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The Role of the Pediatric Intensivist in the Coronavirus Disease 2019 Pandemic

928 www.pccmjournal.org October 2020 • Volume 21 • Number 10 response in premature infants with mild-to-moderate respiratory distress. In this regard, we agree with the comment by Madney et al… Click to show full abstract

928 www.pccmjournal.org October 2020 • Volume 21 • Number 10 response in premature infants with mild-to-moderate respiratory distress. In this regard, we agree with the comment by Madney et al (1) that the experimental period of 3 hours may be considered too short to investigate the full treatment response to a single dose and the possible need for repeat dosing. Indeed, after achieving our objective of identifying an appropriate dose of surfactant nebulization for the treatment of respiratory distress in our preclinical setting and demonstrating the safety of the technique using an e-Flow nebulizer (2), we undertook a long-term study to evaluate the efficacy of this technique over the critical period of 72 hours after surfactant administration (7). Our results confirm that the nebulization of 400 mg/kg of poractant alfa is effective in our animal model, given the 50% lower risk of respiratory failure (requiring intubation and mechanical ventilation) in the first 72 hours after surfactant administration treatment than nCPAP alone. Unfortunately, we did not test the repeat dosing option in this study setting. Finally, the authors raise an important question regarding the translation of the results obtained in our preclinical study to clinical practice. It is known that to better understand the pathophysiology of neonatal RDS and verify novel treatment approaches, RDS animal models have been extensively used for many years, and we would like to argue are still very much needed today. Nonetheless, while it is true that animal models provide a valuable bridge between laboratory research and the clinic, we agree, of course, that translating our results (and indeed the results from any preclinical experimental model) to human infants requires caution. Of note, a clinical trial to investigate the safety, tolerability, and efficacy of nebulized poractant alfa has been recently closed European Union Drug Regulating Authorities Clinical Trials Database Number: 23016-004547-36. More details on the outcomes of this clinical trial, and perhaps other future studies in the field, will be needed to understand the risk-benefit profile for this therapeutic option and, in turn, the potential role of surfactant nebulization in premature infants with RDS. Drs. Rey-Santano’s, Mielgo’s, and Gomez-Solaetxe’s institution received funding from Chiesi Farmaceutici and Carlos III Health Institute (PI14/00024), and they disclosed off-label product use of vibrating-membrane nebulizer (eFlow-Neos). Dr. Salomone disclosed off-label product use of aerosolized poractant alfa. Drs. Salomone and Bianco received funding from Chiesi Farmaceutici.

Keywords: role; pediatric intensivist; intensivist coronavirus; treatment; poractant alfa; role pediatric

Journal Title: Pediatric Critical Care Medicine
Year Published: 2020

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