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Background: Inodilators are routinely used in cardiovascular surgery with cardiopulmonary bypass (cPB). Information regarding safety and tolerability of the novel molecule, levosimendan (LeVO), in newborns is anecdotal; no pharmacokinetic data in this population are available. Methods: This was a phase I, randomized, and blinded study. Neonates undergoing surgical repair for congenital heart defects received stepwise dose increases of milrinone (MR; 0.5-1 μg/kg/min, n = 9) or LeVO (0.1-0.2 μg/kg/min, n = 11) as an i.v. continuous infusion, starting before cPB. Infants had continuous, time-locked, physiological, and near-infrared spectroscopy (NIRs) (cerebral and peripheral) recordings during the first 24 h, and at 48 and 96 h postsurgery. serial biochemistry and pharmacokinetic studies were performed. results: During the first 24 h postsurgery, patients showed time-related, group-independent increased cerebral tissue oxygenation and decreased diastolic blood pressure; in addition, group-dependent differences in heart rate and peripheral perfusion were found. early postsurgery, MR-treated infants showed lower ph, higher glycemia, and higher inotrope score. The groups differed in cerebral NIRs-derived variables from 24 to 96 h. study drug withdrawal at 96 h was more frequent with LeVO. LeVO intermediate metabolites were detected in plasma at day 14 after surgery. conclusion: LeVO is well tolerated in critically ill neonates. LeVO may have advantages over MR in terms of the dosing regimen.

Prematurity and BPD have an elevated cost, even for public health care systems. This cost will probably increase in the coming years if the incidence and survival of preterm babies keeps rising. The development of new therapies and preventive strategies to decrease the incidence of BPD and other morbidities associated with prematurity should be a priority. What is known: • Bronchopulmonary dysplasia (BPD) is a serious chronic lung disease related with premature birth. • BPD is an increasing disease due to the up-rise in the number of premature births. What is new: • The economic cost of preterm birth and BPD has never before been estimated in Spain nor published with European data. • Preterm babies with BPD and a good clinical outcome carry also an important economic and social burden.

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