, Claudia, De Rosa, Gabriella, Rigante D. (ORCID:0000-0001-7032-7779), Piastra M. (ORCID:0000-0002-3144-8970), Gambacorta A. (ORCID:0000-0001-5455-8737), Aurilia C., and De Rosa G. (ORCID:0000-0002-8780-5105)

Abstract

Background: Myocardial bridging is largely considered to be a benign, symptomless congenital anomaly of the coronary arteries in which the intramyocardial coronary course is partially ‘tunnelled’ and leads to vessel compression during ventricular systole. There are few data regarding children. Objective: To report on myocardial bridging observed in children seeking medical help in the paediatric emergency room. Case presentation: A series of four children aged 6–13 years with symptomatic myocardial bridging but no other underlying cardiac abnormalities is reported. They were admitted to the paediatric emergency department during 2013–2016, three with chest pain after physical activity and one with septic shock. Results: Heart computed tomography scan in the first three demonstrated myocardial bridging of the left anterior descendent coronary artery’s branches; their 2-year follow-up was uneventful. The fourth patient presented with ventricular fibrillation 24 hours after admission and at autopsy there was an intramyocardial tract 4 cm long on the left anterior descendent coronary artery. Conclusions: This case series demonstrates that myocardial bridging can be symptomatic in children with no underlying cardiac disorders and should be included in the differential diagnosis of exertional chest pain and/or arrhythmias. Abbreviations: CRP, C-reactive protein; CT, computed tomography; D1, diagonal 1 artery; ECG, electrocardiogram; ED, emergency department; KD, Kawasaki disease; LAD, left anterior descending coronary artery; MB, myocardial bridging; RI, ramus intermedius artery; TN, troponin.

Published
2021

14. Practical and clinical utility of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: a post hoc analysis of the randomized, sham-controlled, double-blind PRESTO trial

Author

Licia GrazziEmail author, Cristina, Tassorelli, Marina de Tommaso, Giulia, Pierangeli, Paolo, Martelletti, Rainero, Innocenzo, Pierangelo, Geppetti, Anna, Ambrosini, Paola, Sarchielli, Eric, Liebler, Tassorelli C, Piero Barbanti PRESTO Study Group., Bitetto, V, De Icco, R, Martinelli, D, Sances, G, Bianchi, M, Grazzi, L, Padovan, Am, de Tommaso, M, Ricci, K, Vecchio, E, Cortelli, P, Cevoli, S, Pierangeli, G, Terlizzi, R, Martelletti, P, Negro, A, Chiariello, Ga, Rainero, I, De Martino, P, Gai, A, Govone, F, Masuzzo, F, Rubino, E, Torrieri, Mc, Vacca, A, Geppetti, P, Chiarugi, A, De Cesaris, F, Puma, Sl, Lupi, C, Marone, I, Ambrosini, A, Perrotta, A, Sarchielli, P, Bernetti, L, Corbelli, I, Romoli, M, Simoni, S, Verzina, A, Barbanti, P, Aurilia, C, Egeo, G, Fofi, L, Liebler, E, Andersson, A, Spitzer, L, Marin, J, Mcclure, C, Thackeray, L, Baldi, Mg, Di Maro, D., Grazzi, Licia, Tassorelli, Cristina, De Tommaso, Marina, Pierangeli, Giulia, Martelletti, Paolo, Rainero, Innocenzo, Geppetti, Pierangelo, Ambrosini, Anna, Sarchielli, Paola, Liebler, Eric, Barbanti, Piero, PRESTO Study Group, and Cortelli, Pietro

Subjects
Male, Neurology, medicine.medical_treatment, lcsh:Medicine, 0302 clinical medicine, Migraine Disorder, Prospective Studies, 030212 general & internal medicine, Rescue medication, neurology (clinical), Neuromodulation, General Medicine, Middle Aged, Treatment Outcome, Anesthesia, Acute Disease, Female, Vagus nerve stimulation, Research Article, Human, Adult, Migraine, Pain intensity, Post hoc analysis, medicine.medical_specialty, Migraine Disorders, anesthesiology and Pain Medicine, Double blind, 03 medical and health sciences, Double-Blind Method, Post-hoc analysis, medicine, Humans, Post hoc analysi, business.industry, migraine, neuromodulation, pain intensity, post hoc analysis, rescue medication, vagus nerve stimulation, Non invasive, lcsh:R, Correction, Self Care, Vagus Nerve Stimulation, Neurology (clinical), Anesthesiology and Pain Medicine, medicine.disease, Prospective Studie, Self care, business, 030217 neurology & neurosurgery
Abstract

Background The PRESTO study of non-invasive vagus nerve stimulation (nVNS; gammaCore®) featured key primary and secondary end points recommended by the International Headache Society to provide Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 h post stimulation. Here, we examined additional data from PRESTO to provide further insights into the practical utility of nVNS by evaluating its ability to consistently deliver clinically meaningful improvements in pain intensity while reducing the need for rescue medication. Methods Patients recorded pain intensity for treated migraine attacks on a 4-point scale. Data were examined to compare nVNS and sham with regard to the percentage of patients who benefited by at least 1 point in pain intensity. We also assessed the percentage of attacks that required rescue medication and pain-free rates stratified by pain intensity at treatment initiation. Results A significantly higher percentage of patients who used acute nVNS treatment (n = 120) vs sham (n = 123) reported a ≥ 1-point decrease in pain intensity at 30 min (nVNS, 32.2%; sham, 18.5%; P = 0.020), 60 min (nVNS, 38.8%; sham, 24.0%; P = 0.017), and 120 min (nVNS, 46.8%; sham, 26.2%; P = 0.002) after the first attack. Similar significant results were seen when assessing the benefit in all attacks. The proportion of patients who did not require rescue medication was significantly higher with nVNS than with sham for the first attack (nVNS, 59.3%; sham, 41.9%; P = 0.013) and all attacks (nVNS, 52.3%; sham, 37.3%; P = 0.008). When initial pain intensity was mild, the percentage of patients with no pain after treatment was significantly higher with nVNS than with sham at 60 min (all attacks: nVNS, 37.0%; sham, 21.2%; P = 0.025) and 120 min (first attack: nVNS, 50.0%; sham, 25.0%; P = 0.018; all attacks: nVNS, 46.7%; sham, 30.1%; P = 0.037). Conclusions This post hoc analysis demonstrated that acute nVNS treatment quickly and consistently reduced pain intensity while decreasing rescue medication use. These clinical benefits provide guidance in the optimal use of nVNS in everyday practice, which can potentially reduce use of acute pharmacologic medications and their associated adverse events. Trial registration ClinicalTrials.gov identifier: NCT02686034.

