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

  1. Vento, Giovanni
  2. Paladini, Angela ORCID logo
  3. Aurilia, C.
  4. Ozdemir, S. Alkan
  5. Carnielli, V. P.
  6. Cools, F.
  7. Costa, S.
  8. Cota, F.
  9. Dani, C.
  10. Davis, P. G.
  11. Fattore, S.
  12. Fè, C.
  13. Finer, N.
  14. Fusco, F. P.
  15. Gizzi, C.
  16. Herting, E.
  17. Jian, M.
  18. Lio, A.
  19. Lista, G.
  20. Mosca, F.
  21. Nobile, S.
  22. Perri, A.
  23. Picone, S.
  24. Pillow, J. J.
  25. Polglase, G.
  26. Pasciuto, T.
  27. Pastorino, R.
  28. Tana, M.
  29. Tingay, D.
  30. Tirone, C.
  31. van Kaam, A. H.
  32. Ventura, M. L.
  33. Aceti, A.
  34. Agosti, M.
  35. Alighieri, G.
  36. Ancora, G.
  37. Angileri, V.
  38. Ausanio, G.
  39. Aversa, S.
  40. Balestri, E.
  41. Baraldi, E.
  42. Barbini, M. C.
  43. Barone, C.
  44. Beghini, R.
  45. Bellan, C.
  46. Berardi, A.
  47. Bernardo, I.
  48. Betta, P.
  49. Binotti, M.
  50. Bizzarri, B.
  51. Borgarello, G.
  52. Borgione, S.
  53. Borrelli, A.
  54. Bottino, R.
  55. Bracaglia, G.
  56. Bresesti, I.
  57. Burattini, I.
  58. Cacace, C.
  59. Calzolari, F.
  60. Campagnoli, M. F.
  61. Capasso, L.
  62. Capozza, M.
  63. Capretti, M. G.
  64. Caravetta, J.
  65. Carbonara, C.
  66. Cardilli, V.
  67. Carta, M.
  68. Castoldi, F.
  69. Castronovo, A.
  70. Cavalleri, E.
  71. Cavigioli, F.
  72. Cecchi, S.
  73. Chierici, V.
  74. Cimino, C.
  75. Cocca, F.
  76. Cocca, C.
  77. Cogo, P.
  78. Coma, M.
  79. Comito, V.
  80. Condò, V.
  81. Consigli, C.
  82. Conti, R.
  83. Corradi, M.
  84. Corsello, G.
  85. Corvaglia, L. T.
  86. Costa, A.
  87. Coscia, A.
  88. Cresi, F.
  89. Crispino, F.
  90. D’Amico, P.
  91. De Cosmo, L.
  92. De Maio, C.
  93. Del Campo, G.
  94. Di Credico, S.
  95. Di Fabio, S.
  96. Di Nicola, P.
  97. Di Paolo, A.
  98. Di Valerio, S.
  99. Distilo, A.
  100. Duca, V.
  101. Falcone, A.
  102. Falsaperla, R.
  103. Fasolato, V. A.
  104. Fatuzzo, V.
  105. Favini, F.
  106. Ferrarello, M. P.
  107. Ferrari, S.
  108. Nastro, F. Fiori
  109. Forcellini, C. A.
  110. Fracchiolla, A.
  111. Gabriele, A.
  112. Galdo, F.
  113. Gallini, F.
  114. Gangemi, A.
  115. Gargano, G.
  116. Gazzolo, D.
  117. Gentile, M. P.
  118. Ghirardello, S.
  119. Giardina, F.
  120. Giordano, L.
  121. Gitto, E.
  122. Giuffrè, M.
  123. Grappone, L.
  124. Grasso, F.
  125. Greco, I.
  126. Grison, A.
  127. Guglielmino, R.
  128. Guidotti, I.
  129. Guzzo, I.
  130. La Forgia, N.
  131. La Placa, S.
  132. La Torre, G.
  133. Lago, P.
  134. Lanciotti, L.
  135. Lavizzari, A.
  136. Leo, F.
  137. Leonardi, V.
  138. Lestingi, D.
  139. Li, J.
  140. Liberatore, P.
  141. Lodin, D.
  142. Lubrano, R.
  143. Lucente, M.
  144. Luciani, S.
  145. Luvarà, D.
  146. Maffei, G.
  147. Maggio, A.
  148. Maggio, L.
  149. Maiolo, K.
  150. Malaigia, L.
  151. Mangili, G.
  152. Manna, A.
  153. Maranella, E.
  154. Marciano, A.
  155. Marcozzi, P.
  156. Marletta, M.
  157. Marseglia, L.
  158. Martinelli, D.
  159. Martinelli, S.
  160. Massari, S.
  161. Massenzi, L.
  162. Matina, F.
  163. Mattia, L.
  164. Mescoli, G.
  165. Migliore, I. V.
  166. Minghetti, D.
  167. Mondello, I.
  168. Montano, S.
  169. Morandi, G.
  170. Mores, N.
  171. Morreale, S.
  172. Morselli, I.
  173. Motta, M.
  174. Napolitano, M.
  175. Nardo, D.
  176. Nicolardi, A.
  177. Nider, S.
  178. Nigro, G.
  179. Nuccio, M.
  180. Orfeo, L.
  181. Ottaviano, C.
  182. Paganin, P.
  183. Palamides, S.
  184. Palatta, S.
  185. Paolillo, P.
  186. Pappalardo, M. G.
  187. Pasta, E.
  188. Patti, L.
  189. Paviotti, G.
  190. Perniola, R.
  191. Perotti, G.
  192. Perrone, S.
  193. Petrillo, F.
  194. Piazza, M. S.
  195. Piccirillo, A.
  196. Pierro, M.
  197. Piga, E.
  198. Pingitore, G. A.
  199. Pisu, S.
  200. Pittini, C.
  201. Pontiggia, F.
  202. Pontrelli, G.
  203. Primavera, A.
  204. Proto, A.
  205. Quartulli, L.
  206. Raimondi, F.
  207. Ramenghi, L.
  208. Rapsomaniki, M.
  209. Ricotti, A.
  210. Rigotti, C.
  211. Rinaldi, M.
  212. Risso, F. M.
  213. Roma, E.
  214. Romanini, E.
  215. Romano, V.
  216. Rosati, E.
  217. Rosella, V.
  218. Rulli, I.
  219. Salvo, V.
  220. Sanfilippo, C.
  221. Sannia, A.
  222. Saporito, A.
  223. Sauna, A.
  224. Scapillati, E.
  225. Schettini, F.
  226. Scorrano, A.
  227. Mantelli, S. Semeria
  228. Sepporta, V.
  229. Sindico, P.
  230. Solinas, A.
  231. Sorrentino, E.
  232. Spaggiari, E.
  233. Staffler, A.
  234. Stella, M.
  235. Termini, D.
  236. Terrin, G.
  237. Testa, A.
  238. Tina, G.
  239. Tirantello, M.
  240. Tomasini, B.
  241. Tormena, F.
  242. Travan, L.
  243. Trevisanuto, D.
  244. Tuling, G.
  245. Tulino, V.
  246. Valenzano, L.
  247. Vedovato, S.
  248. Vendramin, S.
  249. Villani, P. E.
  250. Viola, S.
  251. Viola, V.
  252. Vitaliti, G.
  253. Vitaliti, M.
  254. Wanker, P.
  255. Yang, Y.
  256. Zanetta, S.
  257. Zannin, E.

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13063_2024_Article_8240.pdf 1,51MB
WeightNameValue
1000 Titel
  • Comparison of “IN-REC-SUR-E” and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial)
1000 Autor/in
  1. Vento, Giovanni |
  2. Paladini, Angela |
  3. Aurilia, C. |
  4. Ozdemir, S. Alkan |
  5. Carnielli, V. P. |
  6. Cools, F. |
  7. Costa, S. |
  8. Cota, F. |
  9. Dani, C. |
  10. Davis, P. G. |
  11. Fattore, S. |
  12. Fè, C. |
  13. Finer, N. |
  14. Fusco, F. P. |
  15. Gizzi, C. |
  16. Herting, E. |
  17. Jian, M. |
  18. Lio, A. |
  19. Lista, G. |
  20. Mosca, F. |
  21. Nobile, S. |
  22. Perri, A. |
  23. Picone, S. |
  24. Pillow, J. J. |
  25. Polglase, G. |
  26. Pasciuto, T. |
  27. Pastorino, R. |
  28. Tana, M. |
  29. Tingay, D. |
  30. Tirone, C. |
  31. van Kaam, A. H. |
  32. Ventura, M. L. |
  33. Aceti, A. |
  34. Agosti, M. |
  35. Alighieri, G. |
  36. Ancora, G. |
  37. Angileri, V. |
  38. Ausanio, G. |
  39. Aversa, S. |
  40. Balestri, E. |
  41. Baraldi, E. |
  42. Barbini, M. C. |
  43. Barone, C. |
  44. Beghini, R. |
  45. Bellan, C. |
  46. Berardi, A. |
  47. Bernardo, I. |
  48. Betta, P. |
  49. Binotti, M. |
  50. Bizzarri, B. |
  51. Borgarello, G. |
  52. Borgione, S. |
  53. Borrelli, A. |
  54. Bottino, R. |
  55. Bracaglia, G. |
  56. Bresesti, I. |
  57. Burattini, I. |
  58. Cacace, C. |
  59. Calzolari, F. |
  60. Campagnoli, M. F. |
  61. Capasso, L. |
  62. Capozza, M. |
  63. Capretti, M. G. |
  64. Caravetta, J. |
  65. Carbonara, C. |
  66. Cardilli, V. |
  67. Carta, M. |
  68. Castoldi, F. |
  69. Castronovo, A. |
  70. Cavalleri, E. |
  71. Cavigioli, F. |
  72. Cecchi, S. |
  73. Chierici, V. |
  74. Cimino, C. |
