Importance 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. Objective 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. Design, Setting, and Participants 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. Intervention Infants were randomly assigned (1:1) to IN-REC-SUR-E or IN-SUR-E and then followed up. Main Outcomes and Measures 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. Results 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. Conclusions and Relevance 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.
Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial / 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: JAMA NETWORK OPEN. - ISSN 2574-3805. - ELETTRONICO. - 7:(2024), pp. 0-0. [10.1001/jamanetworkopen.2024.35347]
Lung Recruitment Before Surfactant Administration in Extremely Preterm Neonates: 2-Year Follow-Up of a Randomized Clinical Trial
Dani, Carlo;
2024
Abstract
Importance 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. Objective 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. Design, Setting, and Participants 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. Intervention Infants were randomly assigned (1:1) to IN-REC-SUR-E or IN-SUR-E and then followed up. Main Outcomes and Measures 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. Results 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. Conclusions and Relevance 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.
I documenti in FLORE sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
