Historical Mortality from Vitamin K Deficiency Bleeding in Newborns
Without routine vitamin K prophylaxis, an estimated 250 to 1,700 newborns per 100,000 births (0.25% to 1.7%) developed early vitamin K deficiency bleeding, with late-onset disease affecting 10.5 to 80 per 100,000 births, resulting in death or severe neurologic sequelae in approximately half of those with intracranial hemorrhage. 1, 2
Historical Incidence and Mortality
Early and Classic VKDB (First Week of Life)
- Before prophylaxis became standard, early vitamin K deficiency bleeding occurred in 250 to 1,700 cases per 100,000 births 1
- This translates to approximately 0.25% to 1.7% of all newborns developing bleeding complications in the first week of life 1
Late-Onset VKDB (2 Weeks to 6 Months)
- Late-onset disease affected 10.5 to 80 per 100,000 births in Europe without prophylaxis 2
- In Southeast Asia, particularly rural low-income areas, approximately 0.1% (100 per 100,000) of infants suffered intracranial bleeding from late VKDB 2
- Up to 50% of infants with late VKDB experienced intracranial hemorrhage, which is life-threatening and often results in death or permanent neurologic damage 3, 4
Why Newborns Were Vulnerable
Physiologic Risk Factors
- Newborns have physiologically decreased plasma levels of vitamin K-dependent coagulation factors (factors II, VII, IX, and X) compared to adults 5
- Poor placental transfer of vitamin K during pregnancy 4
- Immature gut flora unable to synthesize adequate vitamin K 4
- Low vitamin K content in breast milk, making exclusively breastfed infants particularly susceptible 5, 6
Clinical Presentations That Led to Death
- Intracranial hemorrhage was the most devastating presentation, occurring in approximately 50% of late VKDB cases 3
- Gastrointestinal bleeding 3
- Large intramuscular hemorrhages 7
- Generalized ecchymoses 7
Impact of Universal Prophylaxis
The introduction of routine intramuscular vitamin K prophylaxis (0.5 to 1 mg at birth) has made VKDB rare in developed countries, effectively preventing both classic and late-onset disease. 8, 3
Current Recommendations
- The American Academy of Pediatrics recommends a single intramuscular dose of 0.5 to 1.0 mg vitamin K1 within one hour of birth 9, 8
- This single injection effectively prevents both classic and late VKDB 3
- Intramuscular administration is the preferred route for efficiency and reliability 6
Ongoing Public Health Concern
- VKDB has reemerged in some populations due to parental refusal of intramuscular vitamin K, with refusal rates ranging from 0% to 3.2% in US hospitals, up to 14.5% in home births, and up to 31.0% in birthing centers 1
- Parents who refuse intramuscular vitamin K are more likely to refuse immunizations 1
- Parental refusal should be documented because of the serious risk of late VKDB 6