  75. Cocca, F. |
  76. Cocca, C. |
  77. Cogo, P. |
  78. Coma, M. |
  79. Comito, V. |
  80. Condò, V. |
  81. Consigli, C. |
  82. Conti, R. |
  83. Corradi, M. |
  84. Corsello, G. |
  85. Corvaglia, L. T. |
  86. Costa, A. |
  87. Coscia, A. |
  88. Cresi, F. |
  89. Crispino, F. |
  90. D’Amico, P. |
  91. De Cosmo, L. |
  92. De Maio, C. |
  93. Del Campo, G. |
  94. Di Credico, S. |
  95. Di Fabio, S. |
  96. Di Nicola, P. |
  97. Di Paolo, A. |
  98. Di Valerio, S. |
  99. Distilo, A. |
  100. Duca, V. |
  101. Falcone, A. |
  102. Falsaperla, R. |
  103. Fasolato, V. A. |
  104. Fatuzzo, V. |
  105. Favini, F. |
  106. Ferrarello, M. P. |
  107. Ferrari, S. |
  108. Nastro, F. Fiori |
  109. Forcellini, C. A. |
  110. Fracchiolla, A. |
  111. Gabriele, A. |
  112. Galdo, F. |
  113. Gallini, F. |
  114. Gangemi, A. |
  115. Gargano, G. |
  116. Gazzolo, D. |
  117. Gentile, M. P. |
  118. Ghirardello, S. |
  119. Giardina, F. |
  120. Giordano, L. |
  121. Gitto, E. |
  122. Giuffrè, M. |
  123. Grappone, L. |
  124. Grasso, F. |
  125. Greco, I. |
  126. Grison, A. |
  127. Guglielmino, R. |
  128. Guidotti, I. |
  129. Guzzo, I. |
  130. La Forgia, N. |
  131. La Placa, S. |
  132. La Torre, G. |
  133. Lago, P. |
  134. Lanciotti, L. |
  135. Lavizzari, A. |
  136. Leo, F. |
  137. Leonardi, V. |
  138. Lestingi, D. |
  139. Li, J. |
  140. Liberatore, P. |
  141. Lodin, D. |
  142. Lubrano, R. |
  143. Lucente, M. |
  144. Luciani, S. |
  145. Luvarà, D. |
  146. Maffei, G. |
  147. Maggio, A. |
  148. Maggio, L. |
  149. Maiolo, K. |
  150. Malaigia, L. |
  151. Mangili, G. |
  152. Manna, A. |
  153. Maranella, E. |
  154. Marciano, A. |
  155. Marcozzi, P. |
  156. Marletta, M. |
  157. Marseglia, L. |
  158. Martinelli, D. |
  159. Martinelli, S. |
  160. Massari, S. |
  161. Massenzi, L. |
  162. Matina, F. |
  163. Mattia, L. |
  164. Mescoli, G. |
  165. Migliore, I. V. |
  166. Minghetti, D. |
  167. Mondello, I. |
  168. Montano, S. |
  169. Morandi, G. |
  170. Mores, N. |
  171. Morreale, S. |
  172. Morselli, I. |
  173. Motta, M. |
  174. Napolitano, M. |
  175. Nardo, D. |
  176. Nicolardi, A. |
  177. Nider, S. |
  178. Nigro, G. |
  179. Nuccio, M. |
  180. Orfeo, L. |
  181. Ottaviano, C. |
  182. Paganin, P. |
  183. Palamides, S. |
  184. Palatta, S. |
  185. Paolillo, P. |
  186. Pappalardo, M. G. |
  187. Pasta, E. |
  188. Patti, L. |
  189. Paviotti, G. |
  190. Perniola, R. |
  191. Perotti, G. |
  192. Perrone, S. |
  193. Petrillo, F. |
  194. Piazza, M. S. |
  195. Piccirillo, A. |
  196. Pierro, M. |
  197. Piga, E. |
  198. Pingitore, G. A. |
  199. Pisu, S. |
  200. Pittini, C. |
  201. Pontiggia, F. |
  202. Pontrelli, G. |
  203. Primavera, A. |
  204. Proto, A. |
  205. Quartulli, L. |
  206. Raimondi, F. |
  207. Ramenghi, L. |
  208. Rapsomaniki, M. |
  209. Ricotti, A. |
  210. Rigotti, C. |
  211. Rinaldi, M. |
  212. Risso, F. M. |
  213. Roma, E. |
  214. Romanini, E. |
  215. Romano, V. |
  216. Rosati, E. |
  217. Rosella, V. |
  218. Rulli, I. |
  219. Salvo, V. |
  220. Sanfilippo, C. |
  221. Sannia, A. |
  222. Saporito, A. |
  223. Sauna, A. |
  224. Scapillati, E. |
  225. Schettini, F. |
  226. Scorrano, A. |
  227. Mantelli, S. Semeria |
  228. Sepporta, V. |
  229. Sindico, P. |
  230. Solinas, A. |
