Vitamin K prophylaxis and Vitamin K Deficiency Bleeding

 

Reviewed by Clinical Practice Committee
August 2013
Clinical Guidelines Back Newborn Services Home Page
Recommendations Dosage Informed Consent Vitamin K Deficiency
Vitamin K Deficiency Bleeding Risk of Vitamin K Deficiency Bleeding and Oral vs IM Vitamin K Potential Risks of Vitamin K Side Effects of Vitamin K
Obtaining Konakion MM Paediatric References
 

Introduction

Purpose: This document has been formulated to provide recommendations for staff working at National Women's Hospital with regard to Vitamin K prophylaxis and vitamin K deficiency bleeding.

Scope:  This document applies to all medical, nursing and midwifery staff working within National Women's maternity and newborn services.

Associated documents:  The table below indicates other documents associated with this policy.

 

Type

Document Title(s)

Board Policy
  • Informed Consent
Hospital Policy
  • N/A
Other
  • Consensus Statement ‘Vitamin K prophylaxis in the Newborn’. Fetus and Newborn Committee of the Paediatric Society of NZ, The NZ College of Midwives (Inc.), The NZ Nurses Organisation, The Royal NZ College of General Practitioners, The Royal NZ College of Obstetricians and Gynaecologists. August 2000
Supporting Literature
  • Refer to references at the conclusion of this document.

Recommendations

The August 2000 consensus statement of Fetus and Newborn Committee of the Paediatric Society of NZ, The NZ College of Midwives (Inc.), The NZ Nurses Organisation, The Royal NZ College of General Practitioners, The Royal NZ College of Obstetricians and Gynaecologists recommends that all babies receive vitamin K prophylaxis.

Dosages for IM and Oral Vitamin K

IM Administration

The recommended route of administration is intramuscular, being given at birth, and that this should be as a single IM injection:

Parents should be advised that with intramuscular injection, the risk of Vitamin K deficiency bleeding is extremely low.

Oral Administration

If parents do not consent to IM but consent to oral vitamin K, this needs to be given in 3 separate doses according to the following regime:

Parents should be advised that even with full compliance with this regime, cases of Vitamin K deficiency bleeding (VKDB) although rare still do occur. Surveillance and reporting of any bleeding is therefore important. The at risk time is up until the infant is receiving something other than breast-milk in their diet.

If the infant vomits or regurgitates within 1 hour of an oral dose, this dose should be repeated.

One difficulty with oral vitamin K is ensuring that repeat doses are administered. They are often omitted. This is the responsibility of the LMC and the parents. Repeated doses lowers further the risk of late VKDB

Informed Consent

The administration of vitamin K should have been discussed with the parents by the LMC prior to labour or delivery. If paediatric staff are at the delivery the LMC should inform them of the parents’ decision.

Verbal consent is necessary for vitamin K administration and is to be documented in the Mother’s clinical record at the time of antenatal discussion and on the delivery summary. Parents should be provided with the hospital information booklet on vitamin K.

Background

Vitamin K Deficiency

Vitamin K Deficiency Bleeding

Early:
  • Occurs in babies of mothers on anticonvulsants, especially phenobarbitone and phenytoin or maternal coumarin products.
  • It can also occur if mother is on anti-tuberculous therapy (rifampicin and isoniazid). Two series reported bleeding (some very serious) in the babies of 14 of 21 mothers and 8 of 111 mothers. Women in this situation should be treated with oral vitamin K 20mg/day for 2 weeks prior to delivery.1
Classical:
  • Usually bleeding between day 2 and 5.
  • Incidence of 0.4 to 0.7/100 births with no vitamin K prophylaxis.
  • Bleeding sites include intracranial, gastrointestinal and umbilical haemorrhage.
Late:
  • 2-12 weeks of age.
  • Usually occurs in breast fed babies who have not received vitamin K.
  • Bleeding can be severe, with half being intracranial.
  • This is often associated with cholestatic liver disease, however this liver disease may be asymptomatic and bleeding is the first clinical manifestation.

Risk of Vitamin K deficiency bleeding and Oral vs IM Vitamin K

The Risk of Vitamin K deficiency bleeding (VKDB)

Oral vs IM Vitamin K

  Australia15 Europe
Expressed as rate per 100,000 babies
No Vitamin K 34.4  
1 dose of oral Konakion(R) 20  
2 doses of 2mg oral Konakion MM(R)   5
3 doses of oral Konakion(R) 4.1 2.6
3 doses of 2mg oral Konakion MM(R)   0.44
1 dose of IM Konakion(R) 0.2 0.0

New Zealand Data16

The New Zealand Paediatric Surveillance Unit (NZPSU) process involved cards (now emails) sent monthly to all registered paediatricians, paediatric surgeons and other clinicians working predominantly with children. They are asked to indicate by return whether or not they have seen any of the listed condition in the last month. Vitamin K deficiency bleeding (VKDB) was included on the NZPSU card from January 1998 until December 2008.

