Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)

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. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Corsini, Iuri [verfasserIn] Rodriguez-Fanjul, Javier Raimondi, Francesco Boni, Luca Berardi, Alberto Aldecoa-Bilbao, Victoria Alonso-Ojembarrena, Almudena Ancora, Gina Aversa, Salvatore Beghini, Renzo Meseguer, Nerea Bilbao Capasso, Letizia Chesi, Francesca Ciarcià, Martina Concheiro, Ana Corvaglia, Luigi Ficial, Benjamim Filippi, Luca Carballal, Jesus Fuentes Fusco, Monica Gatto, Sara Ginovart, Gemma Gregorio-Hernández, Rebeca Lista, Gianluca Sánchez-Luna, Manuel Martini, Silvia Massenzi, Luca Miselli, Francesca Mercadante, Domenica Mosca, Fabio Palacio, Marta Teresa Perri, Alessandro Piano, Francesca Prieto, Marcelino Pumarada Fernandez, Lorena Rodeno Risso, Francesco Maria Savoia, Marilena Staffler, Alex Vento, Giovanni Dani, Carlo

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2023

Schlagwörter:	Preterm infants Lung ultrasound Respiratory distress syndrome Surfactant therapy

Anmerkung:	© The Author(s) 2023

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 24(2023), 1 vom: 04. Nov.
Übergeordnetes Werk:	volume:24 ; year:2023 ; number:1 ; day:04 ; month:11

