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

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-surfact...

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Veröffentlicht in:JAMA network open 2024-09, Vol.7 (9), p.e2435347
Hauptverfasser: Gallini, Francesca, De Rose, Domenico Umberto, Iuliano, Roberta, Romeo, Domenico Marco, Tana, Milena, Paladini, Angela, Fusco, Francesca Paola, Nobile, Stefano, Cota, Francesco, Tirone, Chiara, Aurilia, Claudia, Lio, Alessandra, Esposito, Alice, Costa, Simonetta, D'Andrea, Vito, Ventura, Maria Luisa, Carnielli, Virgilio, Dani, Carlo, Mosca, Fabio, Fumagalli, Monica, Scarpelli, Gianfranco, Giordano, Lucio, Fasolato, Valeria, Petrillo, Flavia, Betta, Pasqua, Solinas, Agostina, Gitto, Eloisa, Gargano, Giancarlo, Mescoli, Giovanna, Martinelli, Stefano, Di Fabio, Sandra, Bernardo, Italo, Tina, Lucia Gabriella, Staffler, Alex, Stasi, Ilaria, Mondello, Isabella, Scapillati, Eleonora, Vedovato, Stefania, Maffei, Gianfranco, Bove, Adriano, Vitaliti, Marcello, Terrin, Gianluca, Lago, Paola, Gizzi, Camilla, Strozzi, Chiara, Villani, Paolo Ernesto, Berardi, Alberto, Cacace, Caterina, Bracaglia, Giorgio, Pascucci, Eleonora, Cools, Filip, Pillow, Jane J, Polglase, Graeme, Pastorino, Roberta, van Kaam, Anton H, Mercuri, Eugenio, Orfeo, Luigi, Vento, Giovanni, Malguzzi, Silvia, Rigotti, Camilla, Cecchi, Alessandra, Nigro, Gabriella, Costabile, Carmine Deni, Roma, Enza, Sindico, Paola, Venafra, Rita, Mattia, Carmine, Conversano, Maria, Ballardini, Elisa, Manganaro, Alessandro, Balestri, Eleonora, Gallo, Claudio, Catenazzi, Piero, Astori, Maria Graziana, Maranella, Eugenia, Grassia, Carolina, Maiolo, Kim, Castellano, Danilo, Massenzi, Luca, Chiodin, Elisabetta, Gallina, Maria Rita, Consigli, Chiara, Sorrentino, Elena, Bonato, Silvia, Mancini, Monica, Perniola, Roberto, Giannuzzo, Silvia, Tranchina, Elisa, Cardilli, Viviana, Dito, Lucia, Regoli, Daniela, Tormena, Francesca, Battajon, Nadia, Arena, Roberta, Allais, Benedetta, Guidotti, Isotta, Roversi, Federica, Meli, Valerio, Tulino, Viviana, Casati, Alessandra
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container_title JAMA network open
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creator Gallini, Francesca
De Rose, Domenico Umberto
Iuliano, Roberta
Romeo, Domenico Marco
Tana, Milena
Paladini, Angela
Fusco, Francesca Paola
Nobile, Stefano
Cota, Francesco
Tirone, Chiara
Aurilia, Claudia
Lio, Alessandra
Esposito, Alice
Costa, Simonetta
D'Andrea, Vito
Ventura, Maria Luisa
Carnielli, Virgilio
Dani, Carlo
Mosca, Fabio
Fumagalli, Monica
Scarpelli, Gianfranco
Giordano, Lucio
Fasolato, Valeria
Petrillo, Flavia
Betta, Pasqua
Solinas, Agostina
Gitto, Eloisa
Gargano, Giancarlo
Mescoli, Giovanna
Martinelli, Stefano
Di Fabio, Sandra
Bernardo, Italo
Tina, Lucia Gabriella
Staffler, Alex
Stasi, Ilaria
Mondello, Isabella
Scapillati, Eleonora
Vedovato, Stefania
Maffei, Gianfranco
Bove, Adriano
Vitaliti, Marcello
Terrin, Gianluca
Lago, Paola
Gizzi, Camilla
Strozzi, Chiara
Villani, Paolo Ernesto
Berardi, Alberto
Cacace, Caterina
Bracaglia, Giorgio
Pascucci, Eleonora
