{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T14:55:16Z","timestamp":1781535316415,"version":"3.54.5"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2021,2,21]],"date-time":"2021-02-21T00:00:00Z","timestamp":1613865600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2021,2,21]],"date-time":"2021-02-21T00:00:00Z","timestamp":1613865600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100010663","name":"H2020 European Research Council","doi-asserted-by":"publisher","award":["call H2020-PHC-2015-two-stage, grant  667224"],"award-info":[{"award-number":["call H2020-PHC-2015-two-stage, grant  667224"]}],"id":[{"id":"10.13039\/100010663","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Pharmacokinet"],"published-print":{"date-parts":[[2021,7]]},"DOI":"10.1007\/s40262-021-00991-6","type":"journal-article","created":{"date-parts":[[2021,2,21]],"date-time":"2021-02-21T05:37:00Z","timestamp":1613885820000},"page":"897-906","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Glomerular Filtration Rate in Asphyxiated Neonates Under Therapeutic Whole-Body Hypothermia, Quantified by Mannitol Clearance"],"prefix":"10.1007","volume":"60","clinical-trial-number":[{"clinical-trial-number":"nct03162653","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Neel","family":"Deferm","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim V.","family":"Annink","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruben","family":"Faelens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schroth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian A.","family":"Maiwald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Loubna el","family":"Bakkali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"van Bel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manon J. N. L.","family":"Benders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirjam M.","family":"van Weissenbruch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Hagen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Smits","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pieter","family":"Annaert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel R.","family":"Franz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9921-5105","authenticated-orcid":false,"given":"Karel","family":"Allegaert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ALBINO Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel R.","family":"Franz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mario","family":"R\u00fcdiger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian F.","family":"Poets","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manon","family":"Benders","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"van Bel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karel","family":"Allegaert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunnar","family":"Naulaers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Bassler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrin","family":"Klebermass-Schrehof","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximo","family":"Vento","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hercilia","family":"Guimaraes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Stiris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabella","family":"Mauro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjo","family":"Mets\u00e4ranta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sampsa","family":"Vanhatalo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Mazela","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tuuli","family":"Metsvaht","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yannique","family":"Jacobs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,2,21]]},"reference":[{"key":"991_CR1","doi-asserted-by":"publisher","first-page":"587","DOI":"10.3389\/fphar.2020.00587","volume":"11","author":"A Smits","year":"2020","unstructured":"Smits A, Annaert P, Van Cruchten S, Allegaert K. A physiology-based pharmacokinetic framework to support drug development and dose precision during therapeutic hypothermia in neonates. Front Pharmacol. 