Links:	Volltext

DOI / URN:	10.1186/s13063-023-07745-8

Katalog-ID:	SPR053634691

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520			\|a 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.
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allfields	10.1186/s13063-023-07745-8 doi (DE-627)SPR053634691 (SPR)s13063-023-07745-8-e DE-627 ger DE-627 rakwb eng Corsini, Iuri verfasserin (orcid)0000-0002-3146-1446 aut Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 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. Preterm infants (dpeaa)DE-He213 Lung ultrasound (dpeaa)DE-He213 Respiratory distress syndrome (dpeaa)DE-He213 Surfactant therapy (dpeaa)DE-He213 Rodriguez-Fanjul, Javier aut Raimondi, Francesco aut Boni, Luca aut Berardi, Alberto aut Aldecoa-Bilbao, Victoria aut Alonso-Ojembarrena, Almudena aut Ancora, Gina aut Aversa, Salvatore aut Beghini, Renzo aut Meseguer, Nerea Bilbao aut Capasso, Letizia aut Chesi, Francesca aut Ciarcià, Martina aut Concheiro, Ana aut Corvaglia, Luigi aut Ficial, Benjamim aut Filippi, Luca aut Carballal, Jesus Fuentes aut Fusco, Monica aut Gatto, Sara aut Ginovart, Gemma aut Gregorio-Hernández, Rebeca aut Lista, Gianluca aut Sánchez-Luna, Manuel aut Martini, Silvia aut Massenzi, Luca aut Miselli, Francesca aut Mercadante, Domenica aut Mosca, Fabio aut Palacio, Marta Teresa aut Perri, Alessandro aut Piano, Francesca aut Prieto, Marcelino Pumarada aut Fernandez, Lorena Rodeno aut Risso, Francesco Maria aut Savoia, Marilena aut Staffler, Alex aut Vento, Giovanni aut Dani, Carlo aut Enthalten in Trials London : BioMed Central, 2000 24(2023), 1 vom: 04. Nov. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:24 year:2023 number:1 day:04 month:11 https://dx.doi.org/10.1186/s13063-023-07745-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 04 11
spelling	10.1186/s13063-023-07745-8 doi (DE-627)SPR053634691 (SPR)s13063-023-07745-8-e DE-627 ger DE-627 rakwb eng Corsini, Iuri verfasserin (orcid)0000-0002-3146-1446 aut Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 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. Preterm infants (dpeaa)DE-He213 Lung ultrasound (dpeaa)DE-He213 Respiratory distress syndrome (dpeaa)DE-He213 Surfactant therapy (dpeaa)DE-He213 Rodriguez-Fanjul, Javier aut Raimondi, Francesco aut Boni, Luca aut Berardi, Alberto aut Aldecoa-Bilbao, Victoria aut Alonso-Ojembarrena, Almudena aut Ancora, Gina aut Aversa, Salvatore aut Beghini, Renzo aut Meseguer, Nerea Bilbao aut Capasso, Letizia aut Chesi, Francesca aut Ciarcià, Martina aut Concheiro, Ana aut Corvaglia, Luigi aut Ficial, Benjamim aut Filippi, Luca aut Carballal, Jesus Fuentes aut Fusco, Monica aut Gatto, Sara aut Ginovart, Gemma aut Gregorio-Hernández, Rebeca aut Lista, Gianluca aut Sánchez-Luna, Manuel aut Martini, Silvia aut Massenzi, Luca aut Miselli, Francesca aut Mercadante, Domenica aut Mosca, Fabio aut Palacio, Marta Teresa aut Perri, Alessandro aut Piano, Francesca aut Prieto, Marcelino Pumarada aut Fernandez, Lorena Rodeno aut Risso, Francesco Maria aut Savoia, Marilena aut Staffler, Alex aut Vento, Giovanni aut Dani, Carlo aut Enthalten in Trials London : BioMed Central, 2000 24(2023), 1 vom: 04. Nov. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:24 year:2023 number:1 day:04 month:11 https://dx.doi.org/10.1186/s13063-023-07745-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 04 11
allfields_unstemmed	10.1186/s13063-023-07745-8 doi (DE-627)SPR053634691 (SPR)s13063-023-07745-8-e DE-627 ger DE-627 rakwb eng Corsini, Iuri verfasserin (orcid)0000-0002-3146-1446 aut Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 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. Preterm infants (dpeaa)DE-He213 Lung ultrasound (dpeaa)DE-He213 Respiratory distress syndrome (dpeaa)DE-He213 Surfactant therapy (dpeaa)DE-He213 Rodriguez-Fanjul, Javier aut Raimondi, Francesco aut Boni, Luca aut Berardi, Alberto aut Aldecoa-Bilbao, Victoria aut Alonso-Ojembarrena, Almudena aut Ancora, Gina aut Aversa, Salvatore aut Beghini, Renzo aut Meseguer, Nerea Bilbao aut Capasso, Letizia aut Chesi, Francesca aut Ciarcià, Martina aut Concheiro, Ana aut Corvaglia, Luigi aut Ficial, Benjamim aut Filippi, Luca aut Carballal, Jesus Fuentes aut Fusco, Monica aut Gatto, Sara aut Ginovart, Gemma aut Gregorio-Hernández, Rebeca aut Lista, Gianluca aut Sánchez-Luna, Manuel aut Martini, Silvia aut Massenzi, Luca aut Miselli, Francesca aut Mercadante, Domenica aut Mosca, Fabio aut Palacio, Marta Teresa aut Perri, Alessandro aut Piano, Francesca aut Prieto, Marcelino Pumarada aut Fernandez, Lorena Rodeno aut Risso, Francesco Maria aut Savoia, Marilena aut Staffler, Alex aut Vento, Giovanni aut Dani, Carlo aut Enthalten in Trials London : BioMed Central, 2000 24(2023), 1 vom: 04. Nov. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:24 year:2023 number:1 day:04 month:11 https://dx.doi.org/10.1186/s13063-023-07745-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 04 11
