학술논문
Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study).
Document Type
Academic Journal
Author
Corsini I; Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy. corsiniiuri@gmail.com.; Rodriguez-Fanjul J; Neonatal Intensive Care Unit. Hospital Germans Trias I Pujol, Badalona, Spain.; Raimondi F; Division of Neonatology, Federico II University of Naples, Naples, Italy.; Boni L; SC Epidemiologia Clinica IRCCS Ospedale Policlinico San Martino, Genoa, Italy.; Berardi A; Neonatal Intensive Care Unit, Policlinico Universitario Modena, Modena, Italy.; Aldecoa-Bilbao V; Neonatal Intensive Care Unit, Hospital Clínic Barcelona, BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine), Barcelona, Spain.; Alonso-Ojembarrena A; Neonatal Intensive Care Unit, Hospital Puerta del Mar, Cadiz, Spain.; Ancora G; Neonatal Intensive Care Unit, Ospedale Infermi Di Rimini, Rimini, Italy.; Aversa S; Neonatal Intensive Care Unit, Children's Hospital, ASST Spedali Civili, Brescia, Italy.; Beghini R; Neonatal Intensive Care Unit, AOUI Verona, Verona, Italy.; Meseguer NB; Neonatal Intensive Care Unit, Hospital Basurto, Bilbao, Spain.; Capasso L; Division of Neonatology, Federico II University of Naples, Naples, Italy.; Chesi F; Neonatal Intensive Care Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.; Ciarcià M; Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.; Concheiro A; Neonatal Intensive Care Unit, Hospital Alvaro Cunqueiro, Vigo, Spain.; Corvaglia L; Neonatal Intensive Care Unit IRCCS AUOBO, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.; Ficial B; Neonatal Intensive Care Unit, AOUI Verona, Verona, Italy.; Filippi L; Neonatal Intensive Care Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.; Carballal JF; Neonatal Intensive Care Unit, Complexo Hospitalario Universitario de A Coruña (CHUAC), Coruña, Spain.; Fusco M; Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.; Gatto S; Neonatal Intensive Care Unit, Ospedale Dei Bambini 'V.Buzzi', Milan, Italy.; Ginovart G; Neonatal Intensive Care Unit. Hospital Germans Trias I Pujol, Badalona, Spain.; Gregorio-Hernández R; Neonatal Intensive Care Unit, Hospital Gregorio Marañon, Madrid, Spain.; Lista G; Neonatal Intensive Care Unit, Ospedale Dei Bambini 'V.Buzzi', Milan, Italy.; Sánchez-Luna M; Neonatal Intensive Care Unit, Hospital Gregorio Marañon, Madrid, Spain.; Martini S; Neonatal Intensive Care Unit IRCCS AUOBO, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.; Massenzi L; Neonatal Intensive Care Unit, Bolzano, Italy.; Miselli F; Neonatal Intensive Care Unit, Policlinico Universitario Modena, Modena, Italy.; Mercadante D; Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; Mosca F; Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.; Palacio MT; Neonatal Intensive Care Unit, Hospital Clínic Barcelona, BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine), Barcelona, Spain.; Perri A; Neonatal Intensive Care Unit, Policlinico Gemelli, Rome, Italy.; Piano F; Neonatal Intensive Care Unit, Ospedale Infermi Di Rimini, Rimini, Italy.; Prieto MP; Neonatal Intensive Care Unit, Hospital Alvaro Cunqueiro, Vigo, Spain.; Fernandez LR; Neonatal Intensive Care Unit, Hospital Basurto, Bilbao, Spain.; Risso FM; Neonatal Intensive Care Unit, Children's Hospital, ASST Spedali Civili, Brescia, Italy.; Savoia M; Neonatal Intensive Care Unit, Udine, Italy.; Staffler A; Neonatal Intensive Care Unit, Bolzano, Italy.; Vento G; Neonatal Intensive Care Unit, Policlinico Gemelli, Rome, Italy.; Dani C; Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
Subject
Language
English
Abstract
Background: The management of respiratory distress syndrome (RDS) in premature newborns is based on different types of non-invasive respiratory support and on surfactant replacement therapy (SRT) to avoid mechanical ventilation as it may eventually result in lung damage. European guidelines currently recommend SRT only when the fraction of inspired oxygen (FiO 2 ) exceeds 0.30. The literature describes that early SRT decreases the risk of bronchopulmonary dysplasia (BPD) and mortality. Lung ultrasound score (LUS) in preterm infants affected by RDS has proven to be able to predict the need for SRT and different single-center studies have shown that LUS may increase the proportion of infants that received early SRT. Therefore, the aim of this study is to determine if the use of LUS as a decision tool for SRT in preterm infants affected by RDS allows for the reduction of the incidence of BPD or death in the study group.
Methods/design: In this study, 668 spontaneously-breathing preterm infants, born at 25+0 to 29 +6 weeks' gestation, in nasal continuous positive airway pressure (nCPAP) will be randomized to receive SRT only when the FiO2 cut-off exceeds 0.3 (control group) or if the LUS score is higher than 8 or the FiO2 requirements exceed 0.3 (study group) (334 infants per arm). The primary outcome will be the difference in proportion of infants with BPD or death in the study group managed compared to the control group.
Discussion: Based on previous published studies, it seems that LUS may decrease the time to administer surfactant therapy. It is known that early surfactant administration decreases BPD and mortality. Therefore, there is rationale for hypothesizing a reduction in BPD or death in the group of patients in which the decision to administer exogenous surfactant is based on lung ultrasound scores.
Trial Registration: ClinicalTrials.gov identifier NCT05198375 . Registered on 20 January 2022.
(© 2023. The Author(s).)
Methods/design: In this study, 668 spontaneously-breathing preterm infants, born at 25
Discussion: Based on previous published studies, it seems that LUS may decrease the time to administer surfactant therapy. It is known that early surfactant administration decreases BPD and mortality. Therefore, there is rationale for hypothesizing a reduction in BPD or death in the group of patients in which the decision to administer exogenous surfactant is based on lung ultrasound scores.
Trial Registration: ClinicalTrials.gov identifier NCT05198375 . Registered on 20 January 2022.
(© 2023. The Author(s).)