Advanced Research in Neonatal Pharmacology

Dear Colleagues,

Newborns are not little children, and preterms are not just little newborns. In utero, ontogeny is disrupted by preterm birth and postnatal interventions, including exposure to hyperoxia, with potentially significant changes in organ perfusion. Nutritional problems may also affect organ and system development. Both "maturational" (organ and system development) and "non maturational determinants", such as comorbidities, treatments, and extracorporeal circuits (ECMO, CPB, and CRRT) contribute to substantial inter-individual variability in drug exposure and effects (including side effects). Maturational aspects involve all ADME processes (absorption, distribution, metabolism, and excretion). The glomerular filtration rate in neonates is based on birth weight and postnatal age, with a 2-4 fold increase in the first weeks of life. The disposition of a drug depends on protein binding capacity and body composition, the proportion of body water impacts on distribution volume of hydrophilic drugs. Treatment modalities may further modulate all these maturational physiological changes (e.g., whole body cooling, extracorporeal membrane oxygenation (ECMO), or pharmacotherapy) or underlying pathological processes (e.g., perinatal asphyxia, cardiopathy, sepsis, renal failure, patent ductus arteriosus). To optimize treatment efficacy and reduce drug toxicity, drug dosing in neonates should be based on integrated knowledge concerning the disease to be treated, the physiological characteristics of the neonate, and the pharmacokinetics (PK) and pharmacodynamics (PD) of a given drug, but PK studies on such population are scarce due to the difficulty in blood sampling. As a result, more than 90% of drugs routinely prescribed, including antibiotics, the most used drugs in neonates, are used in an off-label manner. Off-label use of drugs can result in unpredictable responses, secondary to either unexpected toxicity or lack of efficacy.

With this Biomedicines special issue, we aim to increase caregivers' awareness of the PK/PD aspects of drugs used in newborns and preterms, focusing on the opportunity to improve our knowledge using micro-sampling strategies. We will also pay attention to new data exploring maternal drugs' impact on the fetus and newborn by placenta and milk transport. We hope that this focus will facilitate the translation to precision medicine also in this special population of patients.

Dr. Giacomo Cavallaro
Dr. Genny Raffaeli
Dr. Felipe Garrido Martinez de Salazar
Dr. Nunzia Decembrino
Guest Editors

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• newborn diseases
• extracorporeal circuits
• neonatal dialysis
• neonatal analgosedation
• antimicrobial therapy
• therapeutic drug monitoring
• neonatal pharmacokinetic
• neonatal pharmacodynamic
• physiologically based pharmacokinetic (PBPK)
• neuroprotection