As a healthcare provider, I sometimes struggle to understand the choices parents make, especially when they decide against evidence-based medical treatments that could prevent serious risks to their child’s health. I wish parents could see through the provider's eyes the potentially devastating outcomes that can result from opting out of what we consider straightforward, science-based interventions. It's true that, in most cases, a child might be okay. But what if they're not? Are you willing to take that risk when the consequences can be so severe?

Over time, routine treatments like the Vitamin K shot at birth can seem less important because they're so effective at what they do—they prevent serious complications. The same can be said about vaccines. Today’s parents haven't witnessed the impact of diseases like measles, mumps, or smallpox the way parents did in the 1960s and prior. Back then, when vaccines offered hope against these devastating illnesses, parents were eager to protect their children. Now, with the flood of misinformation on social media and the lack of firsthand experience with the diseases these vaccines prevent, it's no wonder parents find it challenging to make the right healthcare decisions for their children.

What is Vitamin K and what is it's purpose?

Vitamin K is a fat-soluble vitamin essential for blood clotting, named after the German word for clotting—Koagulation. Our bodies can't produce Vitamin K on their own, nor do we store it well, so we must get it from our diet. There are two primary forms of Vitamin K. The first is Vitamin K1 (phylloquinone), found in leafy green vegetables such as spinach, kale, Swiss chard and collards; and also in broccoli, cabbage, cauliflower, avocado, banana and kiwi; to name a few. The other is Vitamin K2 (menaquinone), produced by bacteria in our intestines. Vitamin K1 from plant sources contributes the most to our overall Vitamin K levels, while Vitamin K2 from intestinal bacteria plays a smaller role.

Vitamin K is crucial for activating certain molecules, known as clotting factors, that help the blood to clot. While these clotting factors are present at normal levels at birth, they aren’t fully activated due to the naturally low levels of Vitamin K in newborns. Without sufficient Vitamin K, the body can't activate these clotting factors, leading to an impaired ability to form blood clots.

Generally, our bodies can manage with lower levels of Vitamin K without any immediate issues. However, if these levels drop too low, we risk reaching a point where the body can no longer clot blood effectively, leading to spontaneous bleeding. The threshold at which bleeding occurs can vary from person to person, making it unpredictable and potentially dangerous.

So, if it's normal for Vitamin K to be low in newborns, isn't this natural, why would we need to intervene?

A baby who doesn’t have enough Vitamin K can start to bleed suddenly and without warning. This condition is known as Vitamin K Deficiency Bleeding (VKDB). VKDB can be classified into two main types:

1. Idiopathic VKDB: The cause is unknown. Almost all cases occur in babies who are exclusively breastfed.
2. Secondary VKDB: This type occurs when a baby has an underlying condition such as gallbladder disease, cystic fibrosis, or is experiencing side effects from certain medications. Most babies with secondary VKDB are also exclusively breastfed.

VKDB can present in three patterns based on the timing of onset:

• Early VKDB: Occurs within the first 24 hours of life and is usually seen in babies whose mothers took medications that interfere with Vitamin K (such as warfarin, seizure medications, or tuberculosis medications). Bleeding typically occurs in the skin, brain, and abdomen.
• Classical VKDB: Appears between days 2-7 of life, most commonly on days 2-3 when Vitamin K levels are at their lowest. Common bleeding sites include the gastrointestinal tract, umbilical cord site, skin, nose, and circumcision site. Although the official cause is listed as “unknown,” risk factors include exclusive breastfeeding and inadequate feeding (less than 100 mL or 3.4 ounces of milk per day).
• Late VKDB: Develops after the first week of life, typically between weeks 3-8, but can occur anytime within the first 6 months. Bleeding often happens in the brain, skin, and gastrointestinal tract, with brain bleeding frequently being the first sign. Late VKDB is most common in exclusively breastfed infants who did not receive a Vitamin K shot and may be exacerbated by conditions like undetected gallbladder disease, cystic fibrosis, chronic diarrhea, or antibiotic use.

Late VKDB is rare when you look at the numbers, but its consequences can be devastating. More than half of infants who develop late VKDB will experience bleeding in the brain. One of the most alarming aspects of VKDB is that it often goes unnoticed until it's too late. Infants can't communicate what they're feeling, and the symptoms of a brain bleed can be very subtle—such as difficulty feeding, lethargy, or increased fussiness. Unfortunately, a brain bleed can grow to a critical size before parents realize something is seriously wrong. And even after parents seek help, it can take additional time for healthcare professionals to diagnose the issue accurately.