Published
2018

15. 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

16. 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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20. Gut and Lung Microbiota in Preterm Infants: Immunological Modulation and Implication in Neonatal Outcomes.

Author

Tirone, C, Pezza, Lucilla, Paladini, A, Tana, M, Aurilia, C, Lio, A, D'Ippolito, Silvia, Tersigni, Chiara, Posteraro, Brunella, Sanguinetti, Maurizio, Di Simone, Nicoletta, Vento, Giovanni, Pezza L, D'Ippolito S (ORCID:0000-0002-6160-0558), Tersigni C, Posteraro B (ORCID:0000-0002-1663-7546), Sanguinetti M (ORCID:0000-0002-9780-7059), Di Simone N (ORCID:0000-0003-1273-3335), Vento G. (ORCID:0000-0002-8132-5127), Tirone, C, Pezza, Lucilla, Paladini, A, Tana, M, Aurilia, C, Lio, A, D'Ippolito, Silvia, Tersigni, Chiara, Posteraro, Brunella, Sanguinetti, Maurizio, Di Simone, Nicoletta, Vento, Giovanni, Pezza L, D'Ippolito S (ORCID:0000-0002-6160-0558), Tersigni C, Posteraro B (ORCID:0000-0002-1663-7546), Sanguinetti M (ORCID:0000-0002-9780-7059), Di Simone N (ORCID:0000-0003-1273-3335), and Vento G. (ORCID:0000-0002-8132-5127)

Abstract

In recent years, an aberrant gastrointestinal colonization has been found to be associated with an higher risk for postnatal sepsis, necrotizing enterocolitis (NEC) and growth impairment in preterm infants. As a consequence, the reasons of intestinal dysbiosis in this population of newborns have increasingly become an object of interest. The presence of a link between the gut and lung microbiome's development (gut-lung axis) is emerging, and more data show as a gut-brain cross talking mediated by an inflammatory milieu, may affect the immunity system and influence neonatal outcomes. A revision of the studies which examined gut and lung microbiota in preterm infants and a qualitative analysis of data about characteristic patterns and related outcomes in terms of risk of growing impairment, Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia (BPD), and sepsis have been performed. Microbiota take part in the establishment of the gut barrier and many data suggest its immune-modulator role. Furthermore, the development of the gut and lung microbiome (gut-lung axis) appear to be connected and able to lead to abnormal inflammatory responses which have a key role in the pathogenesis of BPD. Dysbiosis and the gut predominance of facultative anaerobes appear to be crucial to the pathogenesis and subsequently to the prevention of such diseases.

Published
2019

23. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study

Author

Tassorelli, C, Grazzi, L, de Tommaso, M, Pierangeli, G, Martelletti, P, Rainero, I, Dorlas, S, Geppetti, P, Ambrosini, A, Sarchielli, P, Liebler, E, Barbanti, P, PRESTO Study Group (Tassorelli, C, Bitetto, V, De Icco, R, Martinelli, D, Sances, Giuseppe, Bianchi, M, Padovan, Anna Maria, Ricci, Katia Ivana, Vecchio, E, Cortelli, Pietro, Cevoli, S, Terlizzi, R, Negro, A, Chiariello, Ga, De Martino, P, Gai, A, Govone, F, Masuzzo, Federica, Rubino, E, Torrieri, MARIA CLAUDIA, Vacca, A, Chiarugi, A, De Cesaris, F, Puma, Sl, Lupi, C, Marone, Isabella, Perrotta, A, Bernetti, L, Corbelli, I, Romoli, M, Simoni, S, Verzina, A, Aurilia, C, Egeo, G, Fofi, L, Andersson, A, Spitzer, L, MARIN ACUNA, JANET MILAGROS, Mcclure, C, Thackerey, L, Baldi, Mg, Di Maro, D. )., Tassorelli, Cristina, Grazzi, Licia, de Tommaso, Marina, Pierangeli, Giulia, Martelletti, Paolo, Rainero, Innocenzo, Dorlas, Stefanie, Geppetti, Pierangelo, Ambrosini, Anna, Sarchielli, Paola, Liebler, Eric, Barbanti, Piero, and Cortelli, Pietro

Subjects
Male, Aura, triptans serotonin, medicine.medical_treatment, diclofenac potassium, efficacy, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Clinical endpoint, Medicine, migraine, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, 5-ht1b/1d agonists, Pain Measurement, Middle Aged, Treatment Outcome, Tolerability, controlled-trial, Anesthesia, Female, double-blind, headache, Vagus nerve stimulation, Adult, Vagus Nerve Stimulation, Migraine Disorders, open-label, Article, 03 medical and health sciences, Double-Blind Method, prevention ampp, vagus nerve, Humans, tolerability, migraine therapy, neurology (clinical), business.industry, Odds ratio, medicine.disease, Migraine, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

ObjectiveTo evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.MethodsA total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes.ResultsnVNS (n = 120) was superior to sham (n = 123) for pain freedom at 30 minutes (12.7% vs 4.2%; p = 0.012) and 60 minutes (21.0% vs 10.0%; p = 0.023) but not at 120 minutes (30.4% vs 19.7%; p = 0.067; primary endpoint; logistic regression) after the first treated attack. A post hoc repeated-measures test provided further insight into the therapeutic benefit of nVNS through 30, 60, and 120 minutes (odds ratio 2.3; 95% confidence interval 1.2, 4.4; p = 0.012). nVNS demonstrated benefits across other endpoints including pain relief at 120 minutes and was safe and well-tolerated.ConclusionThis randomized sham-controlled trial supports the abortive efficacy of nVNS as early as 30 minutes and up to 60 minutes after an attack. Findings also suggest effective pain relief, tolerability, and practicality of nVNS for the acute treatment of episodic migraine.ClinicalTrials.gov identifierNCT02686034.Classification of evidenceThis study provides Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 hours poststimulation (absolute difference 13.2%).

