Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial.


Journal

JAMA network open
ISSN: 2574-3805
Titre abrégé: JAMA Netw Open
Pays: United States
ID NLM: 101729235

Informations de publication

Date de publication:
03 Sep 2024
Historique:
medline: 25 9 2024
pubmed: 25 9 2024
entrez: 25 9 2024
Statut: epublish

Résumé

A multicenter randomized clinical trial (RCT) showed a lung recruitment maneuver using high-frequency oscillatory ventilation just before surfactant administration (ie, intubate-recruit-surfactant-extubate [IN-REC-SUR-E]) improved the efficacy of treatment compared with the standard intubate-surfactant-extubate (IN-SUR-E) technique without increasing the risk of adverse neonatal outcomes. To examine follow-up outcomes at corrected postnatal age (cPNA) 2 years of preterm infants previously enrolled in an RCT and treated with IN-REC-SUR-E or IN-SUR-E in 35 tertiary neonatal intensive care units. This was a follow-up study of infants recruited into the primary RCT from 2015 to 2018 at 35 tertiary neonatal intensive care units (NICUs) in Italy. Follow-up examinations included neurodevelopmental, growth, and respiratory outcomes of these children at cPNA 2 years. Participants included spontaneously breathing extremely preterm neonates (24 0/7 to 27 6/7 weeks' gestation) reaching failure criteria for continuous positive airway pressure within the first 24 hours of life. Data were analyzed from April 2023 to January 2024. Infants were randomly assigned (1:1) to IN-REC-SUR-E or IN-SUR-E and then followed up. The primary outcome was the occurrence of death after discharge or major disability at cPNA 2 years. Secondary outcomes were neurodevelopmental outcomes (major disability, cerebral palsy, cognitive impairment, visual deficit, or auditory deficit), anthropometric measurements (weight, length, and head circumference), and recurrent respiratory infections and hospitalizations because of respiratory causes at 2y cPNA. A total of 137 extremely preterm infants (median [IQR] gestational age, 26.5 [25.3-27.5] weeks and 75 [54.7%] female), initially enrolled in the original RCT, were followed up at cPNA 2 years, including 64 infants in the IN-SUR-E group and 73 infants in the IN-REC-SUR-E group. There were no significant differences in the occurrence of death after discharge or major disability at cPNA 2 years (IN-SUR-E: 13 children [20.3%] vs IN-REC-SUR-E: 10 children [13.7%]; P = .36). There were no significant differences in incidence of disability, cerebral palsy, or cognitive impairment in the IN-REC-SUR-E group compared with the IN-SUR-E group. There were no significant differences in anthropometric measurements (weight, length, and head circumference) between groups. There were no significant differences in the incidence of recurrent respiratory infections or in hospitalizations because of respiratory causes between groups. In this RCT of lung recruitment before surfactant vs standard care there were no significant differences between the 2 groups in death, neurodevelopmental outcomes, anthropometric measurements, or recurrent respiratory infections at the 2-year follow-up. These findings can aid clinicians in decision-making for the best strategy to administer surfactant, considering long-term outcomes.

Identifiants

pubmed: 39320892
pii: 2824052
doi: 10.1001/jamanetworkopen.2024.35347
doi:

Substances chimiques

Pulmonary Surfactants 0

Types de publication

Journal Article Randomized Controlled Trial Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

e2435347

Auteurs

Francesca Gallini (F)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Dipartimento di Scienze della Vita e Sanità Pubblica, Facoltà di Medicina e Chirurgia, Università Cattolica del Sacro Cuore, Rome, Italy.
Neonatology Unit, Ospedale Isola Tiberina, Gemelli Isola, Rome, Italy.

Domenico Umberto De Rose (DU)

Neonatal Intensive Care Unit, Bambino Gesù Children's Hospital Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Roberta Iuliano (R)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Domenico Marco Romeo (DM)

Pediatric Neurology Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Milena Tana (M)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Angela Paladini (A)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Francesca Paola Fusco (FP)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Stefano Nobile (S)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Francesco Cota (F)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Chiara Tirone (C)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Claudia Aurilia (C)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Alessandra Lio (A)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Alice Esposito (A)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Simonetta Costa (S)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Vito D'Andrea (V)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Maria Luisa Ventura (ML)

Fondazione Monza e Brianza per il Bambino e la sua Mamma, Ospedale San Gerardo, Monza, Italy.

Virgilio Carnielli (V)

Division of Neonatology, Department of Clinical Sciences, Polytechnic University of Marche and Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italy.

