The American Academy of Pediatrics (AAP) released an updated policy statement reinforcing the benefits of administering vitamin K to newborns shortly after birth to prevent potentially life-threatening late-onset vitamin K deficiency bleeding (VKDB).1 The reasons behind these prophylaxis refusals are complex, pediatric experts explain.

“Vitamin K deficiency bleeding was thought to be a problem of the past but has recently returned to the spotlight due to increased numbers of refusal after birth,” said Cristy Toburen, CPNP, National Association of Pediatric Nurse Practitioners, Newborn Special Interest Group Chair.

As a CPNP, Toburen has witnessed the rising rates of vitamin K refusal at birth along with a resultant increase in cases of VKDB. While the condition is relatively rare, Toburen cited a cluster of VKDB cases that occurred in Tennessee in infants not given vitamin K prophylaxis.2,3


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One reason for refusal can be traced back to a single study from 1990 suggesting a link between vitamin K administration and childhood cancer, an association that has not been borne out in subsequent larger studies. Other factors linked to refusal include lack of understanding of the indication for vitamin K, concern about injection site pain, and concern related to the preservative in the formulation. A preservative-free formulation is available and no evidence has linked the preservative (benzyl alcohol) to toxicity, according to the AAP.

“I think the reason for refusal is multifactorial, at least at our hospital,” said Teresa A. Kilkenny, DNP, CPNP-PC, National Association of Pediatric Nurse Practitioners Newborn Special Interest Group Secretary. “Years ago, I don’t think I had a vitamin K refusal. We used to have parents opt-out, and if they didn’t say anything, infants received erythromycin eye ointment (EEM) and vitamin K; we always asked for parental consent for hepatitis B immunization. In the last 10 years, we started telling parents we were going to give vitamin K and EEM and now have had some parents start to refuse them.” She added that many parents refusing these preventive care options use Google as a source of information.  

Refusal of vitamin K is also often correlated with refusal of other preventive care modalities in infants such as hepatitis B vaccination, Toburen said.

“Unfortunately, many people have less trust in the medical system,” Toburen said. “Families sometimes worry that there may be complications that health care providers are unaware of or that are being purposefully overlooked. This along with the large amounts of misinformation all over the internet and social media makes it very confusing for [parents] to make truly educated decisions about health care services for themselves or their child.” 

“We need to continue to have open communication WITH patients, and not AT patients,” said Toburen. “We need them to share with us their concerns so that we can address them properly. Patients and health care providers need to develop a partnership so that trust can develop and shared decision making can take place.”

Strategies for Parent Education

“It is important for NPs and PAs to validate parental concerns and mention specific reasons that put their infant at risk of VKDB such as exclusive breastfeeding,” Toburen said. Sufficient levels of vitamin K are not transferred through the placenta or in breast milk, regardless of maternal intake, Toburen explained. At birth, newborns have reduced stores of vitamin K levels.

Parental education should include the known risks of intramuscular (IM) vitamin K prophylaxis, which are limited to pain at the injection site, mild soreness, and a theoretical risk of infection as with any injection. “Some families that refuse IM vitamin K injection are willing to administer it orally, but research shows us this is not as effective. Additionally, oral vitamin K is not licensed for use in the US for prevention of VKDB,” Toburen explained.

“It is important that parents know that we care and want them to have the most accurate information to keep their baby healthy,” Toburen noted. “We need to present the facts in clear terms they understand and provide additional resources/handouts for them to review and consider the decision they are making.”

“We have the parents sign a form when they refuse vitamin K that talks about all of the risks,” including the short-term risk of hemorrhage and long-term risk of intracranial bleeding, Dr Kilkenny said. “We discuss the unpredictable absorption of oral vitamin K since some parents request that option.”

Causes of Vitamin K Deficiency Bleeding

Vitamin K deficiency bleeding is characterized by its time of presentation: early-onset, classic, or late-onset. Early-onset VKDB begins within a baby’s first 24 hours of life, typically to those whose mothers are taking medications such as anticonvulsants, antibiotics, antituberculosis agents, and warfarin, which can affect vitamin K absorption. Infants may show signs of the disease through bruising or life-threatening intracranial hemorrhage.

Classic vitamin K deficiency bleeding typically occurs between 2 days and 1 week of life. Late-onset presentation of the disease is most often seen between 2 and 8 weeks but can also be diagnosed as late as 6 months. Late-onset VKDB is usually associated with exclusively breastfed infants who did not receive vitamin K prophylaxis at birth and can result in a number of complications such as liver dysfunction and intracranial bleeding.

Table. American Academy of Pediatrics Recommendations on Vitamin K in Newborns

Vitamin K should be administered to all newborn infants weighing >1500 g as a single, intramuscular dose of 1 mg within 6 hours of birth
Preterm infants weighing ≤1500 g should receive a vitamin K dose of 0.3 mg/kg to 0.5 mg/kg as a single, intramuscular dose
Pediatricians and other health care providers must be aware of the benefits of vitamin K administration as well as the risks of refusal and educate caregivers on this information
Consider vitamin K deficiency bleeding when evaluating bleeding in the first 6 months of life, even in infants who received prophylaxis, and especially in exclusively breastfed infants
Source: Hand et al.1

“This illness is relatively rare in the United States today because we have offered this dose of vitamin K to infants,” said coauthor Ivan Hand, MD, FAAP.4 “This bleeding disease can be devastating and is totally preventable, and so we urge parents to ask questions if they have concerns.”

“We understand parents want the best for their children, and we, as pediatricians, share that goal,” Dr Hand said.4 “We strongly recommend that parents bring their questions to us and help us understand any concerns.”

Fact sheets for parents on the importance of vitamin K for newborns are available from the Centers for Disease Control and Prevention. The AAP also provided talking points for clinicians.

References

1. Hand I, Noble L, Abrams SA. Vitamin K and the newborn infant. Pediatrics. 2022;149(3):e2021056036. doi: 10.1542/peds.2021-056036

2. Schulte R, Jordan LC, Morad A, Naftel RP, Wellons JC 3rd, Sidonio R. Rise in late onset vitamin K deficiency bleeding in young infants because of omission or refusal of prophylaxis at birth. Pediatr Neurol. 2014;50(6):564-8. doi:10.1016/j.pediatrneurol.2014.02.013

3. Centers for Disease Control and Prevention. Notes from the field: late vitamin K deficiency bleeding in infants whose parents declined vitamin K prophylaxis–Tennessee, 2013. MMWR Morb Mortal Wkly Rep. 2013;62(45):901-902.

4. American Academy of Pediatrics Policy Statement: Newborns Require Vitamin K Shortly After Birth to Prevent Bleeding Disease. News release. American Academy of Pediatrics. February 22, 2022. Accessed March 1, 2022. https://www.aap.org/en/news-room/news-releases/aap/2022/american-academy-of-pediatrics-policy-statement-newborns-require-vitamin-k-shortly-after-birth-to-prevent-bleeding-disease/