Vitamin K deficiency bleeding (VKDB) prevention in newborns

Bleeding in the first days and weeks of life due to physiological vitamin K deficiency in newborns. The fetus and newborn have minimal vitamin K stores: the placenta transfers it poorly, gut microbiota is not yet established, and breast milk contains little vitamin K. Without prophylaxis, 0.25–1.7 % of infants develop VKDB. Late VKDB (weeks 2–12) causes intracranial haemorrhage with up to 20 % mortality and severe disability in survivors. Standard prophylaxis is intramuscular vitamin K1 (phytomenadione) 1 mg immediately after birth.

ICD-10 P531 drug

Also known as: Hemorrhagic disease of the newborn, HDN, Vitamin K deficiency bleeding, VKDB

Drugs used for this condition

APhytomenadioneFirst line · Vitamin K1, haemostatic, antidote for coumarin anticoagulant overdoseGlobal paediatric standard: vitamin K1 1 mg intramuscularly once within the first 6 hours of life for term newborns; 0.4 mg/kg for preterm under 1,500 g, 0.5–1 mg for preterm above 1,500 g. AAP, NICE NG194, and WHO 2022 unanimously recommend the intramuscular route. Alternative oral regimens (3 doses of 2 mg on days 1, 4–7, and 28) are acceptable when parents refuse injection, but efficacy is lower: late VKDB rate is 1.2–6.4 per 100,000 live births with oral regimens versus 0.25 per 100,000 after IM. Without prophylaxis, late VKDB causes intracranial haemorrhage with up to 20 % mortality and severe disability. K1 (phytomenadione) is used for this purpose, not K3 (Vikasol) – K3 causes haemolytic anaemia in neonates.

How to read tiers A–F

Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit