Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial

Biban, Paolo; Conti, Giorgio; Wolfler, Andrea; Carlassara, Silvia; Gitto, Eloisa; Rulli, Immacolata; Moscatelli, Andrea; Micalizzi, Camilla; Savron, Fabio; Sagredini, Raffaella; Genoni, Giulia; Binotti, Marco; Caramelli, Fabio; Fae, Monica; Pettenazzo, Andrea; Stritoni, Valentina; D'Amato, Luigia; Marinosci, Geremia Zito; Calderini, Edoardo; Catenacci, Stefano Scalia; Berardi, Alberto; Torcetta, Francesco; Bonanomi, Ezio; Bonacina, Daniele; Ivani, Giorgio; Santuz, Pierantonio

doi:10.1136/bmjopen-2020-038780

Cited by 2 publications

(1 citation statement)

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“…Only recently, a multicenter study led to definition of sharing criteria to administer surfactant in PARDS as compassionate therapy [ 98 ]. Currently ongoing explanatory trials recruit homogeneous populations of infants with bronchiolitis-induced PARDS [ 60 , 99 ]. These are examples of a correct step on the drug development pathway for a particular subgroup of patients.…”

Section: Discussionmentioning

confidence: 99%

Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps

et al. 2021

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Pediatric (PARDS) and neonatal (NARDS) acute respiratory distress syndrome have different age-specific characteristics and definitions. Trials on surfactant for ARDS in children and neonates have been performed well before the PARDS and NARDS definitions and yielded conflicting results. This is mainly due to heterogeneity in study design reflecting historic lack of pathobiology knowledge. We reviewed the available clinical and preclinical data to create an expert consensus aiming to inform future research steps and advance the knowledge in this area. Eight trials investigated the use of surfactant for ARDS in children and ten in neonates, respectively. There were improvements in oxygenation (7/8 trials in children, 7/10 in neonates) and mortality (3/8 trials in children, 1/10 in neonates) improved. Trials were heterogeneous for patients’ characteristics, surfactant type and administration strategy. Key pathobiological concepts were missed in study design. Consensus with strong agreement was reached on four statements: There are sufficient preclinical and clinical data to support targeted research on surfactant therapies for PARDS and NARDS. Studies should be performed according to the currently available definitions and considering recent pathobiology knowledge. PARDS and NARDS should be considered as syndromes and should be pre-clinically studied according to key characteristics, such as direct or indirect (primary or secondary) nature, clinical severity, infectious or non-infectious origin or patients’ age. Explanatory should be preferred over pragmatic design for future trials on PARDS and NARDS. Different clinical outcomes need to be chosen for PARDS and NARDS, according to the trial phase and design, trigger type, severity class and/or surfactant treatment policy. We advocate for further well-designed preclinical and clinical studies to investigate the use of surfactant for PARDS and NARDS following these principles.

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Section: Discussionmentioning

confidence: 99%

Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps

et al. 2021

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Pulmonary Surfactant: A Unique Biomaterial with Life-saving Therapeutic Applications

Pioselli

Salomone

Mazzola

et al. 2022

CMC

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: Pulmonary surfactant is a complex lipoprotein mixture secreted into the alveolar lumen by type 2 pneumocytes, which is composed by tens of different lipids (approximately 90% of its entire mass) and surfactant proteins (approximately 10% of the mass). It is crucially involved in maintaining lung homeostasis by reducing the values of alveolar liquid surface tension close to zero at end-expiration, thereby avoiding the alveolar collapse, and assembling a chemical and physical barrier against inhaled pathogens. A deficient amount of surfactant or its functional inactivation is directly linked to a wide range of lung pathologies, including the neonatal respiratory distress syndrome. This paper reviews the main biophysical concepts of surfactant activity and its inactivation mechanisms, and describes the past, present and future roles of surfactant replacement therapy, focusing on the exogenous surfactant preparations marketed worldwide and new formulations under development. The closing section describes the pulmonary surfactant in the context of drug delivery. Thanks to its peculiar composition, biocompatibility, and alveolar spreading capability, the surfactant may work not only as a shuttle to the branched anatomy of the lung for other drugs but also as a modulator for their release, opening to innovative therapeutic avenues for the treatment of several respiratory diseases.

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Efficacy and safety of exogenous surfactant therapy in patients under 12 months of age invasively ventilated for severe bronchiolitis (SURFABRON): protocol for a multicentre, randomised, double-blind, controlled, non-profit trial

Cited by 2 publications

References 26 publications

Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps

Surfactant therapies for pediatric and neonatal ARDS: ESPNIC expert consensus opinion for future research steps

Pulmonary Surfactant: A Unique Biomaterial with Life-saving Therapeutic Applications

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