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

Abstract

Pediatric (PARDS) and neonatal (NARDS) acute respiratory distress syndrome have diferent age-specifc characteristics and defnitions. Trials on surfactant for ARDS in children and neonates have been performed well before the PARDS and NARDS defnitions and yielded conficting results. This is mainly due to heterogeneity in study design refecting 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 pathobiologi cal concepts were missed in study design. Consensus with strong agreement was reached on four statements: 1. Tere are sufcient preclinical and clinical data to support targeted research on surfactant therapies for PARDS and NARDS. Studies should be performed according to the currently available defnitions and considering recent pathobiology knowledge. 2. 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 noninfectious origin or patients’ age. 3. Explanatory should be preferred over pragmatic design for future trials on PARDS and NARDS. 4. Diferent 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