Making an Informed Decision on Vitamin K Prophylaxis

by Donna Walls, RN, BSN, IBCLC, ANLC

In 1961, the American Academy of Pediatrics 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 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 formation of coagulation factors, preventing abnormal or excessive bleeding. Infants are at increased risk for VKDB until they are regularly eating vitamin K-containing foods (dark green leafy vegetables), usually at 6 months of age, and their intestinal bacteria start producing vitamin K.

At birth, babies have only a small amount of vitamin K stored in their bodies (very little passes to the fetus from the mother during pregnancy) and breastmilk contains low amounts of the vitamin. Formula does provide more vitamin K than breastmilk, making exclusively breastfed infants more at risk than formula fed infants for VKDB. Knowing that exclusive breastfeeding is the gold standard for infant feeding, how can this deficiency make sense? It is theorized that Infants are at risk for VKDB until they are about six months old. This bleeding condition presents as early, classical, or late.

Early VKDB occurs in 1 in 60 to 1 in 250 newborns and late VKDB is more rare, occurring in 1 in 14,000 to 1 in 25,000 infants. Early presents in the first 24 hours, is severe and found more frequently in mothers requiring anti-seizure medications, some antibiotics, anticoagulants or isoniazid for tuberculosis treatment. Classical presents in1-7 days as bruising and bleeding from the umbilical cord or the circumcision incision. Late occurs in 2-12 weeks, is rare and presents as bleeding in the brain or intestines. Infants who do not receive a vitamin K shot 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. For darker skinned babies, the gums may appear pale
  • After the first 3 weeks of life, the white parts of your baby’s eyes may turn yellow
  • Stool that has blood in it, is black, or dark and sticky (also called ‘tarry’), or vomiting blood
  • Irritability, seizures, excessive sleepiness, or a lot of vomiting may all be signs of bleeding in the brain

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

The American Academy of Pediatrics (AAP) Policy Statement:

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

There have been some controversies surrounding the routine administration of newborn Vitamin K. Studies out of the United Kingdom have shown an increase of parents refusing the vitamin K injection, raising concerns with newborn care providers. (Warren, 2013)

These 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. Research in the early 1990s suggesting there was a correlation between vitamin K injection and childhood cancers

Recent research from the USA and around the world does not support any correlation between the vitamin K shot and the development of childhood cancers including leukemia or solid tumors. There has only been 1 documented case of allergic reaction and additives have been minimized or removed from the injection solution. A “preservative-free” formulation is available if parents request it. As far as concerns regarding pain, we recommend cuddling, skin to skin and breastfeeding before, during and after the injection. There are some reported cases of redness or irritation at the injection site but these have been shown to be mild and temporary.

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).

There also seems to be a persistent controversy regarding the routes of administration and their efficacy. Many parents who have voiced a 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 probably 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 is should be given with a feeding and assure that the medication is not spit up.

“Between the two routes of administration of vitamin K, 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”. (Sankar, 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 multidose regimen is of concern. (Sutor, 1999).

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 does appear that the risks of Vitamin K Deficiency Bleeding are greater than the risks of the intramuscular vitamin K injection. For those parents who prefer the multidose oral prophylaxis there needs to be the development of a system that can assure completion of the regimen. 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

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/

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

Lehmann, J. Vitamin K as a Prophylactic in 13,000 infants. 1944.  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 https://doi.org/10.1542/peds.2017-3743

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

Pediatrics 2003;112;191 Committee on Fetus and Newborn Controversies Concerning Vitamin K and the Newborn

https://pediatrics.aappublications.org/content/pediatrics/112/1/191.full.pdf

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.