{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T22:29:08Z","timestamp":1769120948044,"version":"3.49.0"},"reference-count":30,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,7,25]],"date-time":"2024-07-25T00:00:00Z","timestamp":1721865600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>There is an increased risk of venous thromboembolism (VTE) among neonates due to their unique hemostatic system. However, there is lack of approved treatment options for VTE in neonatal population. Importantly, dalteparin, a low molecular weight heparin approved for pediatric VTE in children \u22651\u00a0month of age, has also been used for the treatment of neonatal VTE. Based on the request from the Food and Drug Administration, this retrospective study aimed to characterize the safety, clinical effects, and dosing of dalteparin for treatment of VTE among neonates.<\/jats:p><\/jats:sec><jats:sec><jats:title>Procedure<\/jats:title><jats:p>Data from electronic medical records for neonates (born \u226535\u00a0weeks of gestation) treated with dalteparin for VTE between January 2010 and December 2021 were collected. The data assessed included bleeding and deterioration in hematological biomarkers among other adverse events, changes in relevant factor antifactor Xa (anti\u2010Xa) levels and VTE status, and dosing of dalteparin and corresponding anti\u2010Xa assay levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixteen neonates from five participating sites in the United Kingdom were included. There were no bleeding events or deaths. Only one serious adverse event of hypoglycemic brain injury (unrelated to dalteparin) was documented in a patient with a history of hyperinsulinism. Median (range) daily dose of dalteparin at initiation was 309 (297\u2013314)\u00a0IU\/kg. Eight of 16 neonates achieved therapeutic anti\u2010Xa level, including two patients who did so after the first dose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Dalteparin treatment in neonates raised no major safety concerns. Larger cohort studies may help provide further insights on clinical effects of dalteparin for neonatal VTE.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pbc.31215","type":"journal-article","created":{"date-parts":[[2024,7,26]],"date-time":"2024-07-26T05:34:57Z","timestamp":1721972097000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Retrospective study evaluating safety, clinical effect, and dosing of dalteparin for the treatment of venous thromboembolism in term neonates"],"prefix":"10.1002","volume":"71","author":[{"given":"Nancy","family":"Sherman","sequence":"first","affiliation":[{"name":"Pfizer Inc.  Collegeville Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1103-296X","authenticated-orcid":false,"given":"Muhammad","family":"Younus","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Collegeville Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Wolter","sequence":"additional","affiliation":[{"name":"Pfizer Inc.  Collegeville Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5314-7626","authenticated-orcid":false,"given":"Suresh","family":"Victor","sequence":"additional","affiliation":[{"name":"King's College London and Guy's and St Thomas\u2019 NHS Foundation Trust  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Venkatesh","family":"Kairamkonda","sequence":"additional","affiliation":[{"name":"University Hospitals of Leicester NHS Trust  Leicester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleri","family":"Adams","sequence":"additional","affiliation":[{"name":"Oxford University Hospitals NHS Foundation Trust  Leicester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Brotherton","sequence":"additional","affiliation":[{"name":"Victoria Hospital Kirkcaldy NHS Fife  Kirkcaldy UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elaine M.","family":"Boyle","sequence":"additional","affiliation":[{"name":"University Hospitals of Leicester NHS Trust  Leicester UK"},{"name":"University of Leicester  Leicester UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,7,25]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amepre.2009.12.017"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2017.00068"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V83.5.1251.1251"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2004.06.021"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2017.00198"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2017.12.015"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2009\u20100768"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1179\/027249309X12547917868961"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1159\/000513784"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12959\u2010018\u20100182\u20104"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2014.05.036"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1055\/s\u20100041\u20101740267"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1155\/2011\/217564"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2019001847"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/cvr\/cvt343"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.28688"},{"key":"e_1_2_11_18_1","unstructured":"FRAGMIN (dalteparin sodium) injection.Pfizer. 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