When infants are born, many of their bodily systems, like the nervous and immune systems, are still maturing. It’s possible that an infant’s clotting system also requires time to develop fully. There may be reasons we don’t yet understand that result in low transmission of Vitamin K from mother to baby before and after birth. For instance, there could be an unknown beneficial mechanism that prevents certain environmental toxins from reaching the baby—one that also has the side effect of limiting the amount of Vitamin K that reaches the baby through the placenta and breast milk.

However, it might not really matter why babies are born with low levels of Vitamin K. The critical point is that they are, and without supplemental Vitamin K at birth, some babies will suffer from Vitamin K deficiency bleeding. While most will not experience bleeding, some will, and for those affected, the consequences can include brain injury or even death. The vast majority of these injuries and fatalities are preventable with the simple administration of Vitamin K at birth.

Historical Timeline behind Vitamin K use

The importance of Vitamin K for newborns has been recognized for over a century:

• 1894: Dr. Townsend, a Boston physician, described 50 cases of newborn bleeding, termed “Haemorrhagic Disease of the Newborn (HDN).” He was the first to link this condition to inadequate breastfeeding.
• 1930: A Danish biochemist discovered that Vitamin K deficiency was causing unexpected bleeding in baby chicks, indicating its crucial role in blood clotting.
• 1944: A landmark Swedish study involving more than 13,000 infants demonstrated a significant reduction in the risk of bleeding to death during the first week of life when 0.5 mg of Vitamin K was administered (either orally or by injection). The study estimated that for every 100,000 full-term infants born, Vitamin K could save the lives of 160 infants annually.
• 1961: After nearly two decades of supporting research, the American Academy of Pediatrics recommended routine Vitamin K shots for newborns, establishing this as the standard of care in the U.S.
• 1999: The term “Haemorrhagic Disease of the Newborn (HDN)” was updated to “Vitamin K Deficiency Bleeding (VKDB)” to more accurately reflect that the condition is solely due to Vitamin K deficiency and can occur later in infancy, beyond the newborn period.

If we think back to conversations with our grandparents, or even great-grandparents, it wasn’t uncommon to hear about the loss of a newborn. However, with advances in science and modern medicine, many of these once-common tragedies have become preventable. Today, it's much rarer to hear of a full-term infant loss, thanks to these medical advancements.

Now let's debunk some Myths!

• Propylene glycol causes seizures! What about allergic reactions or side effects? Or worse yet PRESERVATIVES?

Some parents are concerned about the use of propylene glycol in the Vitamin K shot. However, propylene glycol is commonly used in many medications—whether oral, topical, or injectable—because it is highly effective at helping medications dissolve into liquid form. The severe side effects associated with propylene glycol date back decades and were linked to very high doses, not the small amount used in the Vitamin K shot.

Regarding allergic reactions to the Vitamin K shot, almost all historical cases occurred with the intravenous (IV) form. The IV form is never used in the newborn period unless an infant is already presenting with Vitamin K deficiency bleeding.

Side effects from the Vitamin K injection given at birth are extremely rare. When they do occur, they are often so uncommon that they are documented as case reports.

• I heard there were risks to my child getting leukemia by getting Vitamin K injections.

What sparked such a concern?

In the early 1990's, a British newspaper reported that researchers had discovered a potential link between Vitamin K injections and childhood leukemia. This report caused a significant shift in Great Britain from using Vitamin K shots to opting for oral Vitamin K, leading to a surge of research aimed at determining whether the injectable form was indeed linked to cancer.

Over the next two decades, numerous studies were conducted to explore the relationship between injectable Vitamin K and leukemia. In 1999, the World Health Organization (WHO) convened a working group to investigate this issue further. After thoroughly reviewing the available evidence, they concluded that there was insufficient evidence to support a link between Vitamin K injections and childhood cancer.

In the early 2000s, researchers in the U.S. analyzed data from several major studies involving children with and without cancer. Their findings showed no association between injectable Vitamin K and any type of childhood cancer. Around the same time, British researchers conducted the most comprehensive study to date, which also concluded that there was no convincing evidence that neonatal Vitamin K administration influences the risk of children developing leukemia or any other cancer.

After 24 years of extensive research, experts have reached a consensus; there is no evidence to support a link between Vitamin K injections and leukemia or other childhood cancers.

Why are parents still not convinced?

The problem lies in the persistent spread of misinformation, particularly on social media. Social media platforms have made some parents less likely to trust healthcare providers and more inclined to believe misinformation shared through the opinions of peers.

