Objective:

This systematic review and meta-analysis sought to determine the global prevalence of VKDB-associated ICH and to identify the factors underlying its variation across regions.

Background:

Although vitamin K prophylaxis has been available for decades, late-onset vitamin K deficiency bleeding (VKDB) continues to cause severe intracranial hemorrhage in otherwise healthy infants. Regional inequalities in healthcare access and inconsistencies in national policies may play a major role in its persistence.

Design/Methods:

A comprehensive literature search was conducted across PubMed, Scopus, Embase, and Web of Science from database inception to October 2025. Observational studies reporting late-onset vitamin K deficiency bleeding (VKDB) in infants aged between 2 week and 6 months were included. Data extraction and quality assessment were independently performed by two reviewers using the Newcastle–Ottawa Scale. Random-effects models were used to estimate pooled prevalence rates.

Results:

12 studies met our inclusion criteria. Overall, intracranial hemorrhage occurred in approximately 67% of infants with late VKDB, though estimates varied substantially across settings (I² = 0%). Subdural and parenchymal bleeds predominated, with reported mortality ranging from 20-40%. Regional differences were most pronounced in Asia than in Western Europe.

Conclusions:

Late-onset VKDB continues to be an underrecognized but preventable cause of intracranial hemorrhage in infants, especially where vitamin K prophylaxis is inconsistently implemented. Broader adoption of standardized intramuscular prophylaxis and strengthened surveillance systems are essential to reduce avoidable neurological injury and infant deaths worldwide.