Carlo Dani (C)

Department of Mother and Child Health, Division of Neonatology and Neonatal Intensive Care Unit, Careggi University Hospital, Florence, Italy.

Fabio Mosca (F)

Department of Clinical Sciences and Community Health, University of Milan, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.

Monica Fumagalli (M)

Department of Clinical Sciences and Community Health, University of Milan, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.

Gianfranco Scarpelli (G)

Azienda Ospedaliera Cosenza, Cosenza, Italy.

Lucio Giordano (L)

Ospedale Pineta Grande, Castel Volturno, Italy.

Valeria Fasolato (V)

Azienda Ospedaliera Carlo Poma, Mantova, Italy.

Flavia Petrillo (F)

Dipartimento Materno Infantile ASL Bari, Ospedale Di Venere, Bari, Italy.

Pasqua Betta (P)

Azienda Ospedaliera-Universitaria Policlinico Vittorio Emanuele, Presidio Ospedaliero Gaspare Rodolico, Catania, Italy.

Agostina Solinas (A)

Azienda Ospedaliera-Universitaria, Ferrara, Italy.

Eloisa Gitto (E)

Università degli Studi, Messina, Italy.

Giancarlo Gargano (G)

Azienda Unità Sanitaria Locale, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.

Giovanna Mescoli (G)

Ospedale Maggiore, Bologna, Italy.

Stefano Martinelli (S)

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Sandra Di Fabio (S)

Ospedale San Salvatore, L'Aquila, Italy.

Italo Bernardo (I)

Azienda Ospedaliera S. Anna e S. Sebastiano, Caserta, Italy.

Lucia Gabriella Tina (LG)

Azienda ospedaliera di rilievo nazionale e di alta specializzazione Garibaldi, Catania, Italy.

Alex Staffler (A)

Ospedale di Bolzano, Bolzano, Italy.

Ilaria Stasi (I)

Ospedale Maggiore, Novara, Italy.

Isabella Mondello (I)

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.

Eleonora Scapillati (E)

Ospedale Fatebenefratelli-San Pietro, Rome, Italy.

Stefania Vedovato (S)

Ospedale San Bortolo, Vicenza, Italy.

Gianfranco Maffei (G)

Azienda Ospedaliera-Universitaria Ospedali Riuniti, Foggia, Italy.

Adriano Bove (A)

Azienda Ospedaliera Vito Fazzi, Lecce, Italy.

Marcello Vitaliti (M)

Azienda ospedaliera di rilievo nazionale e di alta specializzazione Civico, Palermo, Italy.

Gianluca Terrin (G)

Maternal and Child Health Department, University of Rome Sapienza, Rome, Italy.

Paola Lago (P)

Ospedale Cà Foncello, Treviso, Italy.

Camilla Gizzi (C)

Ospedale Sandro Pertini, Rome, Italy.

Chiara Strozzi (C)

Ospedale Civile SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.

Paolo Ernesto Villani (PE)

Fondazione Poliambulanza, Brescia, Italy.

Alberto Berardi (A)

Azienda Ospedaliera-Universitaria Policlinico, Modena, Italy.

Caterina Cacace (C)

Ospedale Barone Romeo, Patti, Italy.

Giorgio Bracaglia (G)

Ospedale Belcolle, Viterbo, Italy.

Eleonora Pascucci (E)

Section of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.

Filip Cools (F)

Department of Neonatology, Universitair Ziekenhuis Brussel, Brussels, Belgium.

Jane J Pillow (JJ)

Centre for Child Health Research and School of Human Sciences, The University of Western Australia, Perth, Australia.

Graeme Polglase (G)

The Ritchie Centre Hudson Institute of Medical Research and Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.

Roberta Pastorino (R)

Section of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Department of Woman and Child Health and Public Health-Public Health Area, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Anton H van Kaam (AH)

Department of Neonatology, Emma Children's Hospital, Amsterdam University Medical Center, University of Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.

Eugenio Mercuri (E)

Pediatric Neurology Unit, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Luigi Orfeo (L)

Neonatology Unit, Ospedale Isola Tiberina, Gemelli Isola, Rome, Italy.

Giovanni Vento (G)

Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario Agostino Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.
Dipartimento di Scienze della Vita e Sanità Pubblica, Facoltà di Medicina e Chirurgia, Università Cattolica del Sacro Cuore, Rome, Italy.

Silvia Malguzzi (S)

Fondazione Monza e Brianza per il Bambino e la sua Mamma, Ospedale San Gerardo, Monza, Italy.

