Abstract

No aerosol system on the market is perfectly suited for aerosol therapy in infants. The RESPIRE project aims to answer this need by developing an innovative piezoelectric microperforated vibrating membrane nebulizer, the Baby Nimbus™; efficient, fast, portable and silent. Consisting of three complementary partners, the project was divided into three phases: technology development by the company Télémaq (Sophia Antipolis), in vitro and in vivo test performed on baboons by Inserm U618 (Tours), clinical trials in infants led by AP–HM (Marseille). Studies conducted by Inserm U618 and AP–HM focused on the influence of particle size on lung deposition in baboons and the clinical score in infants. Three devices of different droplet sizes were compared in the in vivo study, the Pari LC Sprint SP® (Pari, Germany, MMAD 4.5μm – flow 0.18mL/min), the E-Flow Rapid® (Pari, Germany, MMAD 4.8μm – flow 0.35mL/min) and Baby Nimbus™ (Télémaq, France). Four versions of Baby Nimbus™ were needed to achieve the MMAD of 2.4μm and flowrate of 0.4mL/min (Spraytec®, Malvern, England). Preliminary in vivo results show that the amount of the initial charge deposited in the lungs is 0.9% for the Pari LC Sprint SP®, 1.2% for E-Flow Rapid® and 2.2% for the Baby Nimbus™. Additional in vivo tests and clinical trials are under way to rule definitively on the efficiency provided by the Baby Nimbus™.

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