2020;11:587. https:\/\/doi.org\/10.3389\/fphar.2020.00587.","journal-title":"Front Pharmacol."},{"key":"991_CR2","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1186\/1471-2431-8-17","volume":"8","author":"D Azzopardi","year":"2008","unstructured":"Azzopardi D, Brocklehurst P, Edwards D, Halliday H, Levene M, Thoresen M, TOBY Study Group, et al. The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: a randomised controlled trial. BMC Pediatr. 2008;8:17. https:\/\/doi.org\/10.1186\/1471-2431-8-17.","journal-title":"BMC Pediatr."},{"key":"991_CR3","doi-asserted-by":"publisher","first-page":"366","DOI":"10.3389\/fped.2020.00366","volume":"8","author":"K Allegaert","year":"2020","unstructured":"Allegaert K, Smits A, van Donge T, van den Anker J, Sarafidis K, Levtchenko E, et al. Renal precision medicine in neonates and acute kidney injury: how to convert a cloud of creatinine observations to support clinical decisions. Front Pediatr. 2020;8:366. https:\/\/doi.org\/10.3389\/fped.2020.00366.","journal-title":"Front Pediatr."},{"key":"991_CR4","doi-asserted-by":"publisher","first-page":"129","DOI":"10.1179\/146532811X12925735813922","volume":"31","author":"S Kaur","year":"2011","unstructured":"Kaur S, Jain S, Saha A, Chawla D, Parmar VR, Basu S, et al. Evaluation of glomerular and tubular renal function in neonates with birth asphyxia. Ann Trop Paediatr. 2011;31:129\u201334. https:\/\/doi.org\/10.1179\/146532811X12925735813922.","journal-title":"Ann Trop Paediatr."},{"issue":"725\u201329","key":"991_CR5","doi-asserted-by":"publisher","first-page":"e1","DOI":"10.1016\/j.jpeds.2012.10.002","volume":"162","author":"DT Selewski","year":"2013","unstructured":"Selewski DT, Jordan BK, Askenazi DJ, Dechert RE, Sarkar S. Acute kidney injury in asphyxiated newborns treated with therapeutic hypothermia. J Pediatr. 2013;162(725\u201329):e1. https:\/\/doi.org\/10.1016\/j.jpeds.2012.10.002.","journal-title":"J Pediatr."},{"key":"991_CR6","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1007\/s00467-018-4068-2","volume":"34","author":"MJ Kirkley","year":"2019","unstructured":"Kirkley MJ, Boohaker L, Griffin R, Soranno DE, Gien J, Askenazi D, Neonatal Kidney Collaborative (NKC), et al. Acute kidney injury in neonatal encephalopathy: an evaluation of the AWAKEN database. Pediatr Nephrol. 2019;34:169\u201376. https:\/\/doi.org\/10.1007\/s00467-018-4068-2.","journal-title":"Pediatr Nephrol."},{"key":"991_CR7","doi-asserted-by":"publisher","first-page":"15682","DOI":"10.1038\/s41598-020-72717-w","volume":"10","author":"TYD Mok","year":"2020","unstructured":"Mok TYD, Tseng M-H, Lee J-C, Chou Y-C, Lien R, Lai M-Y, et al. A retrospective study on the incidence of acute kidney injury and its early prediction using troponin-I in cooled asphyxiated neonates. Sci Rep. 2020;10:15682. https:\/\/doi.org\/10.1038\/s41598-020-72717-w.","journal-title":"Sci Rep."},{"key":"991_CR8","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1111\/cpf.12374","volume":"38","author":"K Kiss","year":"2018","unstructured":"Kiss K, Moln\u00e1r M, S\u00f6ndergaard S, Moln\u00e1r G, Ricksten S-E. Mannitol clearance for the determination of glomerular filtration rate-a validation against clearance of 51 Cr-EDTA. Clin Physiol Funct Imaging. 2018;38:10\u20136. https:\/\/doi.org\/10.1111\/cpf.12374.","journal-title":"Clin Physiol Funct Imaging."},{"key":"991_CR9","doi-asserted-by":"publisher","first-page":"262","DOI":"10.5863\/1551-6776-19.4.262","volume":"19","author":"H Lu","year":"2014","unstructured":"Lu H, Rosenbaum S. Developmental pharmacokinetics in pediatric populations. J Pediatr Pharmacol Ther. 2014;19:262\u201376. https:\/\/doi.org\/10.5863\/1551-6776-19.4.262.","journal-title":"J Pediatr Pharmacol Ther."},{"key":"991_CR10","doi-asserted-by":"publisher","first-page":"E3","DOI":"10.1208\/ps020103","volume":"2","author":"WL Hayton","year":"2000","unstructured":"Hayton WL. Maturation and growth of renal function: dosing renally cleared drugs in children. AAPS PharmSci. 2000;2:E3. https:\/\/doi.org\/10.1208\/ps020103.","journal-title":"AAPS PharmSci."