  231. Sorrentino, E. |
  232. Spaggiari, E. |
  233. Staffler, A. |
  234. Stella, M. |
  235. Termini, D. |
  236. Terrin, G. |
  237. Testa, A. |
  238. Tina, G. |
  239. Tirantello, M. |
  240. Tomasini, B. |
  241. Tormena, F. |
  242. Travan, L. |
  243. Trevisanuto, D. |
  244. Tuling, G. |
  245. Tulino, V. |
  246. Valenzano, L. |
  247. Vedovato, S. |
  248. Vendramin, S. |
  249. Villani, P. E. |
  250. Viola, S. |
  251. Viola, V. |
  252. Vitaliti, G. |
  253. Vitaliti, M. |
  254. Wanker, P. |
  255. Yang, Y. |
  256. Zanetta, S. |
  257. Zannin, E. |
1000 Verlag
  • BioMed Central
1000 Erscheinungsjahr 2024
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2024-07-02
1000 Erschienen in
1000 Quellenangabe
  • 25(1):433
1000 Copyrightjahr
  • 2024
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s13063-024-08240-4 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11218154/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>In this study, 382 infants born at 24<jats:sup>+0</jats:sup>–27<jats:sup>+6</jats:sup> 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<jats:sup>+0</jats:sup> to 25<jats:sup>+6</jats:sup> weeks or 26<jats:sup>+0</jats:sup> to 27<jats:sup>+6</jats:sup> weeks).</jats:p> <jats:p>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).</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24<jats:sup>+0</jats:sup>–27<jats:sup>+6</jats:sup> 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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.</jats:p> </jats:sec>
1000 Sacherschließung
lokal Infant, Newborn [MeSH]
lokal Female [MeSH]
lokal Infant, Premature [MeSH]
lokal Preterm infants
lokal INRECSURE
lokal Airway Extubation/adverse effects [MeSH]
lokal HFOV
lokal Study Protocol
lokal Humans [MeSH]
lokal Pulmonary Surfactants/administration
lokal Treatment Outcome [MeSH]
lokal Bronchopulmonary Dysplasia/therapy [MeSH]
lokal Respiratory Distress Syndrome, Newborn/therapy [MeSH]
lokal Multicenter Studies as Topic [MeSH]
lokal Surfactant
lokal Time Factors [MeSH]
lokal Randomized Controlled Trials as Topic [MeSH]
lokal Intubation, Intratracheal [MeSH]
lokal Respiratory Distress Syndrome, Newborn/mortality [MeSH]
lokal Lung recruitment
lokal LISA
lokal Continuous Positive Airway Pressure [MeSH]
lokal Gestational Age [MeSH]
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. 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1000 Hinweis
  • DeepGreen-ID: cf74f78ae4ff45a0b76194f9b11af69f ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search)
1000 Label
1000 Förderer
  1. Chiesi Foundation |
  2. Vygon Italia s.r.l. |
1000 Fördernummer
  1. -
  2. -
1000 Förderprogramm
  1. -
  2. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Chiesi Foundation |
    1000 Förderprogramm -
    1000 Fördernummer -
  2. 1000 joinedFunding-child
    1000 Förderer Vygon Italia s.r.l. |
    1000 Förderprogramm -
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6522897.rdf
1000 Erstellt am 2025-07-06T17:48:42.125+0200
1000 Erstellt von 322
1000 beschreibt frl:6522897
1000 Zuletzt bearbeitet 2025-07-29T17:45:12.285+0200
1000 Objekt bearb. Tue Jul 29 17:45:12 CEST 2025
1000 Vgl. frl:6522897
1000 Oai Id
  1. oai:frl.publisso.de:frl:6522897 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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