Cools, Filip
Pillow, Jane J
Polglase, Graeme
Pastorino, Roberta
van Kaam, Anton H
Mercuri, Eugenio
Orfeo, Luigi
Vento, Giovanni
Malguzzi, Silvia
Rigotti, Camilla
Cecchi, Alessandra
Nigro, Gabriella
Costabile, Carmine Deni
Roma, Enza
Sindico, Paola
Venafra, Rita
Mattia, Carmine
Conversano, Maria
Ballardini, Elisa
Manganaro, Alessandro
Balestri, Eleonora
Gallo, Claudio
Catenazzi, Piero
Astori, Maria Graziana
Maranella, Eugenia
Grassia, Carolina
Maiolo, Kim
Castellano, Danilo
Massenzi, Luca
Chiodin, Elisabetta
Gallina, Maria Rita
Consigli, Chiara
Sorrentino, Elena
Bonato, Silvia
Mancini, Monica
Perniola, Roberto
Giannuzzo, Silvia
Tranchina, Elisa
Cardilli, Viviana
Dito, Lucia
Regoli, Daniela
Tormena, Francesca
Battajon, Nadia
Arena, Roberta
Allais, Benedetta
Guidotti, Isotta
Roversi, Federica
Meli, Valerio
Tulino, Viviana
Casati, Alessandra
description 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
doi_str_mv 10.1001/jamanetworkopen.2024.35347
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De Rose, Domenico Umberto ; Iuliano, Roberta ; Romeo, Domenico Marco ; Tana, Milena ; Paladini, Angela ; Fusco, Francesca Paola ; Nobile, Stefano ; Cota, Francesco ; Tirone, Chiara ; Aurilia, Claudia ; Lio, Alessandra ; Esposito, Alice ; Costa, Simonetta ; D'Andrea, Vito ; Ventura, Maria Luisa ; Carnielli, Virgilio ; Dani, Carlo ; Mosca, Fabio ; Fumagalli, Monica ; Scarpelli, Gianfranco ; Giordano, Lucio ; Fasolato, Valeria ; Petrillo, Flavia ; Betta, Pasqua ; Solinas, Agostina ; Gitto, Eloisa ; Gargano, Giancarlo ; Mescoli, Giovanna ; Martinelli, Stefano ; Di Fabio, Sandra ; Bernardo, Italo ; Tina, Lucia Gabriella ; Staffler, Alex ; Stasi, Ilaria ; Mondello, Isabella ; Scapillati, Eleonora ; Vedovato, Stefania ; Maffei, Gianfranco ; Bove, Adriano ; Vitaliti, Marcello ; Terrin, Gianluca ; Lago, Paola ; Gizzi, Camilla ; Strozzi, Chiara ; Villani, Paolo Ernesto ; Berardi, Alberto ; Cacace, Caterina ; Bracaglia, Giorgio ; Pascucci, Eleonora ; Cools, Filip ; Pillow, Jane J ; Polglase, Graeme ; Pastorino, Roberta ; van Kaam, Anton H ; Mercuri, Eugenio ; Orfeo, Luigi ; Vento, Giovanni ; Malguzzi, Silvia ; Rigotti, Camilla ; Cecchi, Alessandra ; Nigro, Gabriella ; Costabile, Carmine Deni ; Roma, Enza ; Sindico, Paola ; Venafra, Rita ; Mattia, Carmine ; Conversano, Maria ; Ballardini, Elisa ; Manganaro, Alessandro ; Balestri, Eleonora ; Gallo, Claudio ; Catenazzi, Piero ; Astori, Maria Graziana ; Maranella, Eugenia ; Grassia, Carolina ; Maiolo, Kim ; Castellano, Danilo ; Massenzi, Luca ; Chiodin, Elisabetta ; Gallina, Maria Rita ; Consigli, Chiara ; Sorrentino, Elena ; Bonato, Silvia ; Mancini, Monica ; Perniola, Roberto ; Giannuzzo, Silvia ; Tranchina, Elisa ; Cardilli, Viviana ; Dito, Lucia ; Regoli, Daniela ; Tormena, Francesca ; Battajon, Nadia ; Arena, Roberta ; Allais, Benedetta ; Guidotti, Isotta ; Roversi, Federica ; Meli, Valerio ; Tulino, Viviana ; Casati, Alessandra</creator><creatorcontrib>Gallini, Francesca ; De Rose, Domenico Umberto ; Iuliano, Roberta ; Romeo, Domenico Marco ; Tana, Milena ; Paladini, Angela ; Fusco, Francesca Paola ; Nobile, Stefano ; Cota, Francesco ; Tirone, Chiara ; Aurilia, Claudia ; Lio, Alessandra ; Esposito, Alice ; Costa, Simonetta ; D'Andrea, Vito ; Ventura, Maria Luisa ; Carnielli, Virgilio ; Dani, Carlo ; Mosca, Fabio ; Fumagalli, Monica ; Scarpelli, Gianfranco ; Giordano, Lucio ; Fasolato, Valeria ; Petrillo, Flavia ; Betta, Pasqua ; Solinas, Agostina ; Gitto, Eloisa ; Gargano, Giancarlo ; Mescoli, Giovanna ; Martinelli, Stefano ; Di Fabio, Sandra ; Bernardo, Italo ; Tina, Lucia Gabriella ; Staffler, Alex ; Stasi, Ilaria ; Mondello, Isabella ; Scapillati, Eleonora ; Vedovato, Stefania ; Maffei, Gianfranco ; Bove, Adriano ; Vitaliti, Marcello ; Terrin, Gianluca ; Lago, Paola ; Gizzi, Camilla ; Strozzi, Chiara ; Villani, Paolo Ernesto ; Berardi, Alberto ; Cacace, Caterina ; Bracaglia, Giorgio ; Pascucci, Eleonora ; Cools, Filip ; Pillow, Jane J ; Polglase, Graeme ; Pastorino, Roberta ; van Kaam, Anton H ; Mercuri, Eugenio ; Orfeo, Luigi ; Vento, Giovanni ; Malguzzi, Silvia ; Rigotti, Camilla ; Cecchi, Alessandra ; Nigro, Gabriella ; Costabile, Carmine Deni ; Roma, Enza ; Sindico, Paola ; Venafra, Rita ; Mattia, Carmine ; Conversano, Maria ; Ballardini, Elisa ; Manganaro, Alessandro ; Balestri, Eleonora ; Gallo, Claudio ; Catenazzi, Piero ; Astori, Maria Graziana ; Maranella, Eugenia ; Grassia, Carolina ; Maiolo, Kim ; Castellano, Danilo ; Massenzi, Luca ; Chiodin, Elisabetta ; Gallina, Maria Rita ; Consigli, Chiara ; Sorrentino, Elena ; Bonato, Silvia ; Mancini, Monica ; Perniola, Roberto ; Giannuzzo, Silvia ; Tranchina, Elisa ; Cardilli, Viviana ; Dito, Lucia ; Regoli, Daniela ; Tormena, Francesca ; Battajon, Nadia ; Arena, Roberta ; Allais, Benedetta ; Guidotti, Isotta ; Roversi, Federica ; Meli, Valerio ; Tulino, Viviana ; Casati, Alessandra ; IN-REC-SUR-E Study Group</creatorcontrib><description>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.</description><identifier>ISSN: 2574-3805</identifier><identifier>EISSN: 2574-3805</identifier><identifier>DOI: 10.1001/jamanetworkopen.2024.35347</identifier><identifier>PMID: 39320892</identifier><language>eng</language><publisher>United States: American Medical Association</publisher><subject>Cerebral palsy ; Child, Preschool ; Clinical trials ; Cognitive ability ; Extubation ; Female ; Follow-Up Studies ; High-Frequency Ventilation - methods ; Humans ; Infant ; Infant, Extremely Premature ; Infant, Newborn ; Infections ; Intensive care ; Intensive Care Units, Neonatal - statistics &amp; numerical data ; Italy ; Male ; Newborn babies ; Online Only ; Original Investigation ; Pediatrics ; Premature babies ; Pulmonary Surfactants - administration &amp; dosage ; Pulmonary Surfactants - therapeutic use ; Respiratory Distress Syndrome, Newborn - drug therapy ; Respiratory Distress Syndrome, Newborn - therapy ; Surfactants ; Treatment Outcome</subject><ispartof>JAMA network open, 2024-09, Vol.7 (9), p.e2435347</ispartof><rights>2024. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright 2024 Gallini F et al. .