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 Giovanni, Paladini AngelaORCID, Aurilia C., Ozdemir S. Alkan, Carnielli V. P., Cools F., Costa S., Cota F., Dani C., Davis P. G., Fattore S., Fè C., Finer N., Fusco F. P., Gizzi C., Herting E., Jian M., Lio A., Lista G., Mosca F., Nobile S., Perri A., Picone S., Pillow J. J., Polglase G., Pasciuto T., Pastorino R., Tana M., Tingay D., Tirone C., van Kaam A. H., Ventura M. L., Aceti A., Agosti M., Alighieri G., Ancora G., Angileri V., Ausanio G., Aversa S., Balestri E., Baraldi E., Barbini M. C., 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 M. F., Capasso L., Capozza M., Capretti M. G., 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 L. T., 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 V. A., Fatuzzo V., Favini F., Ferrarello M. P., Ferrari S., Nastro F. Fiori, Forcellini C. A., Fracchiolla A., Gabriele A., Galdo F., Gallini F., Gangemi A., Gargano G., Gazzolo D., Gentile M. P., 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 I. V., 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 M. G., Pasta E., Patti L., Paviotti G., Perniola R., Perotti G., Perrone S., Petrillo F., Piazza M. S., Piccirillo A., Pierro M., Piga E., Pingitore G. A., 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 F. M., 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 S. Semeria, 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 P. E., Viola S., Viola V., Vitaliti G., Vitaliti M., Wanker P., Yang Y., Zanetta S., Zannin E.
Abstract
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.
Funder
Chiesi Foundation Vygon Italia s.r.l.
Publisher
Springer Science and Business Media LLC
Reference30 articles.
1. Svedenkrans J, Stoecklin B, Jones JG, Doherty DA, Pillow JJ. Physiology and predictors of impaired gas exchange in infants with bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2019;200:471–80. 2. Brix N, Sellmer A, Jensen MS, Pedersen LV, Henriksen TB. Predictors for an unsuccessful Intubation-SURfactant-extubation procedure: a cohort study. BMC Pediatr. 2014;14:155–62. 3. Lakkundi A, Wright I, de Waal K. Transitional hemodynamics in preterm infants with a respiratory management strategy directed at avoidance of mechanical ventilation. Early Human Dev. 2014;90:409–12. 4. Dani C, Corsini I, Bertini G, Fontanelli G, Pratesi S, Rubaltelli F. The INSURE method in preterm infants of less than 30 weeks’ gestation. J Matern Fetal Neonatal Med. 2010;23:1024–9. 5. Cherif A, Hachani C, Khrouf N. Risk factors of the failure of surfactant treatment by transient intubation during nasal continuous positive airway pressure in preterm infants. Am J Perinatol. 2008;25:647–52.
|
|