What is the recommended dose of Vitamin K (Vitamin K) for a term newborn?

From the Guidelines

The recommended vitamin K dose 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 injection is usually given in the anterolateral aspect of the thigh. For parents who decline the injection, an oral regimen can be offered consisting of 2 mg oral vitamin K at birth, followed by 2 mg at 1-2 weeks of age, and a final 2 mg at 4-6 weeks of age. However, the oral regimen is less reliable in preventing late vitamin K deficiency bleeding.

Key Points

• Vitamin K is essential for newborns because they are born with low vitamin K levels and limited gut bacteria to produce it naturally.
• Without supplementation, newborns are at risk for vitamin K deficiency bleeding (VKDB), which can cause serious internal bleeding, including intracranial hemorrhage.
• Breast milk contains low levels of vitamin K, making supplementation particularly important for breastfed infants.
• The 1 mg dose has been shown to be safe and effective in preventing this potentially life-threatening condition, as supported by the most recent guidelines 1.

Administration

• The intramuscular injection is the preferred route of administration due to its higher efficacy and reliability compared to oral supplementation.
• The oral regimen may be considered for parents who decline the injection, but it requires careful adherence to the recommended dosing schedule.

Evidence

• The recommended dose of 1 mg of vitamin K1 is based on the most recent and highest quality study available 1, which provides strong evidence for its safety and efficacy in preventing VKDB.
• Other studies, such as 1, 1, 1, and 1, also support the importance of vitamin K supplementation in newborns, but the most recent guideline 1 takes precedence in informing clinical practice.

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 recommended dose of vitamin K for term newborns is 0.5 mg to 1.0 mg, administered intramuscularly (IM) at birth 3.
• This dose is effective in preventing vitamin K deficiency bleeding (VKDB) in term newborns 4, 5, 3.
• Oral vitamin K administration is also an option, but it requires multiple doses and has a lower efficacy compared to IM administration 5, 3.
• The Canadian Paediatric Society and the College of Family Physicians of Canada recommend routine IM administration of a single dose of vitamin K at 0.5 mg to 1.0 mg to all newborns 3.
• For parents who decline IM vitamin K, oral vitamin K (2.0 mg at birth, repeated at 2 to 4 and 6 to 8 weeks of age) can be administered, but healthcare providers should inform them of the increased risk of VKDB with this regimen 3.

Comparison of Different Doses

• A study comparing 0.5 mg and 1 mg of vitamin K in premature infants found that both doses were effective in preventing hemorrhagic disease of the newborn, but 0.5 mg may be more than adequate 6.
• The same study suggested that 0.3 mg/kg may be used for babies with birth weights below 1000 g 6.

Administration Routes

• Intramuscular administration is the most effective route for vitamin K prophylaxis in term newborns 4, 5, 3.
• Oral administration is an alternative, but it requires multiple doses and has a lower efficacy compared to IM administration 5, 3.
• Intravenous administration is not recommended as a routine method for vitamin K prophylaxis in term newborns 3.