</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-a295t-a23149340af525a1dad1ede143e83e1015efc9abc9bce3b1500e35e8892d8d663</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,860,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39320892$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gallini, Francesca</creatorcontrib><creatorcontrib>De Rose, Domenico Umberto</creatorcontrib><creatorcontrib>Iuliano, Roberta</creatorcontrib><creatorcontrib>Romeo, Domenico Marco</creatorcontrib><creatorcontrib>Tana, Milena</creatorcontrib><creatorcontrib>Paladini, Angela</creatorcontrib><creatorcontrib>Fusco, Francesca Paola</creatorcontrib><creatorcontrib>Nobile, Stefano</creatorcontrib><creatorcontrib>Cota, Francesco</creatorcontrib><creatorcontrib>Tirone, Chiara</creatorcontrib><creatorcontrib>Aurilia, Claudia</creatorcontrib><creatorcontrib>Lio, Alessandra</creatorcontrib><creatorcontrib>Esposito, Alice</creatorcontrib><creatorcontrib>Costa, Simonetta</creatorcontrib><creatorcontrib>D'Andrea, Vito</creatorcontrib><creatorcontrib>Ventura, Maria Luisa</creatorcontrib><creatorcontrib>Carnielli, Virgilio</creatorcontrib><creatorcontrib>Dani, Carlo</creatorcontrib><creatorcontrib>Mosca, Fabio</creatorcontrib><creatorcontrib>Fumagalli, Monica</creatorcontrib><creatorcontrib>Scarpelli, Gianfranco</creatorcontrib><creatorcontrib>Giordano, Lucio</creatorcontrib><creatorcontrib>Fasolato, Valeria</creatorcontrib><creatorcontrib>Petrillo, Flavia</creatorcontrib><creatorcontrib>Betta, Pasqua</creatorcontrib><creatorcontrib>Solinas, Agostina</creatorcontrib><creatorcontrib>Gitto, Eloisa</creatorcontrib><creatorcontrib>Gargano, Giancarlo</creatorcontrib><creatorcontrib>Mescoli, Giovanna</creatorcontrib><creatorcontrib>Martinelli, Stefano</creatorcontrib><creatorcontrib>Di Fabio, Sandra</creatorcontrib><creatorcontrib>Bernardo, Italo</creatorcontrib><creatorcontrib>Tina, Lucia Gabriella</creatorcontrib><creatorcontrib>Staffler, Alex</creatorcontrib><creatorcontrib>Stasi, Ilaria</creatorcontrib><creatorcontrib>Mondello, Isabella</creatorcontrib><creatorcontrib>Scapillati, Eleonora</creatorcontrib><creatorcontrib>Vedovato, Stefania</creatorcontrib><creatorcontrib>Maffei, Gianfranco</creatorcontrib><creatorcontrib>Bove, Adriano</creatorcontrib><creatorcontrib>Vitaliti, Marcello</creatorcontrib><creatorcontrib>Terrin, Gianluca</creatorcontrib><creatorcontrib>Lago, Paola</creatorcontrib><creatorcontrib>Gizzi, Camilla</creatorcontrib><creatorcontrib>Strozzi, Chiara</creatorcontrib><creatorcontrib>Villani, Paolo Ernesto</creatorcontrib><creatorcontrib>Berardi, Alberto</creatorcontrib><creatorcontrib>Cacace, Caterina</creatorcontrib><creatorcontrib>Bracaglia, Giorgio</creatorcontrib><creatorcontrib>Pascucci, Eleonora</creatorcontrib><creatorcontrib>Cools, Filip</creatorcontrib><creatorcontrib>Pillow, Jane J</creatorcontrib><creatorcontrib>Polglase, Graeme</creatorcontrib><creatorcontrib>Pastorino, Roberta</creatorcontrib><creatorcontrib>van Kaam, Anton H</creatorcontrib><creatorcontrib>Mercuri, Eugenio</creatorcontrib><creatorcontrib>Orfeo, Luigi</creatorcontrib><creatorcontrib>Vento, Giovanni</creatorcontrib><creatorcontrib>Malguzzi, Silvia</creatorcontrib><creatorcontrib>Rigotti, Camilla</creatorcontrib><creatorcontrib>Cecchi, Alessandra</creatorcontrib><creatorcontrib>Nigro, Gabriella</creatorcontrib><creatorcontrib>Costabile, Carmine