Published
2018

24. Transient hypopigmentation in a black preterm newborn managed with Tegaderm®.

Author

De Rose, D. U., Barone, Giovanni, Aurilia, Claudia, Frezza, Simonetta, Gallini, Francesca, Barone G., Aurilia C., Frezza S. (ORCID:0000-0001-9314-7818), Gallini F. (ORCID:0000-0002-9510-8481), De Rose, D. U., Barone, Giovanni, Aurilia, Claudia, Frezza, Simonetta, Gallini, Francesca, Barone G., Aurilia C., Frezza S. (ORCID:0000-0001-9314-7818), and Gallini F. (ORCID:0000-0002-9510-8481)

Abstract

The transepidermal water loss is high in the newborn with a very low weight (ELBW) at birth. Recent studies show that the use of Tegaderm® in the ELBW newborn significantly reduces the problems resulting from the loss of water through the epidermis. A hypopigmentation secondary to the use of Tegaderm® was described.

Published
2018

25. Extubation from high-frequency oscillatory ventilation in extremely low birth weight infants: A prospective observational study

Author

Tana, M., Lio, A., Tirone, C., Aurilia, C., Tiberi, Eloisa, Serrao, F., Purcaro, Velia, Corsello, M., Catenazzi, P., D'Andrea, Vito, Barone, G., Ricci, C., Pastorino, Roberta, Vento, Giovanni, Tiberi E., Purcaro V., D'Andrea V. (ORCID:0000-0002-0980-799X), Pastorino R. (ORCID:0000-0001-5013-0733), Vento G. (ORCID:0000-0002-8132-5127), Tana, M., Lio, A., Tirone, C., Aurilia, C., Tiberi, Eloisa, Serrao, F., Purcaro, Velia, Corsello, M., Catenazzi, P., D'Andrea, Vito, Barone, G., Ricci, C., Pastorino, Roberta, Vento, Giovanni, Tiberi E., Purcaro V., D'Andrea V. (ORCID:0000-0002-0980-799X), Pastorino R. (ORCID:0000-0001-5013-0733), and Vento G. (ORCID:0000-0002-8132-5127)

Abstract

Objective To evaluate if weaning from high-frequency oscillatory ventilation (HFOV) directly to a non-invasive mode of respiratory support is feasible and results in successful extubation in extremely low birth weight (ELBW) infants. Design Prospective observational study. Setting Tertiary neonatal intensive care unit. Patients One hundred and eight ELBW infants of 26.2±1.4 weeks of gestational age (GA) directly extubated from HFOV. Interventions All infants were managed with elective HFOV and received surfactant after a recruitment HFOV manoeuvre. Extubation was attempted at mean airways pressure (MAP) ≤6 cm H 2 O with FiO 2 ≤0.25. After extubation, all infants were supported by nasal continuous positive airway pressure (6-8 cm H 2 O). Main outcome measures Extubation failure (clinical deterioration requiring reintubation) was defined as shorter than 7 days. Results Ninety patients (83%) were successfully extubated and 18 (17%) required reintubation. No significant differences were found between the two groups in terms of birth weight, day of life and weight at the time of extubation. Multivariable analysis showed that GA (OR 1.71; 95% CI 1.04, 2.08) and higher MAP prior to surfactant (OR 1.51; 95% CI 1.06, 2.15) were associated with successful extubation. Conclusions In ELBW infants, direct extubation from HFOV at MAP ≤6 cm H 2 O with FiO 2 ≤0.25 is feasible. Our extubation success rate (83%) is higher than conventional mechanical ventilation in this very vulnerable class of infants.

Published
2018

26. Ventilation prior to umbilical cord clamping improves cardiovascular stability and oxygenation in preterm lambs after exposure to intrauterine inflammation

Author

Lio, A., Aurilia, C., Zahra, V., Moss, T. J., LaRosa, D. A., Hooper, S. B., Gill, A. W., Kluckow, M., Nitsos, I., Vento, G., Polglase, G. R., Vento G. (ORCID:0000-0002-8132-5127), Lio, A., Aurilia, C., Zahra, V., Moss, T. J., LaRosa, D. A., Hooper, S. B., Gill, A. W., Kluckow, M., Nitsos, I., Vento, G., Polglase, G. R., and Vento G. (ORCID:0000-0002-8132-5127)

Abstract

Background: Delaying umbilical cord clamping until after aeration of the lung (physiological-based cord clamping; PBCC) maintains cardiac output and oxygenation in preterm lambs at birth, however, its efficacy after intrauterine inflammation is not known. Given the high incidence of chorioamnionitis in preterm infants, we investigated whether PBCC conferred any benefits compared to immediate cord clamping (ICC) in preterm lambs exposed antenatally to 7 days of intrauterine inflammation. Methods: Ultrasound guided intraamniotic injection of 20 mg Lipopolysaccharide (from E. coli:055:B5) was administered to pregnant ewes at 0.8 gestation. Seven days later, ewes were anesthetized, preterm fetuses exteriorised via cesarean section, and instrumented for continuous measurement of pulmonary, systemic and cerebral pressures and flows, and systemic, and cerebral oxygenation. Lambs were then randomized to either PBCC, whereupon ventilation was initiated and maintained for 3 min prior to umbilical cord clamping, or ICC where the umbilical cord was cut and ventilation initiated 30 s later. Ventilation was maintained for 30 min. Results: ICC caused a rapid fall in systemic (by 25%) and cerebral (by 11%) oxygen saturation in ICC lambs, concurrent with a rapid increase in carotid arterial pressure and heart rate. The overshoot in carotid arterial pressure was sustained in ICC lambs for the first 20 min of the study. PBCC maintained cardiac output and prevented the fall in cerebral oxygen delivery at birth. PBCC lambs had lower respiratory compliance and higher respiratory requirements throughout the study. Conclusion: PBCC mitigated the adverse effects of ICC on oxygenation and cardiac output, and therefore could be more beneficial in preterm babies exposed to antenatal inflammation as it maintains cardiac output and oxygen delivery. The increased respiratory requirements require further investigation in this sub-group of preterm infants.