},{"key":"991_CR11","doi-asserted-by":"publisher","first-page":"1144","DOI":"10.1172\/JCI102149","volume":"28","author":"MI Rubin","year":"1949","unstructured":"Rubin MI, Bruck E, Rapoport M. Maturation of renal function in childhood; clearance studies. J Clin Invest. 1949;28:1144\u201362.","journal-title":"J Clin Invest."},{"key":"991_CR12","doi-asserted-by":"publisher","first-page":"210","DOI":"10.1186\/s12887-019-1566-8","volume":"19","author":"CA Maiwald","year":"2019","unstructured":"Maiwald CA, Annink KV, R\u00fcdiger M, Benders MJNL, van Bel F, Allegaert K, ALBINO Study Group, et al. Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III). BMC Pediatr. 2019;19:210. https:\/\/doi.org\/10.1186\/s12887-019-1566-8.","journal-title":"BMC Pediatr."},{"issue":"Suppl. 1","key":"991_CR13","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1007\/s00228-009-0782-9","volume":"67","author":"RFW De Cock","year":"2011","unstructured":"De Cock RFW, Piana C, Krekels EHJ, Danhof M, Allegaert K, Knibbe CAJ. The role of population PK-PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67(Suppl. 1):5\u201316. https:\/\/doi.org\/10.1007\/s00228-009-0782-9.","journal-title":"Eur J Clin Pharmacol."},{"key":"991_CR14","doi-asserted-by":"publisher","first-page":"67","DOI":"10.1007\/s00467-008-0997-5","volume":"24","author":"MM Rhodin","year":"2009","unstructured":"Rhodin MM, Anderson BJ, Peters AM, Coulthard MG, Wilkins B, Cole M, et al. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009;24:67\u201376. https:\/\/doi.org\/10.1007\/s00467-008-0997-5.","journal-title":"Pediatr Nephrol."},{"key":"991_CR15","doi-asserted-by":"publisher","first-page":"1463","DOI":"10.1023\/A:1011970125687","volume":"15","author":"EN Jonsson","year":"1998","unstructured":"Jonsson EN, Karlsson MO. Automated covariate model building within NONMEM. Pharm Res. 1998;15:1463\u20138.","journal-title":"Pharm Res."},{"key":"991_CR16","doi-asserted-by":"publisher","first-page":"1098","DOI":"10.1002\/cpt.1917","volume":"108","author":"LMA Favi\u00e9","year":"2020","unstructured":"Favi\u00e9 LMA, de Haan TR, Bijleveld YA, Rademaker CMA, Egberts TCG, Nuytemans DHGM, et al. Prediction of drug exposure in critically ill encephalopathic neonates treated with therapeutic hypothermia based on a pooled population pharmacokinetic analysis of seven drugs and five metabolites. Clin Pharmacol Ther. 2020;108:1098\u2013106. https:\/\/doi.org\/10.1002\/cpt.1917.","journal-title":"Clin Pharmacol Ther."},{"key":"991_CR17","doi-asserted-by":"publisher","first-page":"e01282","DOI":"10.1128\/AAC.01282-17","volume":"61","author":"S Cristea","year":"2017","unstructured":"Cristea S, Smits A, Kulo A, Knibbe CAJ, van Weissenbruch M, Krekels EHJ, et al. Amikacin pharmacokinetics to optimize dosing in neonates with perinatal asphyxia treated with hypothermia. Antimicrob Agents Chemother. 2017;61:e01282-e1317. https:\/\/doi.org\/10.1128\/AAC.01282-17.","journal-title":"Antimicrob Agents Chemother."},{"key":"991_CR18","doi-asserted-by":"publisher","first-page":"105","DOI":"10.2165\/11595640-000000000-00000","volume":"51","author":"RFW De Cock","year":"2012","unstructured":"De Cock RFW, Allegaert K, Schreuder MF, Sherwin CMT, de Hoog M, van den Anker JN, et al. Maturation of the glomerular filtration rate in neonates, as reflected by amikacin clearance. Clin Pharmacokinet. 2012;51:105\u201317. https:\/\/doi.org\/10.2165\/11595640-000000000-00000.","journal-title":"Clin Pharmacokinet."},{"key":"991_CR19","doi-asserted-by":"publisher","first-page":"154","DOI":"10.1016\/j.cmpb.2007.12.002","volume":"90","author":"E Comets","year":"2008","unstructured":"Comets E, Brendel K, Mentr\u00e9 F. Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R. Comput Methods Programs Biomed. 2008;90:154\u201366. https:\/\/doi.org\/10.1016\/j.cmpb.2007.12.002.","journal-title":"Comput Methods Programs Biomed."},{"key":"991_CR20","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1007\/s10928-009-9143-7","volume":"37","author":"K Brendel","year":"2010","unstructured":"Brendel K, Comets E, Laffont C, Mentr\u00e9 F. Evaluation of different tests based on observations for external model evaluation of population analyses. J Pharmacokinet Pharmacodyn. 2010;37:49\u201365. https:\/\/doi.org\/10.1007\/s10928-009-9143-7.","journal-title":"J Pharmacokinet Pharmacodyn."