Deni</creatorcontrib><creatorcontrib>Roma, Enza</creatorcontrib><creatorcontrib>Sindico, Paola</creatorcontrib><creatorcontrib>Venafra, Rita</creatorcontrib><creatorcontrib>Mattia, Carmine</creatorcontrib><creatorcontrib>Conversano, Maria</creatorcontrib><creatorcontrib>Ballardini, Elisa</creatorcontrib><creatorcontrib>Manganaro, Alessandro</creatorcontrib><creatorcontrib>Balestri, Eleonora</creatorcontrib><creatorcontrib>Gallo, Claudio</creatorcontrib><creatorcontrib>Catenazzi, Piero</creatorcontrib><creatorcontrib>Astori, Maria Graziana</creatorcontrib><creatorcontrib>Maranella, Eugenia</creatorcontrib><creatorcontrib>Grassia, Carolina</creatorcontrib><creatorcontrib>Maiolo, Kim</creatorcontrib><creatorcontrib>Castellano, Danilo</creatorcontrib><creatorcontrib>Massenzi, Luca</creatorcontrib><creatorcontrib>Chiodin, Elisabetta</creatorcontrib><creatorcontrib>Gallina, Maria Rita</creatorcontrib><creatorcontrib>Consigli, Chiara</creatorcontrib><creatorcontrib>Sorrentino, Elena</creatorcontrib><creatorcontrib>Bonato, Silvia</creatorcontrib><creatorcontrib>Mancini, Monica</creatorcontrib><creatorcontrib>Perniola, Roberto</creatorcontrib><creatorcontrib>Giannuzzo, Silvia</creatorcontrib><creatorcontrib>Tranchina, Elisa</creatorcontrib><creatorcontrib>Cardilli, Viviana</creatorcontrib><creatorcontrib>Dito, Lucia</creatorcontrib><creatorcontrib>Regoli, Daniela</creatorcontrib><creatorcontrib>Tormena, Francesca</creatorcontrib><creatorcontrib>Battajon, Nadia</creatorcontrib><creatorcontrib>Arena, Roberta</creatorcontrib><creatorcontrib>Allais, Benedetta</creatorcontrib><creatorcontrib>Guidotti, Isotta</creatorcontrib><creatorcontrib>Roversi, Federica</creatorcontrib><creatorcontrib>Meli, Valerio</creatorcontrib><creatorcontrib>Tulino, Viviana</creatorcontrib><creatorcontrib>Casati, Alessandra</creatorcontrib><creatorcontrib>IN-REC-SUR-E Study Group</creatorcontrib><title>Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial</title><title>JAMA network open</title><addtitle>JAMA Netw Open</addtitle><description>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.</description><subject>Cerebral palsy</subject><subject>Child, Preschool</subject><subject>Clinical trials</subject><subject>Cognitive ability</subject><subject>Extubation</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>High-Frequency Ventilation - methods</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Extremely Premature</subject><subject>Infant, Newborn</subject><subject>Infections</subject><subject>Intensive care</subject><subject>Intensive Care Units, Neonatal - statistics &amp; numerical data</subject><subject>Italy</subject><subject>Male</subject><subject>Newborn babies</subject><subject>Online Only</subject><subject>Original Investigation</subject><subject>Pediatrics</subject><subject>Premature babies</subject><subject>Pulmonary Surfactants - administration &amp; dosage</subject><subject>Pulmonary Surfactants - therapeutic