Title: Vitamin K for the Prevention of Vitamin K Deficiency Bleeding (VKDB) in Newborns Approval Date: Pages: NEONATAL CLINICAL February 2018 1 of 3 Approved by: Supercedes: PRACTICE GUIDELINE Neonatal Patient Care Teams, HSC & SBH SBH #98 Women’s Health Maternal/Newborn Committee Child Health Standards Committee

1.0 PURPOSE

1.1 To ensure all newborns are properly screened for the appropriate Vitamin K dose and route of administration and managed accordingly.

Note: All recommendations are approximate guidelines only and practitioners must take in to account individual patient characteristics and situation. Concerns regarding appropriate treatment must be discussed with the attending neonatologist.

2.0 PRACTICE OUTCOME

2.1 To reduce the risk of Vitamin K deficiency bleeding.

3.0 DEFINITIONS

3.1 Vitamin K deficiency bleeding (VKDB) of the newborn: previously referred to as hemorrhagic disease of the newborn. It is unexpected and potentially severe bleeding occurring within the first week of life. Late onset VKDB can also occur in infants 2-12 weeks of age with severe vitamin k deficiency. Bleeding in both types is primarily gastro-intestinal and intracranial.

3.2 Vitamin K1: also known as phytonadione, an important cofactor in the synthesis of blood coagulation factors II, VII, IX and X.

4.0 GUIDELINES

Infants greater than 1500 gm birthweight

4.1 Administer Vitamin K 1 mg IM as a single dose within 6 hours of birth. 4.1.1 The infant’s primary health care provider (PHCP): offer all parents the administration of vitamin K intramuscularly (IM) for their infant. 4.1.2 If parent(s) refuse any vitamin K administration to the infant, discuss the risks of no vitamin K administration, regardless of route, with the parent(s). (Refer to 3.1) 4.1.3 If parents refuse IM administration but accept oral, discuss these risks with parents (see 4.2). Proceed with oral dosing as outlined below if the parents continue to refuse IM. 4.1.4 Document the discussion and parent’s decision related complete refusal or alternate route of vitamin K administration in the infant’s medical record.

4.2 IM (intramuscular) administration is the preferred route in newborns as there are case reports indicating that IV (intravenous) administration may not prevent late onset Vitamin K deficiency bleeding. Oral administration results in both decreased efficacy and extended dosing in which subsequent doses may fail to be administered. There is a greater risk of Vitamin K deficiency bleeding in infants who have received oral Vitamin K.

4.3 Administer oral Vitamin K dosing according to the following schedule: 4.3.1 Initial dose: 2 mg with first feeding within 6 hours of birth  First repeat dose: 2 mg at 2 - 4 weeks postnatal age  Second repeat dose: 2 mg at 6 - 8 weeks postnatal age Title: Page: Vitamin K for the Prevention of Vitamin K Deficiency Bleeding (VKDB) in Newborns 2 of 3

4.3.2 Oral Vitamin K can be administered using the Vitamin K 2 mg/mL injectable product . Alternatively, the Vitamin K 10 mg/mL injectable product may be diluted in sterile water to a concentration of 1mg/mL and administered orally.

Infants less than or equal to 1500g, but greater than 1000g

4.4 Administer Vitamin K 0.5 mg IM as a single dose within 6 hours of birth.

4.5 IM administration is the preferred route in this patient population

Infants less than or equal to 1000g

4.6 Vitamin K 0.5 mg IV (over 15 minutes) within 6 hours of birth, followed by repeat dose at one month of age.

4.7 IV administration is the preferred route in this patient population due to lack of adequate muscle mass for IM administration at birth.

4.8 To prepare Vitamin K for IV administration, the formula below may be followed in order to provide enough solution to prime tubing for administration over 15 minutes: 4.8.1 Vitamin K 2 mg/mL amp 0.5 mL (1mg) D5W (diluent) 3.5 mL Final Volume 4 mL

*Final Concentration = 0.25 mg/mL *Dose 0.5 mg = 2 mL of prepared solution

4.9 Give a repeat dose at one month of age since IV Vitamin K may not prevent late onset Vitamin K deficiency bleeding. Administer the repeat dose by the IM route with the following dosage: 4.9.1  If greater than 1500g: 1 mg IM  If less than or equal to 1500g, but more than 1000g: 0.5 mg IM  If less than or equal to 1000g: 0.5 mg IV  If no IV line available: 2 mg PO

5.0 REFERENCES

5.1 WRHA. Vitamin K Monograph. WRHA Pediatric Parenteral Drug Manual; (2017) [cited 2017 Oct 13]. Available from: http://hschome.hsc.mb.ca/policies/

5.2 Sankar MJ, Chandrasekaran A, Kumar P, Thukral A, Agarwal R, Paul VK. (2016) Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. Journal of Perinatology; 36(Suppl1): S29-35.

5.3 Canadian Pediatric Society, Fetus and Newborn Committee (1997). Routine administration of vitamin K to newborns. Paediatric Child Health; 2(6):429-31. Reaffirmed February 1, 2016.

5.4 Takemoto CK, Hodding JH, Kraus, DM. (2015) Pediatric & Neonatal Dosage Handbook, 22nd ed. Hudson, Ohio, Lexi-Comp, Inc. ; 1698-1700.

5.5 Johnson, P.J. (2013) Vitamin K Prophylaxis in the Newborn: Indications and Controversies. Neonatal Network ; 32(3):193-199

5.6 Clarke P, Mitchell S. (2003) Vitamin K prophylaxis in preterm infants: current practices. Journal of Thromb Haemost; 1:384-386.

Title: Page: Vitamin K for the Prevention of Vitamin K Deficiency Bleeding (VKDB) in Newborns 3 of 3

5.7 American Academy of Pediatrics, Committee on Fetus and Newborn. (2003) Controversies concerning vitamin K and the newborn. Pediatrics;112(1): 191-192.

6.0 PRIMARY AUTHORS

6.1 Pat Wat, Pharmacist, Health Sciences Centre 6.2 Teresa Keith, Pharmacist, St. Boniface General Hospital 6.3 Doris Sawatzky-Dickson, Neonatal Clinical Nurse Specialist, Health Sciences Centre