Published
2018

27. 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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28. Risk factors for bronchiolitis hospitalization during the first year of life in a multicenter Italian birth cohort

Author

Lanari M, Prinelli F, Adorni F, Di Santo S, Vandini S, Silvestri M, Musicco M, Faldella G, Spinelli M, Corsello G, Gabriele B, La Forgia N, Loprieno S, Boldrini A, Vuerich M, Del Vecchio A, Bertino E, Fabris C, Coscia A, Fanos V, Puddu M, Gargano G, Braibanti S, Corso G, Orfeo L, De Luca MG, Paolillo P, Fabiano A, Barberi I, Arco A, Barboni G, Molinari L, Bonomi A, Ladetto L, Carlucci A, Zorzi G, Dall’Agnola A, Girardi E, Di Fabio S, Faccia P, Bottau P, Macagno F, Ellero S, Magaldi R, Rinaldi M, Memo L, Nicolini G, Ngalikpima CJ, Nosari N, Sarnelli P, Parmigiani S, Agosti M, Negri C, Corona MF, Piano F, Scarcella A, Umbaldo A, De Curtis M, Natale F, Aurilia C, Romagnoli C, Lanari, Marcello, Prinelli, Federica, Adorni, Fulvio, Di Santo, Simona, Vandini, Silvia, Silvestri, Michela, Musicco, Massimo, and Lanari M, Prinelli F, Adorni F, Di Santo S, Vandini S, Silvestri M, Musicco M, Faldella G, Spinelli M, Corsello G, Gabriele B, La Forgia N, Loprieno S, Boldrini A, Vuerich M, Del Vecchio A, Bertino E, Fabris C, Coscia A, Fanos V, Puddu M, Gargano G, Braibanti S, Corso G, Orfeo L, De Luca MG, Paolillo P, Fabiano A, Barberi I, Arco A, Barboni G, Molinari L, Bonomi A, Ladetto L, Carlucci A, Zorzi G, Dall’Agnola A, Girardi E, Di Fabio S, Faccia P, Bottau P, Macagno F, Ellero S, Magaldi R, Rinaldi M, Memo L, Nicolini G, Ngalikpima CJ, Nosari N, Sarnelli P, Parmigiani S, Agosti M, Negri C, Corona MF, Piano F, Scarcella A, Umbaldo A, De Curtis M, Natale F, Aurilia C, Romagnoli C

Subjects
Palivizumab, Male, Pediatrics, medicine.medical_specialty, Multivariate analysis, Gestational Age, Respiratory Syncytial Virus Infections, Respiratory syncytial virus, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Sex Factors, Risk Factors, 030225 pediatrics, medicine, Bronchiolitis, Viral, Humans, 030212 general & internal medicine, Bronchiolitis, Children, Hospitalization, Prophylaxis, Risk factor, Breast Feeding, Crowding, Female, Infant, Infant, Newborn, Italy, Multivariate Analysis, Pediatrics, Perinatology and Child Health, Viral, Bronchiolitis, Hospitalization, Risk factor, Respiratory syncytial virus, Prophylaxis, Palivizumab, Children, business.industry, Research, Gestational age, Perinatology and Child Health, medicine.disease, Newborn, 3. Good health, Gestation, business, Breast feeding, medicine.drug, Cohort study
Abstract

Background: Respiratory Syncytial Virus (RSV) is one of the main causes of respiratory infections during the first year of life. Very premature infants may contract more severe diseases and 'late preterm infants' may also be more susceptible to the infection. The aim of this study is to evaluate the risk factors for hospitalization during the first year of life in children born at different gestational ages in Italy. Methods: A cohort of 33-34 weeks gestational age (wGA) newborns matched by sex and age with two cohort of newborns born at 35-37 wGA and >37 wGA were enrolled in this study for a three-year period (2009-2012). Hospitalization for bronchiolitis (ICD-9 code 466.1) during the first year of life was assessed through phone interview at the end of the RSV season (November-March) and at the completion of the first year of life. Results: The study enrolled 2314 newborns, of which 2210 (95.5 %) had a one year follow-up and were included in the analysis; 120 (5.4 %) were hospitalized during the first year of life for bronchiolitis. Children born at 33-34 wGA had a higher hospitalization rate compared to the two other groups. The multivariate analysis carried out on the entire population associated the following factors with higher rates for bronchiolitis hospitalization: male gender; prenatal treatment with corticosteroids; prenatal exposure to maternal smoking; singleton delivery; respiratory diseases in neonatal period; surfactant therapy; lack of breastfeeding; siblings

