Making an Informed Decision on Vitamin K Prophylaxis

By Donna Walls, RN, BSN, IBCLC, ANLC
With introduction and contributions by Jess Fedenia 

Source: United States Breastfeeding Committee.

The concept of shared decision making is based on the tenets that patient autonomy is an ethical imperative, and several important outcomes of care are improved when individuals feel involved in their own health care decisions. 2,3 However, shared decision making can be misconstrued and therefore misused.

I bought cream for the first time in my three decades on Earth in an attempt to calm the bulging bags under my eyes. I slabbed on the ointment, wondering why in the world I felt and looked so tired. 

Soon after, I learned about a phenomenon called decision fatigue and it all started to make sense. 

Annie Reneau explains it this way in her Scary Mommy piece:

“There is a commonly overlooked stressor in childrearing…It’s a well-known psychological phenomenon, and I’m not sure why we don’t talk about it more in parenting circles… We usually think of having choices as a good thing, but making decisions zaps our mental and emotional energy. Even small decisions, such as what to wear or what to have for dinner, require our conscious attention and thought. Every time we make a choice, we go through a process of weighing pros and cons, risks and benefits, costs and rewards. Our brains go through that process even if we aren’t cognizant of it, and the energy expenditure occurs whether we want it to or not. More decisions mean more drained energy and lowered willpower.” 

Adding to parents’ choices, COVID-times have exasperated the fatigue . On top of the normal slew, now we wonder about things like if it’s safe to leave the house, if we should send our kids to in-person classes, if we should get the vaccine, and so on. 

Healthy Children Project’s Donna Walls, RN, BSN, IBCLC, ANLC has prepared an article about making an informed decision on vitamin K prophylaxis providing us with historical and scientific context. To add personal perspective, I’ve peppered in my experience on choosing the vitamin k injection for my three children.

Historical insight into vitamin K administration 

Photo by Jonelle Yankovich on Unsplash

In 1961 the American Academy of Pediatrics (AAP) began recommending all newborns receive a vitamin K injection as part of routine newborn care. The recommendation was made after review of research which confirmed the administration of vitamin K as an effective preventative treatment for the condition called vitamin K deficiency bleeding (VKDB). 

Historically, in 1894 Dr. Townsend of Boston first described 50 cases of bleeding in newborns which he called “Haemorrhagic Disease of the Newborn (HDN).” Then, in 1930, a Danish biochemist, Carl Peter Henrik Dam, discovered that vitamin K deficiency was the cause of unexpected bleeding in baby chicks, for which he won a Nobel Prize. In 1944 Jorge Lehmann, a Swedish researcher studied 13,000 infants who were given 0.5 mg of vitamin K (either oral or injection) on the first day of life. The published research confirmed that infants who received vitamin K experienced a 5-fold reduction in the risk of bleeding to death during the first week of life. It was estimated that for every 100,000 full-term infants, vitamin K would save the lives of 160 infants per year (Lehmann 1944).

Vitamin K is a co-factor which plays an important role in the formation of coagulation (blood clotting) factors, reducing the risk of abnormal or excessive bleeding. Infants are at increased risk for VKDB until they are regularly eating vitamin K-containing foods (e.g. dark green leafy vegetables, broccoli, brussel sprouts, cashews, kidney beans), usually at 6 months of age, and until their intestinal bacteria start producing vitamin K.  At birth, babies have only a small amount of vitamin K stored in their bodies as very little passes to the fetus from the mother during pregnancy, and breastmilk contains low amounts of the vitamin. Formula provides more vitamin K than breastmilk, making VKDB risk greater in  exclusively breastfed infants than for formula fed infants. 

Exclusive breastfeeding is considered the gold standard of infant feeding, so how can we make sense of this apparent deficiency?  It is theorized that similar to the digestive and immune systems, the coagulation mechanisms will naturally mature during the first months of life. (Dekker, 2019)

Breaking down Vitamin K Deficiency Bleeding

VKDB presents as early, classical or late.  

Early VKDB:

  • occurs in 1 in 60 to 1 in 250 newborns.
  • presents in the first 24 hours of life.
  • is severe and found more frequently in mothers requiring anti-seizure medications, some antibiotics, anticoagulants or isoniazid for tuberculosis treatment.

Late VKDB:

  • is rarer occurring in 1 in 14,000 to 1 in 25,000 infants.
  • occurs within two to 12 weeks and presents as bleeding in the brain or intestines.

Classical VKBD:

  • presents in one to 7 days as bruising and bleeding from the umbilical cord or the circumcision incision. 

Infants who do not receive a vitamin K injection at birth are 81 times more likely to develop late VKDB.  (CDC Fact Sheet)

Infants may develop any of the following signs of VKDB: bruises, especially around the baby’s head and face, bleeding from the nose or umbilical cord, skin color that is paler than before.  InBabies of Color, gums may appear pale.

