Having trouble logging in? Sign up for a free account Get unlimited access on Medscape. Vitamin K is necessary for synthesis of factors II (prothrombin), VII, IX, and X Vitamin K is undetectable in cord blood Lactobacillus (primary gut flora in breastfed babies) does not synthesize vitamin K Breastmilk contains only small amounts of vitamin K (1 – 9 mcg/L); Vitamin K Deficiency Bleeding (aka “Hemorrhagic Disease of the Newborn”) can result Incidence of VKDB reported varies from 1.5% to 0.001% , depending on population studied and feeding patterns (formula is protective since it’s supplemented with vit K) Early onset disease – onset within first 24 hours Classic disease – onset between day 2 – 7 Late onset disease – onset between 2 weeks and 6 months Items in italics are most common form of initial presentation. Clinical bleeding manifest in one or multiple areas: GI bleed (classic dz) bleeding from injection sites
intracranial bleed (late dz) Seemingly insignificant bleeds (“warning bleeds”) or subtle FTT may precede the heralding event based on clinical bleeding with abnormal PT/INR plts NL, fibrinogen NL, +/- anemia, +/- abnormal PTT, +/- decreased factor II,VII, IX,X levels 1 mg vitamin K SQ (preferred) or IV (risk of anaphylaxis) biochemical response (normalized PT) is rapid, 4 – 6 hours Maternal anti-sz meds that interfere with vitamin K metabolism (phenytoin, phenobarbital, carbamezepine, or primidone) Maternal anti-coagulants (coumadin, aspirin) Maternal antibiotics, especially cephalosporins Marginal levels of vitamin K in breast milk 0.5mg – 1mg vitamin K IM at birth If Parents Refuse IM Vitamin K: 2 – 4mg PO vitamin K after first feeding then 2mg at 2 – 4 weeks and again at 6 – 8 weeks 2 – 4mg PO vitamin K after first feeding then 2mg within first week and weekly while breastfeeding 2mg PO vitamin K after first feeding then 2mg within first week followed by 25mcg daily for 13 weeks
Notes about Oral Regimens there is no licensed PO form in the US in countries that have gone to PO prophylaxis, failures (even with good compliance) have been reported . Failures have not been reported with IM prophylaxis. since multiple doses are required, compliance is an issue advise parents regarding the increased risk of VKDB (exact numbers are unknown) maternal dietary changes have little effect on overall vitamin K status of newborn maternal vitamin K supplements of 5mg/day (800% RDA) has been shown in one study to raise infant serum levels to near formula-fed levels, but there is no FDA approved MVI that contains this amount of vitamin K Does vitamin K cause cancer? One study published in the British Medical Journal in 1990 raised this concern, suggesting that the risk of cancer was doubled in babies who received vitamin K at birth. Many studies since then in Europe and in US have refuted this claim and found no association between the two.
Only one other study (aside from 1992 paper from the same author) suggested a possible association between vitamin K and the risk of ALL. There is good consensus among experts that IM vitamin K prophylaxis is safe and is not associated with childhood cancer. Does vitamin K cause jaundice? There were reports of hemolytic anemia and hyperbilirubinemia severe enough to cause kernicterus in the mid 1950s with high doses (50mg) of vitamin K2 (menadione). As a result, use of this form of vitamin K was abandoned. We now give infants vitamin K1 (phytonadione). Vitamin K1 has been associated with hyperbilirubinemia only in extremely high doses (25 – 30mg). The effect was particularly seen in premies, though it was also present - albeit to a lesser degree - in term infants. This has not been a problem when vitamin K1 is given in normal therapeutic doses (0.5 - 1mg). What other side effects have been reported? Anaphylaxis, though most common after IV infusion, has rarely been reported with IM injection.
Scleroderma-like patch at the site of injection has been reported primarily in adults after repeated injections, though there are reports of 7 infants with similar dermatologic reactions (again, millions of doses are given without problems). American Academy of Pediatrics, Committee on Fetus and Newborn. Controversies Concerning Vitamin K and the Newborn. Ross, JA, Davies SM. Vitamin K prophylaxis and childhood cancer. Cornelissen, M., et al. Prevention of vitamin K deficiency bleeding: efficacy of different multiple oral dose schedules of vitamin K. Greer, FR, et al. Improving the vitamin K status of breastfeeding infants with maternal vitamin K supplements. Hansen KN1, Minousis M, Ebbesen F.Author information1Department of Paediatrics, Viborg-Kjellerup Hospital, Denmark. vsb24knh@vibamt.dkAbstractAIM: To evaluate oral vitamin K prophylaxis at birth by giving 2 mg phytomenadione, followed by weekly oral vitamin K prophylaxis; 1 mg was administered by the parents until 3 mo of age.
METHODS: A total of 507850 live babies were born in Denmark during the study period, November 1992 to June 2000. Of these infants, 78% and 22% received oral and intra-muscular prophylaxis, respectively; i.e. about 396000 neonates received oral prophylaxis at birth. Weekly oral prophylaxis was recommended for all infants as long as they were mainly breastfed. A survey of possible cases of vitamin K deficiency bleeding (VKDB) was carried out by repeated questionnaires to all Danish paediatric departments and by checking the National Patient Register.RESULTS: No cases of VKDB were revealed, i.e. the incidence was 0-0.9:100000 (95% CI). The questionnaires were used to evaluate compliance with the regimen. Parents of 274 infants participated. A dose of vitamin K was regarded as having been given if the infant received a drop of vitamin K or was mostly formula-fed that week, and the prophylaxis was regarded as completed if the infant had received at least 9 doses. Compliance was good, with 94% of the infants completing the course of prophylaxis.
CONCLUSION: Weekly oral vitamin K supplementation during the first 3 mo of life was an efficient prophylaxis against VKBD. Parental compliance with the regimen was good.PMID: 12892158 [Indexed for MEDLINE] MeSH termsAntifibrinolytic Agents/therapeutic use*Breast FeedingChild Health Services/organization & administrationDenmark/epidemiologyDrug Administration ScheduleDrug Therapy, CombinationFood, FortifiedHealth PromotionHumansIncidenceInfant WelfareInfant, NewbornPatient Compliance/statistics & numerical dataPreventive Health Services/organization & administrationSurveys and QuestionnairesVitamin K/administration & dosageVitamin K/therapeutic use*Vitamin K 1/administration & dosageVitamin K 1/therapeutic use*Vitamin K Deficiency/epidemiologyVitamin K Deficiency/prevention & control*Vitamin K Deficiency Bleeding/epidemiologyVitamin K Deficiency Bleeding/etiology*Vitamin K Deficiency Bleeding/prevention & control*SubstancesAntifibrinolytic AgentsVitamin KVitamin K 1Full Text SourcesWileyOvid