Over the 11 years the response rate to the cards, including notification that none of the listed conditions had been seen was 94.5%. There were 23 valid cases identified, 3 were classified as early, 10 were classified as classic and 10 as late disease. The male to female ratio was 2:1.VKDB was largely confined to fully breastfed infants who did not receive vitamin K at birth.

Potential Risks of Vitamin K

There are now 10 studies investigating whether there is an association between vitamin K and childhood cancer. There is no proven risk of cancer or leukaemia. A risk of solid tumours can almost definitely be ruled out but a small risk of leukaemia cannot be excluded. 1-10

Six studies showed no link with cancer. In the studies that show an increased risk of cancer or leukaemia, the vitamin K policies were to administer IM vitamin K or any vitamin K to selected babies only. Some of the findings may be explained by there being other risk factors associated with these selected babies. 6, 7, 13

There is no established risk of childhood cancer with IM vitamin K. Any small and unproven risk has to be balanced against the known risk of developing classic and late VKDB with potentially fatal or debilitating outcomes if either no vitamin K is administered or even if the oral route is chosen. An additional advantage of the IM route is now a long established time of usage with this with no proven safety issues. The oral empirical route had not been in place for many years and there is still a chance of some as yet unknown risk that may become apparent with time. This must be balanced against the proven risk of serious bleeding in a small but not easily identifiable group of babies with either no vitamin K or the oral regimes.

Supporting Literature

Side Effects of Vitamin K

These are largely confined to local effects and the side effects of an IM injection. Exacerbation of jaundice and haemolysis does not occur with the doses now used or the naturally occurring lipid soluble vitamin K1 (Konakion(R)). These were problems years ago with water-soluble vitamin K given in very large doses. IV administration can produce local reactions. The MM preparation is relatively new.

Risks associated with the injection technique include infection, irritation of the injection site or nerve and muscle damage as the Vitamin K injection must be given deeply into the muscle. These are very rare complications.

Obtaining Konakion MM Paediatric

General Information

Dispensing & Administration of 2nd and 3rd doses

Obtaining Konakion Out of Pharmacy Hours

References

1 von Kries R. Neonatal vitamin K prophylaxis: the Gordian knot still awaits untying. BMJ 1998; 316: 161-2
2 Golding J. Factors associated with childhood cancer in a national cohort study. Br J Cancer 1990; 62: 304-8.
3 Golding J. Childhood cancer, intramuscular vitamin K, and pethidine given during labour. BMJ 1992; 305: 341-46.
4 Klebanoff MA, The risk of childhood cancer after neonatal exposure to vitamin K. N Engl J Med 1993; 329: 905-8
5 Ekelund H, Administration of vitamin K to newborn infants and childhood cancer. BMJ 1993; 307: 89-91
6 Ansell P, Childhood leukaemia and intramuscular vitamin K: findings from a case-control study. BMJ 1996; 313: 204-5
7 von Kries R, Vitamin K and childhood cancer: a population based case-control study in Lower Saxony, Germany. BMJ 1996; 313: 199-203.
8 McKinney PA. Case-control study of childhood leukaemia and cancer in Scotland: findings for neonatal intramuscular vitamin K. BMJ 1998; 173-7.
9 Passmore SJ. Case Controlled studies of relationship between childhood cancer and neonatal vitamin K administration. BMJ. 1998; 316: 178-84.
10 Passmore SJ. Ecological studies of relation between hospital policies on neonatal vitamin K administration and subsequent occurrence of childhood cancer. Br Med J 1998; 316: 184-9
11 Parker L. Neonatal vitamin K administration and childhood cancer in the north of England: retrospective case-control study. Br Med J 1998; 316: 189-93
12 Cornellison M., et al. Prevention of Vitamin K deficiency bleeding: efficacy of different multiple oral dose schedules of Vitamin K. European J of Paed 1997; 156: 126-130.
13 Zipursky A. Prevention of Vitamin K deficiency in a newborn. Brit J Haematology 1999; 104: 430-437.
14 von Kries A.. Oral mixed mycellular Vitamin K for the prevention of late Vitamin K deficiency bleeding. Arch Dis Child Fetal Neonatal Ed. 2003; 88: F109-112.
15 Loughnan P, et al.  The frequency of late onset haemorrhagic disease (HD) in Australia with different methods of prophylaxis, 1993-1997.  An update.  J Paediatr Child Health 1999;38:A8.
16 Darlow B, et al. New Zealand surveillance of neonatal vitamin K deficiency bleeding (VKDB): 1998-2008. J Paed Child Health 2011; 47:460-464