use</subject><subject>Respiratory Distress Syndrome, Newborn - drug therapy</subject><subject>Respiratory Distress Syndrome, Newborn - therapy</subject><subject>Surfactants</subject><subject>Treatment Outcome</subject><issn>2574-3805</issn><issn>2574-3805</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkU1vEzEQhi0EolXav4AsuHDZ4I91uu4FlagFpIii0h44WZPd2eLgtVPbS2lP_ek4_VLpxWN53nnHrx5C3nI25YzxDysYwGO-DPF3WKOfCibqqVSy3ntBtoXaqyvZMPXyyX2L7Ka0YowJxqWeqddkS2opWKPFNrlZjP6cnmAbR5sH9Jl-wj5EpD_G2EObobwcdIP1NuUI2QZPraeHf3PEAd0V_R4xYxzoNwweMqZ9KqqfCJEeBefCZXW2pqGnQE_Ad2Gw19jRuStuLTh6Gi24HfKqB5dw975OyNnR4en8S7U4_vx1frCoQGiVyyl5rWXNoFdCAe-g49ghryU2EjnjCvtWw7LVyxblkivGUCpsSsiu6WYzOSEf73zX43LAri1RIzizjnaAeGUCWPN_x9tf5jz8MZzXQm12T8j7e4cYLkZM2Qw2tehc4RHGZCRnuhZaqI303TPpKozRl3xFVey0KNiKav9O1caQUsT-8TecmQ1s8wy22cA2t7DL8JuneR5HH9DKfxZBrPs</recordid><startdate>20240903</startdate><enddate>20240903</enddate><creator>Gallini, Francesca</creator><creator>De Rose, Domenico Umberto</creator><creator>Iuliano, Roberta</creator><creator>Romeo, Domenico Marco</creator><creator>Tana, 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Gabriella</creator><creator>Staffler, Alex</creator><creator>Stasi, Ilaria</creator><creator>Mondello, Isabella</creator><creator>Scapillati, Eleonora</creator><creator>Vedovato, Stefania</creator><creator>Maffei, Gianfranco</creator><creator>Bove, Adriano</creator><creator>Vitaliti, Marcello</creator><creator>Terrin, Gianluca</creator><creator>Lago, Paola</creator><creator>Gizzi, Camilla</creator><creator>Strozzi, Chiara</creator><creator>Villani, Paolo Ernesto</creator><creator>Berardi, Alberto</creator><creator>Cacace, Caterina</creator><creator>Bracaglia, Giorgio</creator><creator>Pascucci, Eleonora</creator><creator>Cools, Filip</creator><creator>Pillow, Jane J</creator><creator>Polglase, Graeme</creator><creator>Pastorino, Roberta</creator><creator>van Kaam, Anton H</creator><creator>Mercuri, Eugenio</creator><creator>Orfeo, Luigi</creator><creator>Vento, Giovanni</creator><creator>Malguzzi, Silvia</creator><creator>Rigotti, Camilla</creator><creator>Cecchi, 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Nobile, Stefano ; Cota, Francesco ; Tirone, Chiara ; Aurilia, Claudia ; Lio, Alessandra ; Esposito, Alice ; Costa, Simonetta ; D'Andrea, Vito ; Ventura, Maria Luisa ; Carnielli, Virgilio ; Dani, Carlo ; Mosca, Fabio ; Fumagalli, Monica ; Scarpelli, Gianfranco ; Giordano, Lucio ; Fasolato, Valeria ; Petrillo, Flavia ; Betta, Pasqua ; Solinas, Agostina ; Gitto, Eloisa ; Gargano, Giancarlo ; Mescoli, Giovanna ; Martinelli, Stefano ; Di Fabio, Sandra ; Bernardo, Italo ; Tina, Lucia Gabriella ; Staffler, Alex ; Stasi, Ilaria ; Mondello, Isabella ; Scapillati, Eleonora ; Vedovato, Stefania ; Maffei, Gianfranco ; Bove, Adriano ; Vitaliti, Marcello ; Terrin, Gianluca ; Lago, Paola ; Gizzi, Camilla ; Strozzi, Chiara ; Villani, Paolo Ernesto ; Berardi, Alberto ; Cacace, Caterina ; Bracaglia, Giorgio ; Pascucci, Eleonora ; Cools, Filip ; Pillow, Jane J ; Polglase, Graeme ; Pastorino, Roberta ; van Kaam, Anton H ; Mercuri, Eugenio ; Orfeo, Luigi ; Vento, Giovanni ; Malguzzi, Silvia ; Rigotti, Camilla ; Cecchi, Alessandra ; Nigro, Gabriella ; Costabile, Carmine Deni ; Roma, Enza ; Sindico, Paola ; Venafra, Rita ; Mattia, Carmine ; Conversano, Maria ; Ballardini, Elisa ; Manganaro, Alessandro ; Balestri, Eleonora ; Gallo, Claudio ; Catenazzi, Piero ; Astori, Maria Graziana ; Maranella, Eugenia ; Grassia, Carolina ; Maiolo, Kim ; Castellano, Danilo ; Massenzi, Luca ; Chiodin, Elisabetta ; Gallina, Maria Rita ; Consigli, Chiara ; Sorrentino, Elena ; Bonato, Silvia ; Mancini, Monica ; Perniola, Roberto ; Giannuzzo, Silvia ; Tranchina, Elisa ; Cardilli, Viviana ; Dito, Lucia ; Regoli, Daniela ; Tormena, Francesca ; Battajon, Nadia ; Arena, Roberta ; Allais, Benedetta ; Guidotti, Isotta ; Roversi, Federica ; Meli, Valerio ; Tulino, Viviana ; Casati, 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Surfactants - administration &amp; dosage</topic><topic>Pulmonary Surfactants - therapeutic use</topic><topic>Respiratory Distress Syndrome, Newborn - drug therapy</topic><topic>Respiratory Distress Syndrome, Newborn - therapy</topic><topic>Surfactants</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gallini, Francesca</creatorcontrib><creatorcontrib>De Rose, Domenico Umberto</creatorcontrib><creatorcontrib>Iuliano, Roberta</creatorcontrib><creatorcontrib>Romeo, Domenico Marco</creatorcontrib><creatorcontrib>Tana, Milena</creatorcontrib><creatorcontrib>Paladini, Angela</creatorcontrib><creatorcontrib>Fusco, Francesca Paola</creatorcontrib><creatorcontrib>Nobile, Stefano</creatorcontrib><creatorcontrib>Cota, Francesco</creatorcontrib><creatorcontrib>Tirone, Chiara</creatorcontrib><creatorcontrib>Aurilia, Claudia</creatorcontrib><creatorcontrib>Lio, Alessandra</creatorcontrib><creatorcontrib>Esposito, 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Nadia</creatorcontrib><creatorcontrib>Arena, Roberta</creatorcontrib><creatorcontrib>Allais, Benedetta</creatorcontrib><creatorcontrib>Guidotti, Isotta</creatorcontrib><creatorcontrib>Roversi, Federica</creatorcontrib><creatorcontrib>Meli, Valerio</creatorcontrib><creatorcontrib>Tulino, Viviana</creatorcontrib><creatorcontrib>Casati, Alessandra</creatorcontrib><creatorcontrib>IN-REC-SUR-E Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>JAMA network open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gallini, Francesca</au><au>De Rose, Domenico Umberto</au><au>Iuliano, Roberta</au><au>Romeo, Domenico Marco</au><au>Tana, Milena</au><au>Paladini, Angela</au><au>Fusco, Francesca Paola</au><au>Nobile, Stefano</au><au>Cota, Francesco</au><au>Tirone, Chiara</au><au>Aurilia, Claudia</au><au>Lio, Alessandra</au><au>Esposito, Alice</au><au>Costa, Simonetta</au><au>D'Andrea, Vito</au><au>Ventura, Maria Luisa</au><au>Carnielli, Virgilio</au><au>Dani, Carlo</au><au>Mosca, Fabio</au><au>Fumagalli, Monica</au><au>Scarpelli, Gianfranco</au><au>Giordano, Lucio</au><au>Fasolato, Valeria</au><au>Petrillo, Flavia</au><au>Betta, Pasqua</au><au>Solinas, Agostina</au><au>Gitto, Eloisa</au><au>Gargano, Giancarlo</au><au>Mescoli, Giovanna</au><au>Martinelli, Stefano</au><au>Di