Prophylactic Dosing of Vitamin K to Prevent Bleeding

Pediatrics. 2016 May;137(5):e20154222. doi: 10.1542/peds.2015-4222.


Background and objectives: Based on a high incidence of Vitamin K deficiency bleeding (VKDB) in breastfed infants with thus far unrecognized cholestasis, such as biliary atresia (BA), the Dutch regimen to prevent VKDB in breastfed infants was changed from a daily oral dosage of 25 µg to 150 µg vitamin K. Infants continued to receive 1 mg of vitamin K orally at birth. We compared the efficacy of the 150-µg regimen with the 25-µg regimen and with the Danish regimen of a single intramuscular (IM) dose of 2 mg vitamin K at birth.

Methods: Data were retrieved from the national BA registries: 25 µg group (Netherlands, January 1991 to February 2011); 150 µg group (Netherlands, March 2011 to January 2015); and IM 2 mg group (Denmark, July 2000 to November 2014). We compared the incidence of VKDB in the groups.

Results: VKDB occurred in 45 of 55 (82%) infants of the 25 µg group, in 9 of 11 (82%) of the 150 µg group, but in only 1 of 25 (4%) of the IM 2 mg group (P < .001). Forty percent of all infants of the 25 µg group had an intracranial hemorrhage as presenting symptom, compared with 27% of the infants of the 150 µg group (P = .43). Intracranial hemorrhage was not observed in the IM 2 mg group (0%; P < .001).

Conclusions: A vitamin K prophylactic regimen of 1 mg of vitamin K orally at birth followed by a daily oral dosage of either 25 or 150 µg fails to prevent VKDB in breastfed infants with still unrecognized BA. The data support 2 mg vitamin K IM at birth as prophylaxis against VKDB.

MeSH terms

  • Administration, Oral
  • Biliary Atresia / complications*
  • Biliary Atresia / diagnosis
  • Breast Feeding
  • Delayed Diagnosis
  • Denmark
  • Drug Administration Schedule
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Injections, Intramuscular
  • Male
  • Netherlands
  • Risk Factors
  • Vitamin K / administration & dosage*
  • Vitamin K / therapeutic use
  • Vitamin K Deficiency Bleeding / complications*
  • Vitamin K Deficiency Bleeding / prevention & control*


  • Vitamin K