New medical device to deliver exogenous surfactant in preterm infants with neonatal respiratory distress syndrome: efficacy, safety and practicality. – EndoSurf

Lung immaturity at birth in preterm newborns (respiratory distress syndrome or RDS) requires the exogenous surfactant administration shortly after birth. Current surfactant administration techniques, although described as "less" invasive (Less Invasive Surfactant Administration or LISA), still require the use of laryngoscopy which remains a painful and complex procedure to learn. Sedation-analgesia represents a challenge for these patients, with the balance between the need to prevent or reduce the pain generated by laryngoscopy and the need to maintain efficient spontaneous breathing.
In this project, we propose the development and validation of a new medical device based on endoscopy and atomization for the administration of exogenous surfactant in preterm neonates with RDS. The objectives of the device are to i) decrease pain and discomfort and therefore the need for analgesia, ii) improve clinical tolerance and efficiency of surfactant administration (endoscopy and atomization of surfactant), and iii) have a better learning curve than LISA.
The development and validation of the efficacy and safety of the EndoSurf device is based on a multidisciplinary collaboration. The different steps of the project include i) the validation of the atomization process with the characterization of the atomized particles, the physicochemical properties of the atomized surfactant and the study of surfactant distribution within the lung in an ex-vivo model, ii) the study of the surfactant distribution and efficacy on an animal model of RDS (comparison with the LISA method), iii) the development of the prototype for industrialization and certification for clinical use, iv) the evaluation of the learning curve in medical simulation laboratory and v) a pilot clinical study on 20 preterm infants with RDS (comparison with a historical LISA cohort).