• Isn't Vitamin K in Oral form is just as effective; why does my child need a shot?

Well, let's look at the Pros and Cons of each:

Vitamin K Shot

Pros:

• Highly effective at preventing classical and late VKDB.
• Vitamin K is slowly released over time from the injection site, providing enough Vitamin K1 until the baby’s levels reach those of an adult naturally.

Cons:

• Causes pain, which can be minimized by having the infant breastfeed during the shot.
• Can cause bleeding or bruising at the injection site.
• May not protect a baby with undetected gallbladder or liver disease from VKDB.

Oral Vitamin K

Pros:

• Easy to administer and non-invasive (pain-free).
• The 3-dose regimen of 2 mg Vitamin K1 reduces the risk of classical and late VKDB to under 1 per 100,000, though it may not be as effective as the injection, which has incidence rates closer to zero.
• The weekly regimen appears to protect infants with undiagnosed gallbladder issues as effectively as the shot. However, the 3-dose regimen of 2 mg Vitamin K1 has not been tested in this high-risk group.

Cons:

• Some infants may not absorb it well (e.g., those with diarrheal illness), or they may spit it up.
• For babies with undetected gallbladder or liver disease, a 3-dose regimen of oral Vitamin K may not be as protective as the shot.
• The 3-dose regimen of 1 mg oral Vitamin K1 is less effective than the shot at preventing late VKDB; data from some countries suggest that even the 3-dose regimen of 2 mg oral Vitamin K1 might be less effective, although the difference may not be significant (Mihatsch et al., 2016).
• Requires parents to commit to giving at least three doses or weekly doses.

The American Academy of Pediatrics recommends:

1. All newborns should receive a single, intramuscular dose of 0.5 to 1 mg of Vitamin K1.
2. Additional research should be conducted on the efficacy, safety, and bioavailability of oral formulations and optimal dosing regimens of Vitamin K to prevent late VKDB.
3. Health care professionals should promote awareness among families of the risks of late VKDB associated with inadequate Vitamin K prophylaxis from current oral dosage regimens, particularly for exclusively breastfed newborns.

The Centers for Disease Control (CDC) states: "A vitamin K shot can be administered after the first feeding at the breast, but not later than 6 hours of age. An oral dose of vitamin K is not recommended."

Why is the Vitamin K shot preferred in US over Oral?

The Vitamin K1 injection, administered intramuscularly (IM), is the preferred method in the U.S. for several reasons. First, there is no proven oral version of Vitamin K specifically designed for infants available in the United States. Additionally, the injection is absorbed more effectively than the oral version and has a delayed release effect that provides protection against both classical and late Vitamin K Deficiency Bleeding (VKDB). The risk of late VKDB is nearly zero with the injection, although it does not completely eliminate the risk for infants with underlying liver or gallbladder disorders. While a 3-dose regimen of 2 mg oral Vitamin K1 also reduces the risk of VKDB to less than 1 in 100,000 births, it may not be as effective as the injection. Infants with underlying, often undetected, gallbladder or liver disorders may not absorb oral Vitamin K adequately when given in a 3-dose regimen. In other countries, the oral version of Vitamin K is more commonly used because mothers and infants typically receive home visits from nurses. This type of home care is not routinely provided in the U.S., so parents must remember to administer follow-up doses, and someone must ensure the infant does not spit it up. The oral Vitamin K regimen requires at least three doses—at birth, 4 to 6 days, and 4 to 6 weeks—and breakthrough cases of VKDB are often associated with missing the final dose.

• My child had a nontraumatic birth and we did delayed cord clamping...

The most significant risk factors for Vitamin K Deficiency Bleeding (VKDB) are exclusive breastfeeding and not receiving enough Vitamin K after birth. Evidence does not support the claim that birth trauma contributes to VKDB, and the timing of cord clamping likely has no effect, as Vitamin K is typically undetectable in cord blood.

Final Thoughts

As a healthcare provider, it's natural to feel frustrated when parents opt out of proven treatments. However, understanding their fears and concerns and providing clear, evidence-based information can help guide them toward making informed decisions. It’s crucial to communicate that while most newborns might be okay without the Vitamin K shot, the risk is not worth taking when a safe, effective preventive measure is available.

Education and empathy are key in bridging the gap between healthcare providers and parents, ensuring that every child has the best start in life.

What are your thoughts as parents on Vitamin K?

Can I answer any questions for you that I haven't addressed above?

Are there any added thoughts from other providers?