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Methods describe an open-labeled randomized controlled trial of healthy vaginally delivered neonates; exclusions include maternal antiepileptics, anti-tuberculous drugs, warfarin, and bleeding-disorder history. PIVKA II was measured by ELISA in cord blood and at 30 and 72 days; levels >100 ng/mL indicated subclinical VKDB. Results show similar PIVKA II levels between groups with only a significant reduction in the 1 mg arm by day 72.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/one-milligram-versus-two-milligram-intramuscular-vitamin-k-to-prevent-late-onset-hemorrhagic-disease-in-young-infants-a-randomized-controlled-trial/658373/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/one-milligram-versus-two-milligram-intramuscular-vitamin-k-to-prevent-late-onset-hemorrhagic-disease-in-young-infants-a-randomized-controlled-trial/658373.png","ImageObject",300,407,{"name":92,"@type":93},"Ivy","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-10-26",true,{"@type":102,"interactionType":103,"userInteractionCount":14},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the primary objective of the trial?","Question",{"text":112,"@type":113},"To compare the efficacy of 1 mg versus 2 mg intramuscular vitamin K in reducing subclinical late-onset VKDB, assessed using PIVKA II levels.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How were participants selected and what were the key exclusions?",{"text":117,"@type":113},"Healthy term neonates delivered vaginally with normal Apgar scores were included. Neonates were excluded if mothers used antiepileptics, anti-tuberculous drugs, warfarin, or if there was a family history of bleeding disorders or suspected bleeding disorder.",{"name":119,"@type":110,"acceptedAnswer":120},"What did the study measure and how was subclinical VKDB defined?",{"text":121,"@type":113},"PIVKA II levels were measured in cord blood and at 30 and 72 days using ELISA. PIVKA II >100 ng/mL was classified as subclinical VKDB.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},658373,1793063662,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":24,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},549758252649,"https://ap-avatar.wpscdn.com/avatar/8000253669c5317157?_k=1778319167496531819","|  | ORIGINAL ARTICLE |  |\n| --- | --- | --- |\n|  |  |  |\n| One Milligram Versus Two Milligram Intramuscular Vitamin K to Prevent Late-Onset Hemorrhagic Disease in Young Infants:\u003Cbr>A Randomized Controlled Trial\u003Cbr>Amala SrilathaNatarajan,1 Delhikumar CG ,1 Senthil Kumar GP,2 NiveditaMondal,1 SasirekhaR3\u003Cbr>Departments of 1Pediatrics, 2Biochemistry and 3Obstetrics and Gynecology, Jawaharlal Institute of Postgraduate Medical\u003Cbr>Education and Research (JIPMER), Puducherry, India\u003Cbr>ABSTRACT\u003Cbr>Objectives: To compare the efficacy of a standard dose (1 mg) with 2 mg vitamin K administered by intramuscular (IM) route in reducing subclinical late-onset vitamin K deficiency bleeding (VKDB) assessed using serum protein induced by vitamin K absence (PIVKA II) levels.\u003Cbr>Methods: This was an open-labeled randomized controlled trial that enrolled healthy term neonates delivered vaginally. Neonates delivered tomothers receiving antiepileptics, anti-tuberculous drugs, or warfarin, and those with a family history of bleeding disorder were excluded. Participants were randomized to receive either 1 or 2 mg of vitamin K1 (Phytomenadione) IM at birth. PIVKA II was measured in the cord blood and at 30 and 72 days afterbirth byELISA method. PIVKA II level >100 ng/mL was labeled as subclinical VKDB.