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Randomized Controlled Trial
. 2024 Sep 3;7(9):e2435347.
doi: 10.1001/jamanetworkopen.2024.35347.

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

Francesca Gallini  1   2   3 , Domenico Umberto De Rose  4 , Roberta Iuliano  1 , Domenico Marco Romeo  5 , Milena Tana  1 , Angela Paladini  1 , Francesca Paola Fusco  1 , Stefano Nobile  1 , Francesco Cota  1 , Chiara Tirone  1 , Claudia Aurilia  1 , Alessandra Lio  1 , Alice Esposito  1 , Simonetta Costa  1 , Vito D'Andrea  1 , Maria Luisa Ventura  6 , Virgilio Carnielli  7 , Carlo Dani  8 , Fabio Mosca  9 , Monica Fumagalli  9 , Gianfranco Scarpelli  10 , Lucio Giordano  11 , Valeria Fasolato  12 , Flavia Petrillo  13 , Pasqua Betta  14 , Agostina Solinas  15 , Eloisa Gitto  16 , Giancarlo Gargano  17 , Giovanna Mescoli  18 , Stefano Martinelli  19 , Sandra Di Fabio  20 , Italo Bernardo  21 , Lucia Gabriella Tina  22 , Alex Staffler  23 , Ilaria Stasi  24 , Isabella Mondello  25 , Eleonora Scapillati  26 , Stefania Vedovato  27 , Gianfranco Maffei  28 , Adriano Bove  29 , Marcello Vitaliti  30 , Gianluca Terrin  31 , Paola Lago  32 , Camilla Gizzi  33 , Chiara Strozzi  34 , Paolo Ernesto Villani  35 , Alberto Berardi  36 , Caterina Cacace  37 , Giorgio Bracaglia  38 , Eleonora Pascucci  39 , Filip Cools  40 , Jane J Pillow  41 , Graeme Polglase  42 , Roberta Pastorino  39   43 , Anton H van Kaam  44 , Eugenio Mercuri  5 , Luigi Orfeo  3 , Giovanni Vento  1   2 ; IN-REC-SUR-E Study Group; Silvia Malguzzi  6 , Camilla Rigotti  6 , Alessandra Cecchi  8 , Gabriella Nigro  10 , Carmine Deni Costabile  10 , Enza Roma  11 , Paola Sindico  12 , Rita Venafra  13 , Carmine Mattia  14 , Maria Conversano  14 , Elisa Ballardini  15 , Alessandro Manganaro  16 , Eleonora Balestri  17 , Claudio Gallo  17 , Piero Catenazzi  18 , Maria Graziana Astori  19 , Eugenia Maranella  20 , Carolina Grassia  21 , Kim Maiolo  22 , Danilo Castellano  22 , Luca Massenzi  23 , Elisabetta Chiodin  23 , Maria Rita Gallina  24 , Chiara Consigli  26 , Elena Sorrentino  26 , Silvia Bonato  27 , Monica Mancini  28 , Roberto Perniola  29 , Silvia Giannuzzo  29 , Elisa Tranchina  30 , Viviana Cardilli  31 , Lucia Dito  31 , Daniela Regoli  31 , Francesca Tormena  32 , Nadia Battajon  32 , Roberta Arena  3 , Benedetta Allais  35 , Isotta Guidotti  36 , Federica Roversi  36 , Valerio Meli  37 , Viviana Tulino  37 , Alessandra Casati  38
Affiliations
Randomized Controlled Trial

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

Francesca Gallini et al. JAMA Netw Open. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Pillow reported receiving grants from the Australian National Health and Medical Research Council during the conduct of the study and personal fees from Draeger Medical outside the submitted work. Dr van Kaam reported receiving grants and personal fees from Chiesi Pharmaceuticals outside the submitted work. No other disclosures were reported.

Figures

Figure.
Figure.. Flowchart of Randomization, Enrollment, and Follow-Up
See this image and copyright information in PMC

References

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