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

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 a...

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Published in:	Current controlled trials in cardiovascular medicine Vol. 25; no. 1; pp. 433 - 18
Main Authors:	Vento, Giovanni, Paladini, Angela, 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
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 02-07-2024 BioMed Central BMC
Subjects:	Airway Extubation - adverse effects Bronchopulmonary Dysplasia - therapy Care and treatment Children & youth Childrens health Clinical trials Comparative analysis Congenital heart disease Continuous Positive Airway Pressure Dysplasia Female Gestational Age HFOV Hospitals Humans Infant, Newborn Infant, Premature Infants (Premature) INRECSURE Intubation, Intratracheal LISA Lung recruitment Multicenter Studies as Topic Neonatal care Neonatology Newborn babies Preterm infants Public health Pulmonary function tests Pulmonary Surfactants - administration & dosage Randomized Controlled Trials as Topic Respiratory distress syndrome Respiratory Distress Syndrome, Newborn - mortality Respiratory Distress Syndrome, Newborn - therapy Study Protocol Surface active agents Surfactant Time Factors Treatment Outcome Italy Melbourne Victoria Australia Australia United States > US Rome Italy China LISA INRECSURE HFOV Surfactant Lung recruitment Preterm infants
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Summary:	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. In this study, 382 infants born at 24 -27 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 to 25 weeks or 26 to 27 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). This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24 -27 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. ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	1745-6215 1745-6215
DOI:	10.1186/s13063-024-08240-4