\u003Cbr>Results: Forty-one neonates were recruited in each arm. On the 30 days follow-up visit 9 infants (4 in 1 mg group; 5 in 2 mg group) were lost to follow-up. All babies had PIVKA II levels >100 ng/mL at birth. The median PIVKA II values (ng/mL) in the 1 mg group were 827.68 (cord blood), 678.80 (30 days), and 644.10 (72 days). The corresponding levels (ng/mL) in the 2 mg group were higher, viz., 770.55, 726.35, and 693.14 ng/mL; P > 0.05 for all comparisons. PIVKA II level in the 1 mg group reduced significantly on 72 days of life compared to that observed at birth (cord blood) (P= 0.012). However, the fall in 2 mg group was not statistically significant.\u003Cbr>Conclusion: There was no difference in PIVKA II levels between neonates receiving 1 mg or 2 mg vitamin KIM suggesting a similar risk for late-onset VKDB in both groups.\u003Cbr>Keywords: Bleeding disorder, Phytomenadione, PIVKA II, Prophylaxis, VKDB |  |  |\n\nTrial Registry: CTRI/2022/05/042625  \nINTRODUCTION  \nNewborns have low vitamin K levels at birth because of the limited placental transfer, immature gut, and inadequate levels in breast milk (1-2 mcg/L) [1] . Thus, neonates are at a high risk of vitamin K deficiency bleeding (VKDB) . The incidence of classical VKDB without vitamin K prophylaxis is 1.7%, and the burden of late VKDB without prophylaxis is 80 per 100,000 live births [2] . In India, all newborns with a birth weight of 1000 g or more are administered 1 mg of vitamin K by intramuscular (IM) route while those weighing less than 1000 g receive a dose of 0.5 mg [3] . In case of parental refusal for injection, three oral doses of 2 mg vitamin K at birth, 4 to 6 days, and 4 to 6 weeks can be given [4,5]. A  \nCorrespondence to: Dr. Delhi Kumar CG, Additional Professor, Department of Pediatrics, JIPMER, Puducherry-605006, India. [dillikumar14@gmail.com](dillikumar14@gmail.com)  \nReceived: Mar 26, 2024; Initial review: May18, 2024;  \nAccepted: Oct 13, 2024  \nsingle vitamin K injection has been shown to reduce the incidence of late VKDB to 0.24-3.2 cases per 100,000 live births [6] . Late-onset VKDB may manifest as intracranial hemorrhage (ICH) in 50-80% of cases inspite of receiving vitamin K prophylaxis at birth [7]. ICH may result in long-term neurological sequelae such as cerebral palsy, hydrocephalus, or death [2,8], and indicates the need to develop effective prophylaxis protocols to prevent VKDB. Protein induced by vitamin K absence (PIVKA II) is the inert precursor of prothrombin (factor II) synthesized by the liver in vitamin K deficiency. Detection of these proteins is a sensitive and specific marker for subclinical vitamin K deficiency. This study aimed to compare 1 mg and a higher dos","cbCaia9HJUYVrL9F","https://ap.wps.com/l/cbCaia9HJUYVrL9F","pdf",411928,"English","# Abstract\n# Trial Registry\n# Introduction\n# Methods","[{\"question\":\"What was the primary objective of the trial?\",\"answer\":\"To compare the efficacy of 1 mg versus 2 mg intramuscular vitamin K in reducing subclinical late-onset VKDB, assessed using PIVKA II levels.\"},{\"question\":\"How were participants selected and what were the key exclusions?\",\"answer\":\"Healthy term neonates delivered vaginally with normal Apgar scores were included. Neonates were excluded if mothers used antiepileptics, anti-tuberculous drugs, warfarin, or if there was a family history of bleeding disorders or suspected bleeding disorder.\"},{\"question\":\"What did the study measure and how was subclinical VKDB defined?\",\"answer\":\"PIVKA II levels were measured in cord blood and at 30 and 72 days using ELISA. PIVKA II \\u003e100 ng/mL was classified as subclinical VKDB.\"}]","One Milligram Versus Two Milligram Intramuscular Vitamin K to Prevent Late-Onset Hemorrhagic Disease in Young Infants: A Randomized Controlled Trial | PDF",1793048435,13]