From the Guidelines
Vitamin K Deficiency Bleeding (VKDB) is a rare but potentially fatal condition that can be effectively prevented with a single intramuscular injection of vitamin K1 (phytonadione) at a dose of 1 mg within the first hours after birth. The prevalence of VKDB is approximately 4-7 per 100,000 births without prophylaxis 1.
Prevention of VKDB
To prevent VKDB, the following options are recommended:
- A single intramuscular injection of vitamin K1 (phytonadione) at a dose of 1 mg within the first hours after birth
- Oral vitamin K1, with a dose of 3 × 2 mg at birth, at 4 to 6 days, and at 4 to 6 weeks, or 2 mg, although this is less reliable than intramuscular injection 1
- For term newborns and infants, vitamin K1 orally at birth, and a weekly dose of 1 mg orally for 3 months 1
Current Prophylaxis Practices and Outcomes
Current prophylaxis practices and outcomes for VKDB have been extensively discussed by Mihatsch and the Committee on Nutrition of ESPGHAN, who recommend intramuscular application as the preferred route 1.
Recommendations for Prevention
The European Society of Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends that healthy newborn infants should receive either 1 mg of vitamin K1 by intramuscular injection at birth or 3 × 2 mg vitamin K1 orally at birth, at 4 to 6 days, and at 4 to 6 weeks, or 2 mg 1. Intramuscular application is the preferred route, as it provides more reliable protection against VKDB 1. VKDB occurs because newborns have naturally low vitamin K levels at birth, as this vitamin doesn't cross the placenta efficiently and isn't abundant in breast milk 1. Without supplementation, infants lack sufficient vitamin K to activate clotting factors, putting them at risk for severe bleeding, particularly intracranial hemorrhage, which can cause permanent brain damage or death 1. The single injection provides protection during the critical first months of life until the infant's gut bacteria develop to produce adequate vitamin K naturally.
From the FDA Drug Label
Vitamin K1 Injection is indicated in: ... prophylaxis and therapy of hemorrhagic disease of the newborn; The FDA drug label does not answer the question.
From the Research
Prevalence of Infant Deaths due to VKDB
- The prevalence of infant deaths due to Vitamin K Deficiency Bleeding (VKDB) is a significant concern, with studies indicating that it can be largely prevented by adequate vitamin K supplementation 2.
- VKDB can occur in the first week of life ("classic" VKDB) and also between 2 weeks and 3 months of age ("late" VKDB), with late-onset VKDB being life-threatening 3, 4.
- The median burden of late VKDB was found to be 35 per 100,000 live births in infants who had not received prophylaxis at birth, with a higher burden in low- and middle-income countries compared to high-income countries 5.
Prevention of VKDB
- All newborn infants should receive vitamin K prophylaxis, with the date, dose, and mode of administration documented 2.
- Healthy newborn infants can receive either 1 mg of vitamin K1 by intramuscular injection at birth or 3 × 2 mg vitamin K1 orally at birth, at 4 to 6 days, and at 4 to 6 weeks 2.
- Intramuscular application is the preferred route for efficiency and reliability of administration, while oral administration requires multiple doses and depends on compliance with the protocol 2, 3.
- Exclusive breastfeeding and cholestasis are closely associated with VKDB, and intramuscular prophylactic injections can reduce the incidence of early-onset, classic, and late-onset VKDB 3, 4.
Epidemiology and Prophylaxis Strategy
- Vitamin K deficiency commonly occurs in newborns who are exclusively breastfed, and Protein Induced by VK Absence (PIVKA-II) has been identified as an early indicator of subclinical VK deficiency in neonates 6.
- A multicentre study found that oral supplementation of VK1 after discharge significantly reduced PIVKA-II concentrations in exclusively breastfed term infants, suggesting the importance of oral VK1 supplementation during the first 3 months of life 6.
- A systematic review found that routine intramuscular administration of 1 mg of vitamin K at birth reduces the incidence of late VKDB during infancy, and that multiple oral doses do not increase the risk of VKDB compared to intramuscular prophylaxis 5.