From immature pharmacotherapy towards pharmacotherapy of the immature

Seminars in Fetal and Neonatal Medicine - Tập 27 - Trang 101327 - 2022
Karel Allegaert1,2,3, John N. van den Anker4,5,6
1Department of Development and Regeneration, Belgium
2Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
3Hospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands
4Division of Clinical Pharmacology, Department of Pediatrics, Children's National Hospital, Washington, DC, United States
5Division of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, University of Basel, Switzerland
6Intensive Care and Department of Pediatric Surgery, Erasmus Medical Center-Sophia Children’s Hospital, Rotterdam, The Netherlands

Tài liệu tham khảo

Ward, 2017, Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates, Pediatr Res, 81, 692, 10.1038/pr.2016.221 Van den Anker, 2021, Considerations for drug dosing in premature infants, J Clin Pharmacol, 61, S141 Mishra, 2021, Skincare practices in extremely premature infants: a survey of tertiary neonatal intensive care units from Australia and New Zealand, J Paediatr Child Health, 57, 1627, 10.1111/jpc.15578 Rysavy, 2021, An immature science: intensive care for infants born at ≤23 weeks of gestation, J Pediatr, 233, 16, 10.1016/j.jpeds.2021.03.006 van Donge, 2021, Characterizing dynamics of serum creatinine and creatinine clearance in extremely low birth weight neonates during the first 6 weeks of life, Pediatr Nephrol, 36, 649, 10.1007/s00467-020-04749-3 Masumoto, 2021, Hemodynamic support of the micropreemie: should hydrocortisone never be left out, Semin Fetal Neonatal Med, 26, 101222, 10.1016/j.siny.2021.101222 Allegaert, 2021, Dose-related adverse drug events in neonates: recognition and assessment, J Clin Pharmacol, 61, S152 Du, 2013, An algorithm to detect adverse drug reactions in the neonatal intensive care unit, J Clin Pharmacol, 53, 87, 10.1177/0091270011433327 Roberts, 2021, Prospective identification and causality evaluation of suspected adverse drug reactions in neonates, Br J Clin Pharmacol, 87, 1541, 10.1111/bcp.14485 Davis, 2020, Standardizing safety assessment and reporting for neonatal clinical trials, J Pediatr, 219, 243, 10.1016/j.jpeds.2019.09.060 Salaets, 2019, Development of a neonatal adverse event severity scale through a Delphi consensus approach, Arch Dis Child, 104, 1167, 10.1136/archdischild-2019-317399 Victor, 2011, Plasma aminotransferase concentrations in preterm infants, Arch Dis Child Fetal Neonatal Ed, 96, F144, 10.1136/adc.2008.152454 Jetton, 2012, Update on acute kidney injury in the neonate, Curr Opin Pediatr, 24, 191, 10.1097/MOP.0b013e32834f62d5 Allegaert, 2020, Renal precision medicine in neonates and acute kidney injury: how to convert a cloud of creatinine observations to support clinical decisions, Front Pediatr, 8, 366, 10.3389/fped.2020.00366 Allegaert, 2019, Research on medication use in the neonatal intensive care unit, Expet Rev Clin Pharmacol, 12, 343, 10.1080/17512433.2019.1580569 Stark, 2022, Medication use in the neonatal intensive care unit and changes from 2010 to 2018, J Pediatr, 240, 66, 10.1016/j.jpeds.2021.08.075 Hsieh, 2014, Medication use in the neonatal intensive care unit, Am J Perinatol, 31, 811, 10.1055/s-0033-1361933 Bell, 2022, Mortality, in-hospital morbidity, care practices, and 2-year outcomes for extremely preterm infants in the US, 2013-2018, JAMA, 327, 248, 10.1001/jama.2021.23580 * Database of neonatal research Network of Japan. http://plaza.umin.ac.jp/nrndata/indexe.htm. [Accessed January 2022]. Nakanishi, 2018, Persistent pulmonary hypertension of the newborn in extremely preterm infants: a Japanese cohort study, Arch Dis Child Fetal Neonatal Ed, 103, F554, 10.1136/archdischild-2017-313778 McGoldrick, 2020, Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth, Cochrane Database Syst Rev, 12, CD004454 Park, 2016, Antenatal corticosteroid therapy before 24 weeks of gestation: a systematic review and meta-analysis, Obstet Gynecol, 127, 715, 10.1097/AOG.0000000000001355 Rysavy, 2019, Discordance in antenatal corticosteroid use and resuscitation following extremely preterm birth, J Pediatr, 208, 156, 10.1016/j.jpeds.2018.12.063 Chawla, 2016, Association of neurodevelopmental outcomes and neonatal morbidities of extremely premature infants with differential exposure to antenatal steroids, JAMA Pediatr, 170, 1164, 10.1001/jamapediatrics.2016.1936 Baud, 2016, Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial, Lancet, 387, 1827, 10.1016/S0140-6736(16)00202-6 Baud, 2019, Two-year neurodevelopmental outcomes of extremely preterm infants treated with early hydrocortisone: treatment effect according to gestational age at birth, Arch Dis Child Fetal Neonatal, 104, F30, 10.1136/archdischild-2017-313756 Allegaert, 2015, Neonatal drug therapy: the first frontier of therapeutics for children, Clin Pharmacol Ther, 98, 288, 10.1002/cpt.166 Schrier, 2020, Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric Pharmacology, Eur J Pediatr, 179, 839, 10.1007/s00431-019-03556-9 Smits, 2021, Current knowledge, challenges and innovations in developmental pharmacology: a combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology white paper, Br J Clin Pharmacol Smits, 2019, Physiologically based pharmacokinetic (PBPK) modeling and simulation in neonatal drug development: how clinicians can contribute, Expet Opin Drug Metabol Toxicol, 15, 25, 10.1080/17425255.2019.1558205 Michelet, 2017, PBPK in preterm and term neonates: a review, Curr Pharmaceut Des, 23, 5943, 10.2174/1381612823666171009143840 Olafuyi, 2021, Physiologically based pharmacokinetic modelling of acetaminophen in preterm neonates-The impact of metabolising enzyme ontogeny and reduced cardiac output, Biopharm Drug Dispos, 42, 401, 10.1002/bdd.2301 Smits, 2020, A physiology-based pharmacokinetic framework to support drug development and dose precision during therapeutic hypothermia in neonates, Front Pharmacol, 11, 587, 10.3389/fphar.2020.00587 Adbuljalil, 2020, A preterm physiologically based pharmacokinetic model. Part I: physiological parameters and model building, Clin Pharmacokinet, 59, 485, 10.1007/s40262-019-00825-6 Abduljalil, 2020, Preterm physiologically based pharmacokinetic model. Part II: applications of the model to predict drug pharmacokinetics in the preterm population, Clin Pharmacokinet, 59, 501, 10.1007/s40262-019-00827-4 Claassen, 2015, Development of a physiologically-based pharmacokinetic model for preterm neonates: evaluation with in vivo data, Curr Pharmaceut Des, 21, 5688, 10.2174/1381612821666150901110533 Bouazza, 2021, Pharmacokinetics of intravenous paracetamol (acetaminophen) and ductus arteriosus closure after premature birth, Clin Pharmacol Ther, 1107, 1087, 10.1002/cpt.2380