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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
Summary
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.
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