Camilla Rigotti (C)

Fondazione Monza e Brianza per il Bambino e la sua Mamma, Ospedale San Gerardo, Monza, Italy.

Alessandra Cecchi (A)

Department of Mother and Child Health, Division of Neonatology and Neonatal Intensive Care Unit, Careggi University Hospital, Florence, Italy.

Gabriella Nigro (G)

Azienda Ospedaliera Cosenza, Cosenza, Italy.

Carmine Deni Costabile (CD)

Azienda Ospedaliera Cosenza, Cosenza, Italy.

Enza Roma (E)

Ospedale Pineta Grande, Castel Volturno, Italy.

Paola Sindico (P)

Azienda Ospedaliera Carlo Poma, Mantova, Italy.

Rita Venafra (R)

Dipartimento Materno Infantile ASL Bari, Ospedale Di Venere, Bari, Italy.

Carmine Mattia (C)

Azienda Ospedaliera-Universitaria Policlinico Vittorio Emanuele, Presidio Ospedaliero Gaspare Rodolico, Catania, Italy.

Maria Conversano (M)

Azienda Ospedaliera-Universitaria Policlinico Vittorio Emanuele, Presidio Ospedaliero Gaspare Rodolico, Catania, Italy.

Elisa Ballardini (E)

Azienda Ospedaliera-Universitaria, Ferrara, Italy.

Alessandro Manganaro (A)

Università degli Studi, Messina, Italy.

Eleonora Balestri (E)

Azienda Unità Sanitaria Locale, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.

Claudio Gallo (C)

Azienda Unità Sanitaria Locale, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.

Piero Catenazzi (P)

Ospedale Maggiore, Bologna, Italy.

Maria Graziana Astori (MG)

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Eugenia Maranella (E)

Ospedale San Salvatore, L'Aquila, Italy.

Carolina Grassia (C)

Azienda Ospedaliera S. Anna e S. Sebastiano, Caserta, Italy.

Kim Maiolo (K)

Azienda ospedaliera di rilievo nazionale e di alta specializzazione Garibaldi, Catania, Italy.

Danilo Castellano (D)

Azienda ospedaliera di rilievo nazionale e di alta specializzazione Garibaldi, Catania, Italy.

Luca Massenzi (L)

Ospedale di Bolzano, Bolzano, Italy.

Elisabetta Chiodin (E)

Ospedale di Bolzano, Bolzano, Italy.

Maria Rita Gallina (MR)

Ospedale Maggiore, Novara, Italy.

Chiara Consigli (C)

Ospedale Fatebenefratelli-San Pietro, Rome, Italy.

Elena Sorrentino (E)

Ospedale Fatebenefratelli-San Pietro, Rome, Italy.

Silvia Bonato (S)

Ospedale San Bortolo, Vicenza, Italy.

Monica Mancini (M)

Azienda Ospedaliera-Universitaria Ospedali Riuniti, Foggia, Italy.

Roberto Perniola (R)

Azienda Ospedaliera Vito Fazzi, Lecce, Italy.

Silvia Giannuzzo (S)

Azienda Ospedaliera Vito Fazzi, Lecce, Italy.

Elisa Tranchina (E)

Azienda ospedaliera di rilievo nazionale e di alta specializzazione Civico, Palermo, Italy.

Viviana Cardilli (V)

Maternal and Child Health Department, University of Rome Sapienza, Rome, Italy.

Lucia Dito (L)

Maternal and Child Health Department, University of Rome Sapienza, Rome, Italy.

Daniela Regoli (D)

Maternal and Child Health Department, University of Rome Sapienza, Rome, Italy.

Francesca Tormena (F)

Ospedale Cà Foncello, Treviso, Italy.

Nadia Battajon (N)

Ospedale Cà Foncello, Treviso, Italy.

Roberta Arena (R)

Neonatology Unit, Ospedale Isola Tiberina, Gemelli Isola, Rome, Italy.

Benedetta Allais (B)

Fondazione Poliambulanza, Brescia, Italy.

Isotta Guidotti (I)

Azienda Ospedaliera-Universitaria Policlinico, Modena, Italy.

Federica Roversi (F)

Azienda Ospedaliera-Universitaria Policlinico, Modena, Italy.

Valerio Meli (V)

Ospedale Barone Romeo, Patti, Italy.

Viviana Tulino (V)

Ospedale Barone Romeo, Patti, Italy.

Alessandra Casati (A)

Ospedale Belcolle, Viterbo, Italy.

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