Published
2015

29. Prenatal tobacco smoke exposure increases hospitalizations for bronchiolitis in infants

Author

Lanari M, Vandini S, Adorni F, Prinelli F, Di Santo S, Silvestri M, Musicco M, ' Faldella G, Spinelli M, Corsello G, La Forgia N, Loprieno S, Boldrini A, Vuerich M, Del Vecchio A, Fabris C, Bertino E, Gaudino M, Coscia A, Fanos V, Puddu M, Gargano G, Braibanti S, Corso G, Orfeo L, De Luca MG, Paolillo P, Fabiano A, Barberi I, Barboni G, Molinari L, Bonomi A, Ladetto L, Carlucci A, Zorzi G, De Curtis M, Natale F, Di Fabio S, Faccia P, Bottau P, Macagno F, Ellero S, Magaldi R, Rinaldi M, Memo L, Nicolini G, Ngalikpima CJ, Nosari N, Sarnelli P, Parmigiani S, Agosti M, Negri C, Corona MF, Piano F, Umbaldo A, Dall’Agnola A, Girardi E, Gabriele B, Aurilia C, Romagnoli C, Lanari M, Vandini S, Adorni F, Prinelli F, Di Santo S, Silvestri M, Musicco M, ' Faldella G, Spinelli M, Corsello G, La Forgia N, Loprieno S, Boldrini A, Vuerich M, Del Vecchio A, Fabris C, Bertino E, Gaudino M, Coscia A, Fanos V, Puddu M, Gargano G, Braibanti S, Corso G, Orfeo L, De Luca MG, Paolillo P, Fabiano A, Barberi I, Barboni G, Molinari L, Bonomi A, Ladetto L, Carlucci A, Zorzi G, De Curtis M, Natale F, Di Fabio S, Faccia P, Bottau P, Macagno F, Ellero S, Magaldi R, Rinaldi M, Memo L, Nicolini G, Ngalikpima CJ, Nosari N, Sarnelli P, Parmigiani S, Agosti M, Negri C, Corona MF, Piano F, Umbaldo A, Dall’Agnola A, Girardi E, Gabriele B, Aurilia C, Romagnoli C, Lanari, Marcello, Vandini, Silvia, Adorni, Fulvio, Prinelli, Federica, Di Santo, Simona, Silvestri, Michela, and Musicco, Massimo

Subjects
Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Pediatrics, Time Factors, Time Factor, Offspring, Longitudinal Studie, Risk Assessment, Tobacco smoke exposure, Pregnancy, Infant, Bronchiolitis, Hospitalization, Risk factor, Bronchiolitis, Hospitalization, Infant, Pregnancy, Risk factor, Tobacco smoke exposure, Age Factors, Female, Humans, Infant, Newborn, Inhalation Exposure, Italy, Longitudinal Studies, Maternal Exposure, Risk Factors, Smoking, Tobacco Smoke Pollution, Prenatal Exposure Delayed Effects, medicine, Age Factor, Bronchioliti, Intensive care medicine, Inhalation exposure, business.industry, Research, Gestational age, Newborn, medicine.disease, Risk assessment, business, Human, Cohort study
Abstract

Background Tobacco smoke exposure (TSE) is a worldwide health problem and it is considered a risk factor for pregnant women’s and children’s health, particularly for respiratory morbidity during the first year of life. Few significant birth cohort studies on the effect of prenatal TSE via passive and active maternal smoking on the development of severe bronchiolitis in early childhood have been carried out worldwide. Methods From November 2009 to December 2012, newborns born at ≥33 weeks of gestational age (wGA) were recruited in a longitudinal multi-center cohort study in Italy to investigate the effects of prenatal and postnatal TSE, among other risk factors, on bronchiolitis hospitalization and/or death during the first year of life. Results Two thousand two hundred ten newborns enrolled at birth were followed-up during their first year of life. Of these, 120 (5.4 %) were hospitalized for bronchiolitis. No enrolled infants died during the study period. Prenatal passive TSE and maternal active smoking of more than 15 cigarettes/daily are associated to a significant increase of the risk of offspring children hospitalization for bronchiolitis, with an adjHR of 3.5 (CI 1.5–8.1) and of 1.7 (CI 1.1–2.6) respectively. Conclusions These results confirm the detrimental effects of passive TSE and active heavy smoke during pregnancy for infants’ respiratory health, since the exposure significantly increases the risk of hospitalization for bronchiolitis in the first year of life. Electronic supplementary material The online version of this article (doi:10.1186/s12931-015-0312-5) contains supplementary material, which is available to authorized users.

Published
2015

32. The multicenter Italian birth cohort study on incidence and determinants of lower respiratory tract infection hospitalization in infants at 33 weeks GA or more: preliminary results

Author

Lanari, M, Adorni, F, Silvestri, M, Coscia, A, Musicco, M, Carlucci, A, Zorzi, G, Di Fabio, S, Faccia, P, La Forgia, N, Loprieno, S, Del Vecchio, A, Corso, G, Orfeo, L, De Luca MG, Faldella, G, Spinelli, M, Bottau, P, Fanos, V, Puddu, M, Rinaldi, M, Barberi, Ignazio, Pagano, Giuseppina, Scarcella, A, Umbaldo, A, Corsello, G, Gabriele, B, Barboni, G, Molinari, L, Boldrini, A, Vuerich, M, Ngalikpima, Cj, Gargano, G, Braibanti, S, Romagnoli, C, Aurilia, C, Paolillo, P, Picone, S, De Curtis, M, Natale, F, Romeo, N, Piano, F, Nosari, N, Sarnelli, P, Parmigiani, S, Corona, Mf, Fabris, C, Gaudino, M, Manzoni, P, Bonomi, A, Ladetto, L, Memo, L, Nicolini, G, Macagno, F, Roadaro, E, Dall'Agnola, A, and Zardini, F.

Published
2011

33. Brain-derived neurotrophic factor: a genetic risk factor for dystonia?

Author

Martino, D., Muglia, M., Abbruzzese, Giovanni, Aniello, M. S., Aurilia, C., Bentivoglio, A. R., Berardelli, A., Eleopra, R., Esposito, M., Gambarin, M., Ghirlanda, P., Guidubaldi, A., Liguori, R., Marinelli, Lucio, Morgante, F., Sabetta, A., Santoro, L., Sprovieri, T., Squintani, G., Tinazzi, M., and Defazio, G.

