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

Author

Gallini F, De Rose DU, Iuliano R, Romeo DM, Tana M, Paladini A, Fusco FP, Nobile S, Cota F, Tirone C, Aurilia C, Lio A, Esposito A, Costa S, D'Andrea V, Ventura ML, Carnielli V, Dani C, Mosca F, Fumagalli M, Scarpelli G, Giordano L, Fasolato V, Petrillo F, Betta P, Solinas A, Gitto E, Gargano G, Mescoli G, Martinelli S, Di Fabio S, Bernardo I, Tina LG, Staffler A, Stasi I, Mondello I, Scapillati E, Vedovato S, Maffei G, Bove A, Vitaliti M, Terrin G, Lago P, Gizzi C, Strozzi C, Villani PE, Berardi A, Cacace C, Bracaglia G, Pascucci E, Cools F, Pillow JJ, Polglase G, Pastorino R, van Kaam AH, Mercuri E, Orfeo L, Vento G, Malguzzi S, Rigotti C, Cecchi A, Nigro G, Costabile CD, Roma E, Sindico P, Venafra R, Mattia C, Conversano M, Ballardini E, Manganaro A, Balestri E, Gallo C, Catenazzi P, Astori MG, Maranella E, Grassia C, Maiolo K, Castellano D, Massenzi L, Chiodin E, Gallina MR, Consigli C, Sorrentino E, Bonato S, Mancini M, Perniola R, Giannuzzo S, Tranchina E, Cardilli V, Dito L, Regoli D, Tormena F, Battajon N, Arena R, Allais B, Guidotti I, Roversi F, Meli V, Tulino V, and Casati A

Subjects
Humans, Male, Female, Infant, Newborn, Follow-Up Studies, High-Frequency Ventilation methods, Child, Preschool, Intensive Care Units, Neonatal statistics & numerical data, Treatment Outcome, Italy, Infant, Pulmonary Surfactants administration & dosage, Pulmonary Surfactants therapeutic use, Infant, Extremely Premature, Respiratory Distress Syndrome, Newborn therapy, Respiratory Distress Syndrome, Newborn drug therapy
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.

Published
2024
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2. Comparison of "IN-REC-SUR-E" and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial).

Author

Vento G, Paladini A, Aurilia C, Ozdemir SA, Carnielli VP, Cools F, Costa S, Cota F, Dani C, Davis PG, Fattore S, Fè C, Finer N, Fusco FP, Gizzi C, Herting E, Jian M, Lio A, Lista G, Mosca F, Nobile S, Perri A, Picone S, Pillow JJ, Polglase G, Pasciuto T, Pastorino R, Tana M, Tingay D, Tirone C, van Kaam AH, Ventura ML, Aceti A, Agosti M, Alighieri G, Ancora G, Angileri V, Ausanio G, Aversa S, Balestri E, Baraldi E, Barbini MC, Barone C, Beghini R, Bellan C, Berardi A, Bernardo I, Betta P, Binotti M, Bizzarri B, Borgarello G, Borgione S, Borrelli A, Bottino R, Bracaglia G, Bresesti I, Burattini I, Cacace C, Calzolari F, Campagnoli MF, Capasso L, Capozza M, Capretti MG, Caravetta J, Carbonara C, Cardilli V, Carta M, Castoldi F, Castronovo A, Cavalleri E, Cavigioli F, Cecchi S, Chierici V, Cimino C, Cocca F, Cocca C, Cogo P, Coma M, Comito V, Condò V, Consigli C, Conti R, Corradi M, Corsello G, Corvaglia LT, Costa A, Coscia A, Cresi F, Crispino F, D'Amico P, De Cosmo L, De Maio C, Del Campo G, Di Credico S, Di Fabio S, Di Nicola P, Di Paolo A, Di Valerio S, Distilo A, Duca V, Falcone A, Falsaperla R, Fasolato VA, Fatuzzo V, Favini F, Ferrarello MP, Ferrari S, Nastro FF, Forcellini CA, Fracchiolla A, Gabriele A, Galdo F, Gallini F, Gangemi A, Gargano G, Gazzolo D, Gentile MP, Ghirardello S, Giardina F, Giordano L, Gitto E, Giuffrè M, Grappone L, Grasso F, Greco I, Grison A, Guglielmino R, Guidotti I, Guzzo I, La Forgia N, La Placa S, La Torre G, Lago P, Lanciotti L, Lavizzari A, Leo F, Leonardi V, Lestingi D, Li J, Liberatore P, Lodin D, Lubrano R, Lucente M, Luciani S, Luvarà D, Maffei G, Maggio A, Maggio L, Maiolo K, Malaigia L, Mangili G, Manna A, Maranella E, Marciano A, Marcozzi P, Marletta M, Marseglia L, Martinelli D, Martinelli S, Massari S, Massenzi L, Matina F, Mattia L, Mescoli G, Migliore IV, Minghetti D, Mondello I, Montano S, Morandi G, Mores N, Morreale S, Morselli I, Motta M, Napolitano M, Nardo D, Nicolardi A, Nider S, Nigro G, Nuccio M, Orfeo L, Ottaviano C, Paganin P, Palamides S, Palatta S, Paolillo P, Pappalardo MG, Pasta E, Patti L, Paviotti G, Perniola R, Perotti G, Perrone S, Petrillo F, Piazza MS, Piccirillo A, Pierro M, Piga E, Pingitore GA, Pisu S, Pittini C, Pontiggia F, Pontrelli G, Primavera A, Proto A, Quartulli L, Raimondi F, Ramenghi L, Rapsomaniki M, Ricotti A, Rigotti C, Rinaldi M, Risso FM, Roma E, Romanini E, Romano V, Rosati E, Rosella V, Rulli I, Salvo V, Sanfilippo C, Sannia A, Saporito A, Sauna A, Scapillati E, Schettini F, Scorrano A, Mantelli SS, Sepporta V, Sindico P, Solinas A, Sorrentino E, Spaggiari E, Staffler A, Stella M, Termini D, Terrin G, Testa A, Tina G, Tirantello M, Tomasini B, Tormena F, Travan L, Trevisanuto D, Tuling G, Tulino V, Valenzano L, Vedovato S, Vendramin S, Villani PE, Viola S, Viola V, Vitaliti G, Vitaliti M, Wanker P, Yang Y, Zanetta S, and Zannin E

Subjects
Female, Humans, Infant, Newborn, Airway Extubation adverse effects, Bronchopulmonary Dysplasia therapy, Continuous Positive Airway Pressure, Gestational Age, Intubation, Intratracheal, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome, Infant, Premature, Pulmonary Surfactants administration & dosage, Respiratory Distress Syndrome, Newborn therapy, Respiratory Distress Syndrome, Newborn mortality
Abstract

Background: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration., Methods: In this study, 382 infants born at 24 +0 -27 +6  weeks' gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks' postmenstrual age. The secondary outcomes are BPD at 36 weeks' postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24 +0 to 25 +6  weeks or 26 +0 to 27 +6  weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR)., Discussion: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24 +0 -27 +6  weeks' gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks' postmenstrual age of life., Trial Registration: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023., (© 2024. The Author(s).)

Published
2024
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