},{"key":"991_CR21","doi-asserted-by":"publisher","first-page":"e000685","DOI":"10.1136\/bmjpo-2020-000685","volume":"4","author":"IC Lutz","year":"2020","unstructured":"Lutz IC, Allegaert K, de Hoon JN, Marynissen H. Pharmacokinetics during therapeutic hypothermia for neonatal hypoxic ischaemic encephalopathy: a literature review. BMJ Paediatr Open. 2020;4:e000685. https:\/\/doi.org\/10.1136\/bmjpo-2020-000685.","journal-title":"BMJ Paediatr Open."},{"key":"991_CR22","doi-asserted-by":"publisher","first-page":"1207","DOI":"10.1002\/jcph.555","volume":"55","author":"TS Samant","year":"2015","unstructured":"Samant TS, Mangal N, Lukacova V, Schmidt S. Quantitative clinical pharmacology for size and age scaling in pediatric drug development: a systematic review. J Clin Pharmacol. 2015;55:1207\u201317. https:\/\/doi.org\/10.1002\/jcph.555.","journal-title":"J Clin Pharmacol."},{"key":"991_CR23","doi-asserted-by":"publisher","first-page":"2941","DOI":"10.1002\/jps.23574","volume":"102","author":"N Holford","year":"2013","unstructured":"Holford N, Heo Y-A, Anderson B. A pharmacokinetic standard for babies and adults. J Pharm Sci. 2013;102:2941\u201352. https:\/\/doi.org\/10.1002\/jps.23574.","journal-title":"J Pharm Sci."},{"key":"991_CR24","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1016\/S0377-1237(17)30436-7","volume":"55","author":"CG Wilson","year":"1999","unstructured":"Wilson CG, Sarkar PK, Mazumdar J, Bharadhwaj B. Study of glomerular functions in neonates. Med J Armed Forces India. 1999;55:183\u20136. https:\/\/doi.org\/10.1016\/S0377-1237(17)30436-7.","journal-title":"Med J Armed Forces India."},{"key":"991_CR25","doi-asserted-by":"publisher","first-page":"1462","DOI":"10.1002\/cpt.1332","volume":"105","author":"J Wang","year":"2019","unstructured":"Wang J, Kumar SS, Sherwin CM, Ward R, Baer G, Burckart GJ, et al. Renal clearance in newborns and infants: predictive performance of population-based modeling for drug development. Clin Pharmacol Ther. 2019;105:1462\u201370. https:\/\/doi.org\/10.1002\/cpt.1332.","journal-title":"Clin Pharmacol Ther."},{"issue":"2","key":"991_CR26","doi-asserted-by":"publisher","first-page":"159","DOI":"10.1002\/jcph.1725","volume":"61","author":"F Salem","year":"2021","unstructured":"Salem F, Johnson TN, Hodgkinson ABJ, Ogungbenro K, Rostami-Hodjegan A. Does, \u201cbirth\u201d as an event impact maturation trajectory of renal clearance via glomerular filtration? Reexamining data in preterm and full-term neonates by avoiding the creatinine bias. J Clin Pharmacol. 2021;61(2):159\u201371. https:\/\/doi.org\/10.1002\/jcph.1725.","journal-title":"J Clin Pharmacol."},{"key":"991_CR27","doi-asserted-by":"publisher","first-page":"682","DOI":"10.4314\/ahs.v14i3.26","volume":"14","author":"D Alaro","year":"2014","unstructured":"Alaro D, Bashir A, Musoke R, Wanaiana L. Prevalence and outcomes of acute kidney injury in term neonates with perinatal asphyxia. Afr Health Sci. 2014;14:682\u20138. https:\/\/doi.org\/10.4314\/ahs.v14i3.26.","journal-title":"Afr Health Sci."},{"key":"991_CR28","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1097\/FTD.0b013e3182834335","volume":"35","author":"LF Mark","year":"2013","unstructured":"Mark LF, Solomon A, Northington FJ, Lee CK. Gentamicin pharmacokinetics in neonates undergoing therapeutic hypothermia. Ther Drug Monit. 2013;35:217\u201322. https:\/\/doi.org\/10.1097\/FTD.0b013e3182834335.","journal-title":"Ther Drug Monit."},{"key":"991_CR29","doi-asserted-by":"publisher","first-page":"50","DOI":"10.1159\/000014195","volume":"77","author":"S Satas","year":"2000","unstructured":"Satas S, Hoem NO, Melby K, Porter H, Lindgren CG, Whitelaw A, Thoresen M. Influence of mild hypothermia after hypoxia-ischemia on the pharmacokinetics of gentamicin in newborn pigs. Biol Neonate. 2000;77:50\u20137. https:\/\/doi.org\/10.1159\/000014195.","journal-title":"Biol Neonate."},{"key":"991_CR30","doi-asserted-by":"publisher","first-page":"844","DOI":"10.1097\/00003246-198510000-00014","volume":"13","author":"G Koren","year":"1985","unstructured":"Koren G, Barker C, Bohn D, Kent G, Biggar WD. Influence of hypothermia on the pharmacokinetics of gentamicin and theophylline in piglets. Crit Care Med. 1985;13:844\u20137. https:\/\/doi.org\/10.1097\/00003246-198510000-00014.","journal-title":"Crit Care Med."