Published
2007

34. Pramipexole in Parkinson's disease. A short-term study using the combined levodopa-dopamine agonist test

Author

Fabbrini G, Barbanti P, Aurilia C, Caterina Pauletti, and Meco G

Subjects
Male, Receptors, Dopamine D2, Movement, Receptors, Dopamine D3, Parkinson Disease, Antiparkinson Agents, Levodopa, Benserazide, Thiazoles, Pramipexole, Dopamine Agonists, Humans, Drug Therapy, Combination, Female, Benzothiazoles, dopamine agonists, levodopa, parkinson's disease, pramipexole, Aged
Abstract

The aim of our study was to investigate the efficacy of pramipexole in advanced parkinsonian patients by means of an acute stimulation test. We studied the motor effects of pramipexole in fluctuating parkinsonian patients by comparing the response to acute levodopa with the response to levodopa + pramipexole. The adjunct of pramipexole to levodopa increased the time spent on from 136 +/- 22.3 to 186 +/- 20.6 minutes (p0.01), while it did not change the latency to on, the magnitude of the motor improvement, or the duration and severity of dyskinesias. The main effect of pramipexole in fluctuating parkinsonian patients is an increased duration of the on phase.

Published
2003

39. A47 Breastfeeding protects infants against lower respiratory tract infections caused by respiratory syncytial virus. Results from the Italian Cohort Study Group on RSV

Author

Prinelli, F., primary, Musico, M., additional, Adorni, F., additional, Silvestri, M., additional, Coscia, A., additional, Carlucci, A., additional, Zorzi, G., additional, Di Fabio, S., additional, Faccia, P., additional, LaForgia, N., additional, Loprieno, S., additional, Del Vecchio, A., additional, Corso, G., additional, Orfeo, L., additional, De Luca, M.G., additional, Faldella, G., additional, Spinelli, M., additional, Bottau, P., additional, Fanos, V., additional, Puddu, M., additional, Rinaldi, M., additional, Barberi, I., additional, Pagano, G., additional, Scarcella, A., additional, Umbaldo, A., additional, Corsello, G., additional, Gabriele, B., additional, Barboni, G., additional, Molinari, L., additional, Boldrini, A., additional, Vuerich, M., additional, Ngalikpima, C.J., additional, Gargano, G., additional, Braibanti, S., additional, Romagnoli, C., additional, Aurilia, C., additional, Paolillo, P., additional, Picone, S., additional, De Curtis, M., additional, Natale, F., additional, Romeo, N., additional, Piano, F., additional, Nosari, N., additional, Sarnelli, P., additional, Parmigiani, S., additional, Corona, M.F., additional, Fabris, C., additional, Gaudino, M., additional, Bonomi, A., additional, Ladetto, L., additional, Memo, L., additional, Nicolini, G., additional, Macagno, F., additional, Rodaro, E., additional, Dall'Agnola, A., additional, Zardini, F., additional, Manzoni, P., additional, and Lanari, M., additional

Published
2012
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40. A33 Is the presence of Candida Mannan antigen in bronchoalveolar lavage fluid of premature neonates correlated with the levels of α-defensins and S100 proteins?

Author

Aurilia, C., primary, Lio, A., additional, Tirone, C., additional, Tana, M., additional, Iavarone, F., additional, Fanali, C., additional, Piras, A., additional, Ricci, C., additional, Perelli, S., additional, Castagnola, M., additional, Romagnoli, C., additional, and Vento, G., additional

Published
2012
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43. Efficacy of exogenous surfactant during conventional and high-frequency oscillatory ventilation in preterm infants with RDS

Author

Giovanni Vento, Tana, M., Tirone, C., Aurilia, C., Lio, A., Perelli, S., Ricci, C., and Romagnoli, C.

Subjects
Respiratory Distress Syndrome, Respiratory Distress Syndrome, Newborn, Pulmonary Gas Exchange, Infant, Newborn, Infant, High-Frequency Ventilation, Pulmonary Surfactants, Newborn, Intensive Care Units, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Neonatal, Intensive Care Units, Neonatal, Humans, Lung Volume Measurements, Premature, Infant, Premature
Abstract

The immediate effects of exogenous surfactant on lung volume and hemodynamics in preterm infants have been poorly studied.Lung volume, SpO2, perfusion index, regional SO2, transcutaneous partial pressure of CO2 were simultaneously monitored and recorded ten minutes after surfactant tracheal instillation in elective HFOV ventilated preterm infants with RDS.Despite a reduction in gas exchange during the first 5 minutes post surfactant instillation, most likely dependent on airway obstruction, lung volume increases rapidly in HFOV preterm infants with RDS. After 5 minutes from administration of surfactant, lung volume, gas exchange and PI reach stable values and CDP can be safely reduced.

44. Target fraction of inspired oxygen during open lung strategy in neonatal high frequency oscillatory ventilation: A retrospective study

Author

Milena Tana, Zecca, E., Tirone, C., Aurilia, C., Cota, F., Lio, A., Tesfagabir, M. G., Romagnoli, C., and Vento, G.

Subjects
Male, Oxygen, Respiratory Distress Syndrome, Newborn, Infant, Newborn, Humans, Female, Intermittent Positive-Pressure Ventilation, Retrospective Studies
Abstract

There is no agreement to define the target FiO2 to adopt in the lung recruitment phase during HFOV in preterm infants. We report our experience of an optimal lung volume strategy (OLVS), defined as FiO2≤0.25 during the recruitment phase, in a cohort of neonates with gestational age (GA) ≤27 weeks treated with elective HFOV for respiratory distress syndrome (RDS) between July 2006 and September 2008.FiO2 used during the recruitment phase was different according to physician' evaluation. 51 newborns were then divided into two groups: patients reaching FiO2≤0.25 (OLVS Group, N.=28), and patients reaching FiO20.25 (No-OLVS Group, N.=23).Prior to surfactant administration OLVS Group, respect to No-OLVS Group, received a significantly higher continuous distending pressure (CDP): 12.8±1.1 cmH2O vs 11.2±1.3 cmH2O (P0.0001) and a significantly lower FiO2: 0.25±0.01 vs 0.35±0.06 (P0.0001). A multivariate modeling approach confirmed that OLVS was significantly associated to the need for less surfactant doses (OR 0.19[95% CI 0.05-0.84]), a decreased risk of ductus arteriosus surgically ligated (OR 0.13[95% CI 0.02-0.86]) and to a lower number of ventilation hours before extubation: -152 (95% CI -284- -20).OLVS to fully recruit the lungs achieving FiO2≤0.25 during elective HFOV is associated with better short-term pulmonary outcomes respect to a strategy where the patients received a FiO20.25 during the recruitment phase. Utilizing HFOV in this way provides a more effective means to recruit and protect acutely injured lungs.

