{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T17:31:40Z","timestamp":1787938300761,"version":"build-2784847793"},"reference-count":21,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Traditional milligram per kilogram (mg\/kg) dosing of enoxaparin in neonates frequently fails to achieve target anti\u2010Xa levels promptly, necessitating repeated laboratory monitoring and dose adjustments. This study investigated whether a personalized dosing strategy based on predicted individual clearance and volume of distribution could improve outcomes, comparing standard\u2010of\u2010care (SOC) mg\/kg dosing to pharmacokinetic (PK) model\u2010informed precision dosing (MIPD). A retrospective analysis was conducted on hospitalized neonates treated with enoxaparin at less than 44\u2009weeks postmenstrual age from 2019 to 2022. Data on demographics, drug dosing, PK model covariates, and clinical outcomes were extracted from electronic health records and analyzed using the Pumas\u2010AI Lyv dosing tool. The primary focus was on comparing the initial SOC dose to the MIPD\u2010recommended dose. The secondary outcome measured was the time required to achieve therapeutic anti\u2010Xa levels. The study included 168 neonates with a median postnatal age of 15\u2009days (range 1\u2013149) and a median dosing weight of 3.1\u2009kg (range: 0.82\u20135.2). MIPD\u2010recommended initial doses were 20%\u201360% higher than SOC doses in 32% of the cases and over 60% higher in 11% of cases. Neonates who received SOC doses that were much lower than the MIPD recommendation showed the longest delays in reaching therapeutic anti\u2010Xa levels. The results indicate that PK model\u2010informed of enoxaparin dosing leads to higher initial dosages than SOC in neonates, potentially reducing the time to therapeutic anti\u2010Xa levels. These findings are being utilized to define dosing limits for a prospective trial of MIPD in neonatal intensive care settings.<\/jats:p>","DOI":"10.1111\/cts.70040","type":"journal-article","created":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T10:38:31Z","timestamp":1727779111000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmacokinetic model\u2010guided enoxaparin dosing in the Neonatal ICU: Retrospective cohort study to plan for prospective feasibility trial"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2877-1627","authenticated-orcid":false,"given":"Haden","family":"Bunn","sequence":"first","affiliation":[{"name":"Pumas\u2010AI, Inc  Dover Delaware USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Schentag","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology &amp; Toxicology The Hospital for Sick Children  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7711-4530","authenticated-orcid":false,"given":"Leonardo R.","family":"Brand\u00e3o","sequence":"additional","affiliation":[{"name":"Division of Hematology Oncology The Hospital for Sick Children  Toronto Ontario Canada"},{"name":"Dalla Lana School of Public Health University of Toronto  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6433-1154","authenticated-orcid":false,"given":"Vijay","family":"Ivaturi","sequence":"additional","affiliation":[{"name":"Pumas\u2010AI, Inc  Dover Delaware USA"},{"name":"The University of Maryland School of Pharmacy  Baltimore Maryland USA"},{"name":"Centre for Pharmacometrics Manipal University  Manipal Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2137-8339","authenticated-orcid":false,"given":"Tamorah","family":"Lewis","sequence":"additional","affiliation":[{"name":"Division of Clinical Pharmacology &amp; 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