allfieldsGer	10.1186/s13063-023-07745-8 doi (DE-627)SPR053634691 (SPR)s13063-023-07745-8-e DE-627 ger DE-627 rakwb eng Corsini, Iuri verfasserin (orcid)0000-0002-3146-1446 aut Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 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. Preterm infants (dpeaa)DE-He213 Lung ultrasound (dpeaa)DE-He213 Respiratory distress syndrome (dpeaa)DE-He213 Surfactant therapy (dpeaa)DE-He213 Rodriguez-Fanjul, Javier aut Raimondi, Francesco aut Boni, Luca aut Berardi, Alberto aut Aldecoa-Bilbao, Victoria aut Alonso-Ojembarrena, Almudena aut Ancora, Gina aut Aversa, Salvatore aut Beghini, Renzo aut Meseguer, Nerea Bilbao aut Capasso, Letizia aut Chesi, Francesca aut Ciarcià, Martina aut Concheiro, Ana aut Corvaglia, Luigi aut Ficial, Benjamim aut Filippi, Luca aut Carballal, Jesus Fuentes aut Fusco, Monica aut Gatto, Sara aut Ginovart, Gemma aut Gregorio-Hernández, Rebeca aut Lista, Gianluca aut Sánchez-Luna, Manuel aut Martini, Silvia aut Massenzi, Luca aut Miselli, Francesca aut Mercadante, Domenica aut Mosca, Fabio aut Palacio, Marta Teresa aut Perri, Alessandro aut Piano, Francesca aut Prieto, Marcelino Pumarada aut Fernandez, Lorena Rodeno aut Risso, Francesco Maria aut Savoia, Marilena aut Staffler, Alex aut Vento, Giovanni aut Dani, Carlo aut Enthalten in Trials London : BioMed Central, 2000 24(2023), 1 vom: 04. Nov. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:24 year:2023 number:1 day:04 month:11 https://dx.doi.org/10.1186/s13063-023-07745-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 04 11
allfieldsSound	10.1186/s13063-023-07745-8 doi (DE-627)SPR053634691 (SPR)s13063-023-07745-8-e DE-627 ger DE-627 rakwb eng Corsini, Iuri verfasserin (orcid)0000-0002-3146-1446 aut Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) 2023 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2023 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. Preterm infants (dpeaa)DE-He213 Lung ultrasound (dpeaa)DE-He213 Respiratory distress syndrome (dpeaa)DE-He213 Surfactant therapy (dpeaa)DE-He213 Rodriguez-Fanjul, Javier aut Raimondi, Francesco aut Boni, Luca aut Berardi, Alberto aut Aldecoa-Bilbao, Victoria aut Alonso-Ojembarrena, Almudena aut Ancora, Gina aut Aversa, Salvatore aut Beghini, Renzo aut Meseguer, Nerea Bilbao aut Capasso, Letizia aut Chesi, Francesca aut Ciarcià, Martina aut Concheiro, Ana aut Corvaglia, Luigi aut Ficial, Benjamim aut Filippi, Luca aut Carballal, Jesus Fuentes aut Fusco, Monica aut Gatto, Sara aut Ginovart, Gemma aut Gregorio-Hernández, Rebeca aut Lista, Gianluca aut Sánchez-Luna, Manuel aut Martini, Silvia aut Massenzi, Luca aut Miselli, Francesca aut Mercadante, Domenica aut Mosca, Fabio aut Palacio, Marta Teresa aut Perri, Alessandro aut Piano, Francesca aut Prieto, Marcelino Pumarada aut Fernandez, Lorena Rodeno aut Risso, Francesco Maria aut Savoia, Marilena aut Staffler, Alex aut Vento, Giovanni aut Dani, Carlo aut Enthalten in Trials London : BioMed Central, 2000 24(2023), 1 vom: 04. Nov. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:24 year:2023 number:1 day:04 month:11 https://dx.doi.org/10.1186/s13063-023-07745-8 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 24 2023 1 04 11
language	English
source	Enthalten in Trials 24(2023), 1 vom: 04. Nov. volume:24 year:2023 number:1 day:04 month:11
sourceStr	Enthalten in Trials 24(2023), 1 vom: 04. Nov. volume:24 year:2023 number:1 day:04 month:11
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Preterm infants Lung ultrasound Respiratory distress syndrome Surfactant therapy
isfreeaccess_bool	true
container_title	Trials
authorswithroles_txt_mv	Corsini, Iuri @@aut@@ Rodriguez-Fanjul, Javier @@aut@@ Raimondi, Francesco @@aut@@ Boni, Luca @@aut@@ Berardi, Alberto @@aut@@ Aldecoa-Bilbao, Victoria @@aut@@ Alonso-Ojembarrena, Almudena @@aut@@ Ancora, Gina @@aut@@ Aversa, Salvatore @@aut@@ Beghini, Renzo @@aut@@ Meseguer, Nerea Bilbao @@aut@@ Capasso, Letizia @@aut@@ Chesi, Francesca @@aut@@ Ciarcià, Martina @@aut@@ Concheiro, Ana @@aut@@ Corvaglia, Luigi @@aut@@ Ficial, Benjamim @@aut@@ Filippi, Luca @@aut@@ Carballal, Jesus Fuentes @@aut@@ Fusco, Monica @@aut@@ Gatto, Sara @@aut@@ Ginovart, Gemma @@aut@@ Gregorio-Hernández, Rebeca @@aut@@ Lista, Gianluca @@aut@@ Sánchez-Luna, Manuel @@aut@@ Martini, Silvia @@aut@@ Massenzi, Luca @@aut@@ Miselli, Francesca @@aut@@ Mercadante, Domenica @@aut@@ Mosca, Fabio @@aut@@ Palacio, Marta Teresa @@aut@@ Perri, Alessandro @@aut@@ Piano, Francesca @@aut@@ Prieto, Marcelino Pumarada @@aut@@ Fernandez, Lorena Rodeno @@aut@@ Risso, Francesco Maria @@aut@@ Savoia, Marilena @@aut@@ Staffler, Alex @@aut@@ Vento, Giovanni @@aut@@ Dani, Carlo @@aut@@