45. Proteomics and neonatal infection

Author

Giovanni Vento, Tirone, C., Aurilia, C., Tana, M., Piras, A., Lio, A., Tesfagabir, G., Castagnola, M., Fanali, C., and Romagnoli, C.

Subjects
Proteomics, Spectrometry, Mass, Electrospray Ionization, alpha-Defensins, beta-Defensins, Proteomics and neonatal infection, Diseases, Gestational Age, Infant, Premature, Diseases, Infections, Cohort Studies, Innate, Humans, Premature, Chromatography, High Pressure Liquid, Chromatography, Molecular Structure, Spectrometry, Electrospray Ionization, Immunity, Infant, Newborn, Infant, Mass, Newborn, Amniotic Fluid, Immunity, Innate, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, High Pressure Liquid, Infection, Bronchoalveolar Lavage Fluid, Antimicrobial Cationic Peptides
Abstract

Antimicrobial peptides plays an important role in the host innate defence network, even in humans. Recent studies demonstrated the capacity of human airways epithelial cells to synthesize antimicrobial peptides, and their multifunctional role in the primary immunity. The presence of ct-defensins in bronchoalveolar lavage fluid (BALF) was investigated in a cohort of preterm newborns with gestational age (GA)or =30 weeks. BALF samples were analysed by High Performance Liquid Chromatography Electrospray Ionization Mass Spectrometer. Our data show that preterm newborns, also at the lower GA, are able to produce defenses, underlining that their innate defence system is already active before the at-term delivery date.

47. Lung recruitment strategies and surfactant in neonatal intensive care unit

Author

Vento, G., Milena Tana, Tirone, C., Aurilia, C., Lio, A., Ricci, C., Gambacorta, A., and Romagnoli, C.

Subjects
Respiratory Distress Syndrome, Newborn, Resuscitation, Infant, Newborn, Pulmonary Surfactants, Respiration, Artificial, Surface-Active Agents, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Pregnancy, Intensive Care Units, Neonatal, Surfactant, Intubation, Intratracheal, Humans, Female, Infant, Premature
Abstract

Several studies in the lamb model have shown that hyperinflation of the lungs early in life may cause a blunted response to surfactant with signs of lung injury and any attempt to recruit lung volume in the surfactant deficient preterm infant by large lung inflations at birth should be potentially dangerous. As regards the situation when surfactant is given later, as rescue treatment for established RDS, the evidence for a clinically beneficial effect of a recruitment maneuver is yet insufficient and, hopefully, future studies will gather more data on this aspect.

48. Socio-economic costs of migraine.

Author

Cerbo R, Pesare M, Aurilia C, Rondelli V, and Barbanti P

Abstract

Migraine is one of the most common neurological diseases afflicting 12% of general population but is poorly recognized and largely untreated. Migraine is a disabling disease with very high social costs as it affects young individuals during their productive age. Quality of life in migraineurs is impaired. Furthermore, the economic burden of migraine, usually evaluated in terms of direct and indirect costs, is relevant and could be reduced by an early diagnosis and an appropriate treatment. [ABSTRACT FROM AUTHOR]

Published
2001

49. Validation of a self-reported instrument to assess work-related difficulties in patients with migraine: the HEADWORK questionnaire

Author

Venusia Covelli, Carlo Lovati, Luca Giani, Marco Bartolini, Antonio Russo, Laura Rapisarda, Giovanna Viticchi, Alberto Raggi, Francesco Bono, Licia Grazzi, Domenico D'Amico, Sabina Cevoli, Giulia Pierangeli, Gioacchino Tedeschi, Fabio Frediani, Cinzia Aurilia, Piero Barbanti, Paola Di Fiore, Chiara Scaratti, Matilde Leonardi, Erika Guastafierro, Raggi, A., Covelli, V., Guastafierro, E., Leonardi, M., Scaratti, C., Grazzi, L., Bartolini, M., Viticchi, G., Cevoli, S., Pierangeli, G., Tedeschi, G., Russo, A., Barbanti, P., Aurilia, C., Lovati, C., Giani, L., Frediani, F., DI Fiore, P., Bono, F., Rapisarda, L., D'Amico, D., and Raggi A, Covelli V, Guastafierro E, Leonardi M, Scaratti C, Grazzi L, Bartolini M, Viticchi G, Cevoli S, Pierangeli G, Tedeschi G, Russo A, Barbanti P, Aurilia C, Lovati C, Giani L, Frediani F, Di Fiore P, Bono F, Rapisarda L, D'Amico D.