After the first three weeks of life, the sclera (white part of the baby’s eyes) may turn yellow.

Stool may have blood in it or appear black or dark and sticky (also called ‘tarry’). Babies may also vomit blood.  

Irritability, seizures, excessive sleepiness, or a lot of vomiting may also all be signs of bleeding in the brain.

If or when any of these symptoms are recognized, parents should call their infant’s healthcare provider immediately.

The AAP provides their policy statement on vitamin K injection which reads as follows:

“Because parenteral vitamin K has been shown to prevent VKDB of the newborn and young infant and the risks of cancer have been unproven, the American Academy of Pediatrics recommends the following:

  1. Vitamin K1 should be given to all newborns as a single, intramuscular dose of 0.5 to 1 mg.
  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.

  1. 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 newborns who are breastfed exclusively.” (AAP, 2003)

Jess’s experience:

Like many of the decisions I made with my first child, we opted for the vitamin K injection, because that’s “what ya do.” Willow was born in a large hospital, and while I was very firm on wanting a non-medicated, vaginal birth and breastfeeding soon after, the other choices I left up to whatever the hospital’s norm was. That meant Willow got the vitamin K injection, Hep B vaccine, and antibiotic eye ointment by default. Looking back, I wonder if my non-decisions had something to do with decision fatigue. 

“The more choices you make throughout the day, the harder each one becomes for your brain, and eventually it looks for shortcuts…the ultimate energy saver: do nothing. Instead of agonizing over decisions, avoid any choice,” author John Tierney writes in this piece.

I was a young mom, fresh out of an undergraduate program and internship. My decision-making capacity may have been maxed out.  

Rejection of and concerns over vitamin K injections in newborns 

Photo by Sergiu Vălenaș on Unsplash

There have been some controversies surrounding the routine administration of newborn vitamin K. 

A growing number of parents in the United States refuse the vitamin K injection for their newborns raising concerns among care providers.  (Loyal, 2017

Reasons for refusal include:

  1. Concern about causing pain in their newborn
  2. Concerns about the ingredients in the vitamin K injection solution (preservatives and other additives)
  3. Concerns about possible allergic reactions. 
  4. Perception that vitamin K injection may cause childhood cancers (Golding, et al, 1992)  There is ample research to quell parents concerns. For instance, research  does not support any correlation between the vitamin K shot and the development of childhood cancers including leukemia or solid tumors. 

Only one case of allergic reaction has been reported and that was with an intravenous injection. 

Additives have been minimized ( e.g. propylene glycol was reduced by 30X the previously used dose) or removed from the injection solution. A “preservative-free” formulation is also available upon request. In order to diminish pain during the time of the injection, cuddling, skin-to-skin, and breastfeeding before, during and after the injection are all effective ways to manage the infant’s pain. If the mother is unavailable, a cloth with the maternal skin and milk aroma can be made available for the newborn to inhale.   There are some reported cases of redness or irritation at the injection site but these have been shown to be mild and temporary.

Jess’s experience:

When I became pregnant with my second child, I opted for a home birth with midwifery care. I felt in charge of my perinatal care and therefore more involved in every aspect of decision-making.

Before I found out the sex of my baby, my husband and I debated vehemently over circumcising our potenitally-male child. 

Researching male circumcision led me to research the vitamin K injection. Dekker’s Evidence Based Birth website was an awesome resource, and although we didn’t need to make a decision about male circumcision because Iris was born with female parts, I could make an informed decision to opt for the vitamin K injection. 

I had considered oral administration (more on that later) for my second baby to avoid an injection, but worried that with a toddler and a new baby,  I wouldn’t be able to keep up with the demand of multiple doses. I also worried about the efficacy if spit up. 

Ultimately, the injection didn’t seem to cause any discomfort; Iris and I laid skin-to-skin and she breastfed while our midwife administered the injection. 

When my son was born, we also opted for the vitamin K injection, mostly because I knew I would breastfeed him leaving him at risk for developing VKDB.   

Increasing Vitamin K through maternal diet 

Source: United States Breastfeeding Committee.

Can eating more vitamin K-containing foods or supplements during pregnancy or breastfeeding increase vitamin K levels in the newborn? In a 2018 systematic review and meta-analysis, researchers pooled six randomized trials (over 21,000 pregnant people) from the US, the United Kingdom (UK), the Netherlands, and Japan. This review found no difference in newborn bleeding with vitamin K supplementation, but there was improvement in maternal vitamin K levels, including in breast milk, and levels in newborn cord blood. (Shahrook et al. 2018)

Injection vs. oral administration 

Many parents who have voiced concern about causing pain in the newborn have opted for the oral route of administration. 