publishDateDaySort_date	2023-11-04T00:00:00Z
hierarchy_top_id	326173552
id	SPR053634691
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">SPR053634691</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20231105064629.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">231105s2023 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-023-07745-8</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR053634691</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-023-07745-8-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Corsini, Iuri</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-3146-1446</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2023</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2023</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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author	Corsini, Iuri
spellingShingle	Corsini, Iuri misc Preterm infants misc Lung ultrasound misc Respiratory distress syndrome misc Surfactant therapy Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
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topic_title	Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study) Preterm infants (dpeaa)DE-He213 Lung ultrasound (dpeaa)DE-He213 Respiratory distress syndrome (dpeaa)DE-He213 Surfactant therapy (dpeaa)DE-He213
topic	misc Preterm infants misc Lung ultrasound misc Respiratory distress syndrome misc Surfactant therapy
topic_unstemmed	misc Preterm infants misc Lung ultrasound misc Respiratory distress syndrome misc Surfactant therapy
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title	Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
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title_full	Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
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author_browse	Corsini, Iuri Rodriguez-Fanjul, Javier Raimondi, Francesco Boni, Luca Berardi, Alberto Aldecoa-Bilbao, Victoria Alonso-Ojembarrena, Almudena Ancora, Gina Aversa, Salvatore Beghini, Renzo Meseguer, Nerea Bilbao Capasso, Letizia Chesi, Francesca Ciarcià, Martina Concheiro, Ana Corvaglia, Luigi Ficial, Benjamim Filippi, Luca Carballal, Jesus Fuentes Fusco, Monica Gatto, Sara Ginovart, Gemma Gregorio-Hernández, Rebeca Lista, Gianluca Sánchez-Luna, Manuel Martini, Silvia Massenzi, Luca Miselli, Francesca Mercadante, Domenica Mosca, Fabio Palacio, Marta Teresa Perri, Alessandro Piano, Francesca Prieto, Marcelino Pumarada Fernandez, Lorena Rodeno Risso, Francesco Maria Savoia, Marilena Staffler, Alex Vento, Giovanni Dani, Carlo
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title_sort	lung ultrasound guided surfactant therapy in preterm infants: an international multicenter randomized control trial (lung study)
title_auth	Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
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. © The Author(s) 2023
abstractGer	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. © The Author(s) 2023
abstract_unstemmed	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. © The Author(s) 2023
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title_short	Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)
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up_date	2024-07-03T20:56:25.917Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000naa a22002652 4500</leader><controlfield tag="001">SPR053634691</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20231105064629.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">231105s2023 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/s13063-023-07745-8</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR053634691</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13063-023-07745-8-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Corsini, Iuri</subfield><subfield code="e">verfasserin</subfield><subfield code="0">(orcid)0000-0002-3146-1446</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2023</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2023</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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Lung UltrasouNd Guided surfactant therapy in preterm infants: an international multicenter randomized control trial (LUNG study)

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