Subjects
Employment, Adult, Male, Work, Disability evaluation, Migraine Disorders, lcsh:Medicine, Work Capacity Evaluation, Work related, 03 medical and health sciences, Occupational Stress, 0302 clinical medicine, Chronic Migraine, Migraine Disorder, Quality of life, Surveys and Questionnaires, medicine, Surveys and Questionnaire, Humans, Disabled Persons, 030212 general & internal medicine, Episodic migraine, Set (psychology), Work Performance, Chronic migraine, business.industry, lcsh:R, Validation study, Occupational Stre, Construct validity, General Medicine, Middle Aged, medicine.disease, Focus group, Confirmatory factor analysis, Anesthesiology and Pain Medicine, Migraine, Italy, Quality of Life, Disabled Person, Female, Neurology (clinical), Self Report, business, 030217 neurology & neurosurgery, Medication overuse headache, Human, Clinical psychology
Abstract

Background The degree to which work-related difficulties are recognized in headache research is poor and often carried out with inadequate information such as “reduced ability to work as usual”, which do not capture at all the variety of difficulties and the factors that impact over them. The aim of this paper is to present the validation of the HEADWORK questionnaire, which addresses the amount and severity of difficulties in work-related tasks and the factors that impact over them. Methods We developed a set of items based on a previous literature review and patients’ focus groups and tested it on a wide set of patients with episodic and chronic migraine attending eight different Italian headache centers. HEADWORK factor structure was assessed with exploratory and confirmatory factor analysis; internal consistency and construct validity were addressed as well. Results The validation sample (N = 373) was mostly composed of patients with episodic migraine without aura (64.3%) and of females (81%). Factor analysis retrieved two different scales: “Work-related difficulties”, composed of eleven items which explain 67.1% of the total variance, and “Factors contributing to work difficulties”, composed of six items which explain 52.1% of the total variance. Both HEADWORK subscales have good measurement properties, with higher scores being associated to higher disability, lower quality of life, lower productivity, higher headache frequency and pain intensity. Conclusions HEADWORK is a 17-item, two-scale questionnaire addressing the impact of migraine on work-related difficulties in terms of difficulties in general or specific skills, and the factors contributing to these difficulties, defined as negative impact on work tasks. It can be used to address disability weights for the purpose of calculating the burden of migraine, and to assess the balance between therapeutic and side effects of medication on productivity.

Published
2018

50. Erenumab in the prevention of high‐frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real‐life study

Author

Francesco Bono, Piero Barbanti, Fabrizio Vernieri, Gabriella Egeo, Bruno Mercuri, Massimo Filippi, Cinzia Aurilia, Antonio Salerno, Licia Grazzi, Sabina Cevoli, Fabio Frediani, Antonio Carnevale, Bruno Colombo, Luisa Fofi, Claudia Altamura, Barbanti, P., Aurilia, C., Egeo, G., Fofi, L., Cevoli, S., Colombo, B., Filippi, M., Frediani, F., Bono, F., Grazzi, L., Salerno, A., Mercuri, B., Carnevale, A., Altamura, C., and Vernieri, F.

Subjects
Adult, Male, medicine.medical_specialty, Visual analogue scale, Migraine Disorders, Population, Effectiveness, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, 0302 clinical medicine, Chronic Migraine, Cost of Illness, Calcitonin Gene-Related Peptide Receptor Antagonists, Interquartile range, Internal medicine, Outcome Assessment, Health Care, medicine, Clinical endpoint, Humans, Prospective Studies, 030212 general & internal medicine, education, Migraine, Pain Measurement, education.field_of_study, business.industry, Real-life, Middle Aged, medicine.disease, Treatment, Italy, Neurology, Tolerability, Calcitonin gene-related peptide, Cohort, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Erenumab
Abstract

Objective: To assess the effectiveness, safety, and tolerability of erenumab in a real-life migraine population, while trying to identify responsiveness predictors. Background: Erenumab is a fully human Ig-2 monoclonal antibody blocking the calcitonin gene-related peptide receptor, indicated for migraine prophylaxis. Phase II and III trials demonstrated that erenumab is effective, safe, and well tolerated in the prevention of episodic and chronic migraine (CM), showing an early onset of action. Methods: This is a multicenter, prospective, cohort, and real-life study. We considered for enrolment all consecutive patients aged 18–65 affected by high-frequency episodic migraine (HFEM) or CM, with or without medication overuse, visited at nine Italian Headache Centers from December 20, 2018 to September 30, 2019. Each patient was treated with erenumab 70mg, administered subcutaneously every 4weeks. Treatment duration was planned to last from 6 to 12months, depending on the patient's response. The primary endpoint was the change in monthly migraine days (MMDs) at weeks 9–12 compared to baseline. Secondary endpoints included changes in monthly analgesics intake, ≥50%, ≥75%, and 100% responder rates and any variation in the Visual Analog Scale (VAS) and Headache Impact Test scores (HIT). Results: In total, 372 migraine patients were treated with at least one dose of erenumab 70mg. At weeks 9–12, erenumab decreased MMDs by 4.5±4.1days (mean±SD) in patients with HFEM and by 9.3±9.1 (mean±SD) days in those with CM compared to baseline. At weeks 9–12 VAS score was reduced by 1.9±1.9 (mean±SD), HIT score by 10.7±8.8 (mean±SD), and median monthly analgesics intake passed from 12.0 (interquartile range [IQR] 10.0–14.0) to 5.0 (IQR 3.0–7.0) in HFEM. In CM patients, VAS was reduced by 1.7±2.0 (mean±SD), HIT by 9.7±10.4 (mean±SD), and median monthly analgesics intake passed from 20.0 (IQR 15.0–30.0) to 8.0 (IQR 5.0–15.0). At week 12, ≥50% responders were 60/101 (59.4%) for HFEM and 146/263 (55.5%) for CM, ≥75% responders were 17/101 (16.8%) and 59/263 (22.4%) and 100% responders 1/101 (1.0%) and 3/263 (1.1%), respectively. Erenumab responsiveness in HFEM was positively associated with unilateral pain localization (OR: 3.03, 95% CI: 1.24–7.40; p=0.015), whereas in CM responsiveness was positively associated with and baseline migraine frequency (OR: 1.06, 95% CI:1.02–1.11; p=0.031), dopaminergic symptoms (OR: 2.01, 95% CI: 1.14–3.52; p=0.015), and negatively associated with psychiatric comorbidities (OR: 0.43, 95% CI: 0.20–0.93; p=0.003). Conclusions: Erenumab 70mg is effective, safe, and well tolerated in real life. Easily obtainable clinical features might be of help in predicting patient's responsiveness.

Published
2020

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