3 results on '"Tirantello M"'
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2. Comparison of "IN-REC-SUR-E" and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial).
- Author
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Vento G, Paladini A, Aurilia C, Ozdemir SA, Carnielli VP, Cools F, Costa S, Cota F, Dani C, Davis PG, Fattore S, Fè C, Finer N, Fusco FP, Gizzi C, Herting E, Jian M, Lio A, Lista G, Mosca F, Nobile S, Perri A, Picone S, Pillow JJ, Polglase G, Pasciuto T, Pastorino R, Tana M, Tingay D, Tirone C, van Kaam AH, Ventura ML, Aceti A, Agosti M, Alighieri G, Ancora G, Angileri V, Ausanio G, Aversa S, Balestri E, Baraldi E, Barbini MC, 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 MF, Capasso L, Capozza M, Capretti MG, 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 LT, 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 VA, Fatuzzo V, Favini F, Ferrarello MP, Ferrari S, Nastro FF, Forcellini CA, Fracchiolla A, Gabriele A, Galdo F, Gallini F, Gangemi A, Gargano G, Gazzolo D, Gentile MP, 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 IV, 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 MG, Pasta E, Patti L, Paviotti G, Perniola R, Perotti G, Perrone S, Petrillo F, Piazza MS, Piccirillo A, Pierro M, Piga E, Pingitore GA, 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 FM, 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 SS, 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 PE, Viola S, Viola V, Vitaliti G, Vitaliti M, Wanker P, Yang Y, Zanetta S, and Zannin E
- Subjects
- Female, Humans, Infant, Newborn, Airway Extubation adverse effects, Bronchopulmonary Dysplasia therapy, Continuous Positive Airway Pressure, Gestational Age, Intubation, Intratracheal, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, Infant, Premature, Pulmonary Surfactants administration & dosage, Respiratory Distress Syndrome, Newborn therapy, Respiratory Distress Syndrome, Newborn mortality
- 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., (© 2024. The Author(s).)- Published
- 2024
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3. Off-Label Use of Drugs and Adverse Drug Reactions in Pediatric Units: A Prospective, Multicenter Study.
- Author
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Pratico AD, Longo L, Mansueto S, Gozzo L, Barberi I, Tiralongo V, Salvo V, Falsaperla R, Vitaliti G, La Rosa M, Leonardi S, Rotondo A, Avola N, Sgarlata D, Damiano A, Tirantello M, Anzelmo G, Cipolla D, Rizzo A, Russo A, Ruggieri M, Salomone S, and Drago F
- Subjects
- Adolescent, Child, Child, Preschool, Drug Labeling, Female, Humans, Infant, Infant, Newborn, Intensive Care Units, Neonatal statistics & numerical data, Italy, Male, Prospective Studies, Drug-Related Side Effects and Adverse Reactions epidemiology, Off-Label Use statistics & numerical data, Pharmacovigilance, Practice Patterns, Physicians' statistics & numerical data
- Abstract
Background: Given the growing use of off-label in pediatric practice, there is a growing interest on pharmacovigilance programs monitoring the occurrence of adverse drug reactions related to off-label drug prescription in childhood., Patients and Methods: The results of a one-year program of pharmacovigilance issued in the Sicilian Region, Italy, are herein presented. The study involved 6 pediatric and neonatal centres and prospectively reviewed the prescriptions of 5,060 patients, who were stratified for age (newborn, infant, children, adolescents)., Results: A total of 14,916 prescriptions were issued for 5,060 patients. Among them, 454 patients [8.97%] received at least one off-label drug. Among the off-label treated patients, 255 [56.2%] were newborns. Anti-infective drugs were the most frequent off-label used drugs, followed by drugs for alimentary tract and metabolism and drugs for blood or blood forming organs. Ninety adverse drug reactions were recorded [1.78% of the total patients]. They occurred after an off-label prescription in 33 out of 90 [36.7%], while those occurring after an on-label prescription were 57 [63.3%]. Patients treated with an off-label drug had a significantly higher risk of adverse drug reactions [7.3% vs. 1.2%; p <0.01]., Conclusion: The present study indicates that children admitted to neonatal intensive care units are likely to receive an off-label medication; children who receive an off-label medication are usually more likely to be treated with more medication than the others; adverse drug reactions occur in patients admitted in neonatal intensive care and pediatrics are units are more frequently with off-label than with on-label drugs., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)
- Published
- 2018
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