Fabio, Sandra</au><au>Bernardo, Italo</au><au>Tina, Lucia Gabriella</au><au>Staffler, Alex</au><au>Stasi, Ilaria</au><au>Mondello, Isabella</au><au>Scapillati, Eleonora</au><au>Vedovato, Stefania</au><au>Maffei, Gianfranco</au><au>Bove, Adriano</au><au>Vitaliti, Marcello</au><au>Terrin, Gianluca</au><au>Lago, Paola</au><au>Gizzi, Camilla</au><au>Strozzi, Chiara</au><au>Villani, Paolo Ernesto</au><au>Berardi, Alberto</au><au>Cacace, Caterina</au><au>Bracaglia, Giorgio</au><au>Pascucci, Eleonora</au><au>Cools, Filip</au><au>Pillow, Jane J</au><au>Polglase, Graeme</au><au>Pastorino, Roberta</au><au>van Kaam, Anton H</au><au>Mercuri, Eugenio</au><au>Orfeo, Luigi</au><au>Vento, Giovanni</au><au>Malguzzi, Silvia</au><au>Rigotti, Camilla</au><au>Cecchi, Alessandra</au><au>Nigro, Gabriella</au><au>Costabile, Carmine Deni</au><au>Roma, Enza</au><au>Sindico, Paola</au><au>Venafra, Rita</au><au>Mattia, Carmine</au><au>Conversano, Maria</au><au>Ballardini, Elisa</au><au>Manganaro, Alessandro</au><au>Balestri, Eleonora</au><au>Gallo, Claudio</au><au>Catenazzi, Piero</au><au>Astori, Maria Graziana</au><au>Maranella, Eugenia</au><au>Grassia, Carolina</au><au>Maiolo, Kim</au><au>Castellano, Danilo</au><au>Massenzi, Luca</au><au>Chiodin, Elisabetta</au><au>Gallina, Maria Rita</au><au>Consigli, Chiara</au><au>Sorrentino, Elena</au><au>Bonato, Silvia</au><au>Mancini, Monica</au><au>Perniola, Roberto</au><au>Giannuzzo, Silvia</au><au>Tranchina, Elisa</au><au>Cardilli, Viviana</au><au>Dito, Lucia</au><au>Regoli, Daniela</au><au>Tormena, Francesca</au><au>Battajon, Nadia</au><au>Arena, Roberta</au><au>Allais, Benedetta</au><au>Guidotti, Isotta</au><au>Roversi, Federica</au><au>Meli, Valerio</au><au>Tulino, Viviana</au><au>Casati, Alessandra</au><aucorp>IN-REC-SUR-E Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial</atitle><jtitle>JAMA network open</jtitle><addtitle>JAMA Netw Open</addtitle><date>2024-09-03</date><risdate>2024</risdate><volume>7</volume><issue>9</issue><spage>e2435347</spage><pages>e2435347-</pages><issn>2574-3805</issn><eissn>2574-3805</eissn><abstract>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.</abstract><cop>United States</cop><pub>American Medical Association</pub><pmid>39320892</pmid><doi>10.1001/jamanetworkopen.2024.35347</doi><oa>free_for_read</oa></addata></record>
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subjects Cerebral palsy
Child, Preschool
Clinical trials
Cognitive ability
Extubation
Female
Follow-Up Studies
High-Frequency Ventilation - methods
Humans
Infant
Infant, Extremely Premature
Infant, Newborn
Infections
Intensive care
Intensive Care Units, Neonatal - statistics & numerical data
Italy
Male
Newborn babies
Online Only
Original Investigation
Pediatrics
Premature babies
Pulmonary Surfactants - administration & dosage
Pulmonary Surfactants - therapeutic use
Respiratory Distress Syndrome, Newborn - drug therapy
Respiratory Distress Syndrome, Newborn - therapy
Surfactants
Treatment Outcome
title Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial
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