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


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
04 Nov 2023
Historique:
received: 19 05 2023
accepted: 24 10 2023
medline: 6 11 2023
pubmed: 5 11 2023
entrez: 5 11 2023
Statut: epublish

Résumé

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 In this study, 668 spontaneously-breathing preterm infants, born at 25 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. ClinicalTrials.gov identifier NCT05198375 . Registered on 20 January 2022.

Sections du résumé

BACKGROUND 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
METHODS/DESIGN METHODS
In this study, 668 spontaneously-breathing preterm infants, born at 25
DISCUSSION CONCLUSIONS
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 BACKGROUND
ClinicalTrials.gov identifier NCT05198375 . Registered on 20 January 2022.

Identifiants

pubmed: 37925512
doi: 10.1186/s13063-023-07745-8
pii: 10.1186/s13063-023-07745-8
pmc: PMC10625281
doi:

Substances chimiques

Oxygen S88TT14065
Pulmonary Surfactants 0
Surface-Active Agents 0

Banques de données

ClinicalTrials.gov
['NCT05198375']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

706

Informations de copyright

© 2023. The Author(s).

Références

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Auteurs

Iuri Corsini (I)

Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy. corsiniiuri@gmail.com.

Javier Rodriguez-Fanjul (J)

Neonatal Intensive Care Unit. Hospital Germans Trias I Pujol, Badalona, Spain.

Francesco Raimondi (F)

Division of Neonatology, Federico II University of Naples, Naples, Italy.

Luca Boni (L)

SC Epidemiologia Clinica IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Alberto Berardi (A)

Neonatal Intensive Care Unit, Policlinico Universitario Modena, Modena, Italy.

Victoria Aldecoa-Bilbao (V)

Neonatal Intensive Care Unit, Hospital Clínic Barcelona, BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine), Barcelona, Spain.

Almudena Alonso-Ojembarrena (A)

Neonatal Intensive Care Unit, Hospital Puerta del Mar, Cadiz, Spain.

Gina Ancora (G)

Neonatal Intensive Care Unit, Ospedale Infermi Di Rimini, Rimini, Italy.

Salvatore Aversa (S)

Neonatal Intensive Care Unit, Children's Hospital, ASST Spedali Civili, Brescia, Italy.

Renzo Beghini (R)

Neonatal Intensive Care Unit, AOUI Verona, Verona, Italy.

Nerea Bilbao Meseguer (NB)

Neonatal Intensive Care Unit, Hospital Basurto, Bilbao, Spain.

Letizia Capasso (L)

Division of Neonatology, Federico II University of Naples, Naples, Italy.

Francesca Chesi (F)

Neonatal Intensive Care Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Martina Ciarcià (M)

Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Ana Concheiro (A)

Neonatal Intensive Care Unit, Hospital Alvaro Cunqueiro, Vigo, Spain.

Luigi Corvaglia (L)

Neonatal Intensive Care Unit IRCCS AUOBO, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Benjamim Ficial (B)

Neonatal Intensive Care Unit, AOUI Verona, Verona, Italy.

Luca Filippi (L)

Neonatal Intensive Care Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Jesus Fuentes Carballal (JF)

Neonatal Intensive Care Unit, Complexo Hospitalario Universitario de A Coruña (CHUAC), Coruña, Spain.

Monica Fusco (M)

Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Sara Gatto (S)

Neonatal Intensive Care Unit, Ospedale Dei Bambini "V.Buzzi", Milan, Italy.

Gemma Ginovart (G)

Neonatal Intensive Care Unit. Hospital Germans Trias I Pujol, Badalona, Spain.

Rebeca Gregorio-Hernández (R)

Neonatal Intensive Care Unit, Hospital Gregorio Marañon, Madrid, Spain.

Gianluca Lista (G)

Neonatal Intensive Care Unit, Ospedale Dei Bambini "V.Buzzi", Milan, Italy.

Manuel Sánchez-Luna (M)

Neonatal Intensive Care Unit, Hospital Gregorio Marañon, Madrid, Spain.

Silvia Martini (S)

Neonatal Intensive Care Unit IRCCS AUOBO, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Luca Massenzi (L)

Neonatal Intensive Care Unit, Bolzano, Italy.

Francesca Miselli (F)

Neonatal Intensive Care Unit, Policlinico Universitario Modena, Modena, Italy.

Domenica Mercadante (D)

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Fabio 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.

Marta Teresa Palacio (MT)

Neonatal Intensive Care Unit, Hospital Clínic Barcelona, BCNatal (Barcelona Center for Maternal Fetal and Neonatal Medicine), Barcelona, Spain.

Alessandro Perri (A)

Neonatal Intensive Care Unit, Policlinico Gemelli, Rome, Italy.

Francesca Piano (F)

Neonatal Intensive Care Unit, Ospedale Infermi Di Rimini, Rimini, Italy.

Marcelino Pumarada Prieto (MP)

Neonatal Intensive Care Unit, Hospital Alvaro Cunqueiro, Vigo, Spain.

Lorena Rodeno Fernandez (LR)

Neonatal Intensive Care Unit, Hospital Basurto, Bilbao, Spain.

Francesco Maria Risso (FM)

Neonatal Intensive Care Unit, Children's Hospital, ASST Spedali Civili, Brescia, Italy.

Marilena Savoia (M)

Neonatal Intensive Care Unit, Udine, Italy.

Alex Staffler (A)

Neonatal Intensive Care Unit, Bolzano, Italy.

Giovanni Vento (G)

Neonatal Intensive Care Unit, Policlinico Gemelli, Rome, Italy.

Carlo Dani (C)

Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.

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