The 3-dose, 2 mg regimen of oral Vitamin K1 does lower the chance of VKDB to less than 1 in 100,000 births, but does not eliminate it as effectively as the injection (Mihatsch et al. 2016). If the weekly oral vitamin K regimen is used, because it is a fat- soluble vitamin, it should be given with a feeding and must not be spit up in order to be effective .

Sankar found that “Between the two routes of administration of vitamin K, [intramuscular](IM) route was found to be more beneficial than the oral route in the two studies from Germany and the United Kingdom. The reported RRs for IM and oral routes were 0.03 and 0.2, respectively, in the former study and 0.01 and 0.35, respectively, in the latter study. The disadvantage of oral vitamin K may possibly be due to poor absorption and a shorter duration of effect. Indeed, multiple oral doses of vitamin K seemed to offer an advantage over a single oral dose”. (2016) 

There has been improved efficacy demonstrated with multiple doses of vitamin K, but it does require repeated doses. Worldwide, the process of tracking and contacting discharged parents for completion of the multi dose regimen is of concern. (Sutor, 1999)

Weighing the risk and benefit 

As healthcare providers and parents, we all must consider the risks and benefits of any and all treatments and care protocols for our children. From an evidence-based approach, it appears  that the risks of VKDB  are greater than the risks of the intramuscular vitamin K injection. For those parents who prefer the multi dose oral prophylaxis, a system that assures completion of the regimen must be in place.  Effective, open and honest communication between parents and their infant’s care provider is essential for all informed decision-making and the vitamin K decision is no exception.

 

References

Afanasjeva, J. Administration of Injectable Vitamin K Orally. Hosp Pharm. 2017 Oct; 52(9): 645–649.

Published online 2017 Sep 8. doi: 10.1177/0018578717729663

Ardell, S. et al. Prophylactic vitamin K for the prevention of vitamin K deficiency bleeding in preterm neonates. Cochrane Database of Systematic Reviews. 2018;https://doi.org/10.1002/14651858.CD008342.pub2

CDC National Center on Birth Defects and Developmental Disabilities.  Protect Babies from Life-Threatening Bleeding — Talk to Expectant Parents about the Benefits of Vitamin K Shot for Newborns. n.d. https://www.cdc.gov/ncbddd/blooddisorders/documents/Vitamin-K-Provider-p.pdf

Committee on Fetus and Newborn Controversies concerning vitamin K and the newborn. Pediatrics. 2003; 112: 191-192 

Dekker, R. Evidence on: The Vitamin K Shot in Newborns. 2019. https://evidencebasedbirth.com/evidence-for-the-vitamin-k-shot-in-newborns/

Golding, J. et al.  Childhood cancer, intramuscular vitamin K, and pethidine given during labor. BMJ.1992; 305:341-346.

Lehmann, J. Vitamin K as a Prophylactic in 13,000 infants. Lancet. 1944. 243(6294): 493-494.  https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(00)74175-4/fulltext

Lowensteyn, Y. Increasing the dose of oral vitamin K prophylaxis and its effect on bleeding risk. European Journal of Pediatrics. 2019; 178: 1033-1042 https://doi.org/10.1007/s00431-019-03391-y

Loyal, J. Factors associated with refusal of intramuscular vitamin K in normal newborns. Pediatrics. 2018; 142: 1-6

Mihatsch WA,  ESPGHAN Committee on Nutrition, et al. Prevention of Vitamin K deficiency bleeding in newborn infants: a position paper by the ESPGHAN committee on nutrition. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):123–9. https://doi.org/10.1097/MPG.0000000000001232.

National Center on Birth Defects and Developmental Disabilities, CDC. Vitamin K deficiency bleeding. December, 2019

https://www.cdc.gov/ncbddd/vitamink/facts.html

Sankar, M.J. et al. Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. J Perinatol. 2016 May; 36(Suppl 1): S29–S35.Published online 2016 Apr 25. doi: 10.1038/jp.2016.30

Simes, D.C, Vitamin K as a Diet Supplement with Impact in Human Health: Current Evidence in Age-Related Diseases Nutrients. 2020 Jan; 12(1): 138. Published online 2020 Jan 3. doi: 10.3390/nu12010138

Stachowiak, A.  and Furman, L. Vitamin K Is Necessary for Newborns. Pediatrics in Review June 2020, 41 (6) 305-306; DOI: https://doi.org/10.1542/pir.2019-0146

Sutor AH, von Kries R, Cornelissen EA, McNinch AW, Andrew M. Vitamin K deficiency bleeding (VKDB) in infancy. ISTH Pediatric/Perinatal Subcommittee. International Society on Thrombosis and Haemostasis. Thromb Haemost 1999; 81(3): 456–461.

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