From the Guidelines
The recommended dose of vitamin K for term newborns is a single intramuscular injection of 1 mg of vitamin K1 (phytonadione) administered shortly after birth, typically within the first 6 hours of life. This is based on the most recent and highest quality study available, which prioritizes the prevention of vitamin K deficiency bleeding and its potential devastating consequences, including permanent brain damage or death 1. The intramuscular injection is usually given in the anterolateral aspect of the thigh. For parents who decline the injection, an oral regimen can be offered, but it is less reliable in preventing late vitamin K deficiency bleeding. Vitamin K is essential for the production of clotting factors II, VII, IX, and X in the liver, and newborns have naturally low vitamin K levels due to its limited transfer across the placenta, sterile intestines at birth, and low amounts in breast milk.
Some key points to consider:
- The American Academy of Pediatrics recommends routine administration of vitamin K to all newborns to prevent vitamin K deficiency bleeding 1.
- The oral regimen is less reliable and consists of 2 mg of vitamin K1 at birth, followed by 2 mg at 1-2 weeks of age, and a final 2 mg at 4-6 weeks of age.
- Vitamin K deficiency bleeding can cause serious hemorrhage, particularly intracranial bleeding, with potentially devastating consequences.
- The most recent guidelines from the European Society of Gastroenterology, Hepatology and Nutrition recommend a single intramuscular injection of 1 mg of vitamin K1 at birth 1.
Overall, the evidence supports the use of a single intramuscular injection of 1 mg of vitamin K1 at birth as the most effective way to prevent vitamin K deficiency bleeding in term newborns.
From the FDA Drug Label
The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of Vitamin K1 Injection 0. 5 to 1 mg within one hour of birth is recommended. The recommended Vitamin K dose for a term newborn is 0.5 to 1 mg given intramuscularly within one hour of birth for prophylaxis of hemorrhagic disease of the newborn 2.
From the Research
Vitamin K Dose for Term Newborns
- The American Academy of Pediatrics has recommended intramuscular administration of vitamin K for prevention of vitamin K deficiency bleeding (VKDB) in newborns since 1961 3.
- A single intramuscular injection of vitamin K is effective in preventing both classic and late VKDB 4.
- The optimal dose of vitamin K for term newborns is not explicitly stated in the provided studies, but a study on premature infants suggests that 0.5 mg of vitamin K may be sufficient to prevent hemorrhagic disease of the newborn 5.
- Another study suggests that 0.3 mg/kg may be used for babies with birth weights below 1000 g 5.
- It is essential to note that parental refusal of routine prophylaxis can have serious long-term neurodevelopmental consequences for some newborns, who may subsequently develop vitamin K deficiency-associated hemorrhagic disease of the newborn (HDN) 6.
- Oral administration of vitamin K is also effective in preventing VKDB, but the success of oral prophylaxis depends on the protocol regimen and parent compliance 7.
Administration Methods
- Intramuscular administration is considered a standard of care for vitamin K prophylaxis in newborns 4, 3.
- Oral administration is also used, but it requires multiple doses and has varying success rates depending on the protocol and parent compliance 7.
Importance of Vitamin K Prophylaxis
- Vitamin K deficiency bleeding can occur in the first week of life ("classic" VKDB) and also between 2 weeks and 3 months of age ("late" VKDB) 4.
- VKDB can present as bleeding in the skin or gastrointestinal tract, with as many as half of affected neonates experiencing intracranial bleeding 4.
- Vitamin K prophylaxis is essential to prevent VKDB and its potential long-term consequences 4, 7, 3, 6.