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Vitamin K Prophylaxis in Newborns and Bleeding in Infancy

Eleni Simatou1,2, Eleni Tsamantioti1, Anna Hallström3

  • 1Division of Clinical Epidemiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden.

JAMA Pediatrics
|July 13, 2026
PubMed

Insights

Newborns not receiving vitamin K prophylaxis face a higher risk of bleeding, including intracranial hemorrhages. Despite low rates, refusal is increasing, highlighting the need for parental education on vitamin K

Area of Science:

  • Neonatal health
  • Pediatric medicine
  • Public health

Background:

  • Vitamin K deficiency bleeding (VKDB) is a rare but severe condition in infants.
  • Newborn intramuscular vitamin K prophylaxis is an effective preventive measure.
  • Global reports indicate a rise in parental refusal of vitamin K prophylaxis.

Purpose of the Study:

  • To analyze trends in prophylactic newborn vitamin K administration.
  • To assess the association between vitamin K administration and infant bleeding diagnoses.

Main Methods:

  • Nationwide cohort study in Sweden (2003-2021) including live births at ≥35 weeks gestation.
  • Exposure: Nonreceipt of intramuscular vitamin K at birth.
  • Primary outcome: Bleeding diagnosis within the first 6 months of life; logistic regression analysis.

Main Results:

  • Over 2 million infants studied; 1.32% did not receive vitamin K in 2003, decreasing to 0.66% in 2006, then rising to 1.50% by 2021.
  • Infants without vitamin K prophylaxis had 1.54 times higher odds of bleeding.
  • Significantly higher odds (3.18-fold) of intracranial bleeding were observed in non-prophylaxed infants.

Conclusions:

  • The incidence of nonreceipt of newborn vitamin K prophylaxis is low but increasing in Sweden.
  • Infants not receiving vitamin K have a substantially elevated risk of bleeding, including intracranial hemorrhage.
  • Reinforces the critical importance of newborn vitamin K administration and parental education on its benefits.
Abstract

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