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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>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In this study, 382 infants born at 24<jats:sup>+0<\/jats:sup>\u201327<jats:sup>+6<\/jats:sup>\u00a0weeks\u2019 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\u00a0h 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\u00a0weeks\u2019 postmenstrual age. The secondary outcomes are BPD at 36\u00a0weeks\u2019 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\u00a0months 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>\u00a0weeks or 26<jats:sup>+0<\/jats:sup> to 27<jats:sup>+6<\/jats:sup>\u00a0weeks).<\/jats:p>\n                <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>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <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>\u201327<jats:sup>+6<\/jats:sup>\u00a0weeks\u2019 gestation affected by RDS and failing nCPAP or NIPPV during the first 24\u00a0h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36\u00a0weeks\u2019 postmenstrual age of life.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08240-4","type":"journal-article","created":{"date-parts":[[2024,7,2]],"date-time":"2024-07-02T07:02:51Z","timestamp":1719903771000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Comparison of \u201cIN-REC-SUR-E\u201d and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial)"],"prefix":"10.1186","volume":"25","author":[{"given":"Giovanni","family":"Vento","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6344-5769","authenticated-orcid":false,"given":"Angela","family":"Paladini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Aurilia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. 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Gemelli IRCCS, Universit\u00e0 Cattolica del Sacro Cuore, Rome, Italy (NCT05711966 -last release 16 Feb 2023). The ethical bodies of the participating centers approved the study.Informed written consent will be signed by both parents, and sufficient time will be provided for consent. If parents do not speak the local language, consent will only be obtained if an adult and independent interpreter is available. The parents will be informed that the study does not entail a blood sample or other more invasive interventions than maneuvers performed regularly in the neonatal intensive care unit (NICU). The informed consent will be obtained by the principal investigator of each participating center and his collaborators in charge.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate\u00a0{24}"}},{"value":"Informed consent has been obtained for the collection of patient data. However, no personal data is used in this protocol.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication\u00a0{32}"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests\u00a0{28}"}}],"article-number":"433"}}