},{"key":"991_CR31","doi-asserted-by":"publisher","first-page":"310","DOI":"10.1542\/peds.2008-2942","volume":"124","author":"X Liu","year":"2009","unstructured":"Liu X, Borooah M, Stone J, Chakkarapani E, Thoresen M. Serum gentamicin concentrations in encephalopathic infants are not affected by therapeutic hypothermia. Pediatrics. 2009;124:310\u20135. https:\/\/doi.org\/10.1542\/peds.2008-2942.","journal-title":"Pediatrics"}],"container-title":["Clinical Pharmacokinetics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-021-00991-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40262-021-00991-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40262-021-00991-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T17:31:21Z","timestamp":1628616681000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40262-021-00991-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2,21]]},"references-count":31,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,7]]}},"alternative-id":["991"],"URL":"https:\/\/doi.org\/10.1007\/s40262-021-00991-6","relation":{},"ISSN":["0312-5963","1179-1926"],"issn-type":[{"value":"0312-5963","type":"print"},{"value":"1179-1926","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,2,21]]},"assertion":[{"value":"28 January 2021","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 February 2021","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The ALBINO project is funded under the Horizon 2020 Framework EU Program call H2020-PHC-2015-two-stage, grant 667224. The research on the pharmacokinetics during whole body hypothermia (Karel Allegaert, Pieter Annaert, Anne Smits) is further supported by the iPREDICT project (FWO Senior research project, fundamental research, G0D0520N).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Neel Deferm, Kim V. Annink, Ruben Faelens, Michael Schroth, Christian A. Maiwald, Loubna el Bakkali, Frank van Bel, Manon J.N.L. Benders, Mirjam M. van Weissenbruch, Anja Hagen, Anne Smits, Pieter Annaert, Axel R. Franz, and Karel Allegaert have no conflicts of interest that are directly relevant to the content of this article. Yannique Jacobs is a collaborator within the ALBINO project and is an employee of ACE Pharmaceuticals, Zeewolde, the Netherlands, which holds the Dutch marketing authorization registration for Acepurin<sup>\u00ae<\/sup> (allopurinol 1 g\/100 mL) for intravenous application for the treatment of gout.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest\/Competing Interests"}},{"value":"The Medical Ethics Committee of the University Medical Centre Utrecht and the Central Committee on Human Research approved the study including the specific pharmacokinetic sub-study for the Netherlands (NL57237.041.16). The German Federal Authority (EudractCT 2016-000222-19) as well as the leading Ethics Committee of T\u00fcbingen approved the study for Germany.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Oral consent was obtained from at least one parent before administering the study medication. After the first dose, but before the (potential) second dose, full written parental consent was obtained. In case parents did not sign the informed consent, blood samples already collected shortly after birth were destroyed.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"The raw data are available upon reasonable request by an e-mail to the corresponding author, while blinding for group allocation should be respected until the primary outcome analysis has been finalized.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Protocol development and study conduct: KVA, MS, CM, LEB, FVB, MB, MVW, AH, AF; ethics and study registration: KVA, FVB, MB, AF; study recruitment and data collection: KVA, MS, CM, LEB, FVB, MB, MVW, AH, AF; modeling: ND, RF, AS, PA, KA; drafting of the manuscript: ND, RF, AS, PA, AF, KA. All authors have read and commented on the paper, and have approved the submitted version.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 Contributions"}}]}}