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Vitamin K deficiency bleeding and prophylaxis in the newborn

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This guideline 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.

Vitamin K Deficiency

Newborn babies have low levels of vitamin K. They have low plasma concentrations and low levels of vitamin K dependent clotting factors. This deficiency intensifies in the days after birth. Newborn levels are considerably lower than maternal levels.

Severe vitamin K deficiency can develop quickly in breast fed infants and can result in the appearance of classic vitamin K deficiency bleeding (VKDB) during the first week of life or late VKDB during the first two months of life. Both forms of the disease can be severe, causing brain damage and death.  This situation is very unlikely to occur in formula fed infants as the levels of vitamin K are higher in formula milk.

Vitamin K Deficiency Bleeding (VKDB)

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. 

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.

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.

  • Any change in consent to the route of administration should be clearly documented on the Blue card or in the clinical record.
  • If vitamin K is not given to these or any infants under paediatric supervision, this should be discussed with the paediatric specialist on service.

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:

  • Term babies 1mg IM soon after birth
  • Preterm babies <1500g, 0.5mg IM soon after birth

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 regimen:

  • 2mg oral soon after birth
  • 2mg oral at 3-7 days
  • 2mg oral at 6 weeks

Parents should be advised that even with full compliance with this regimen, 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

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

The known risk factors for vitamin K deficiency bleeding VKDB are:

  • Maternal anticonvulsant, especially phenobarbitone and phenytoin
  • Surgery
  • Breastfed infants

Some authors have recommended policies of selective vitamin K administration to 'high risk' infants. There is no basis for their definition of 'high risk' (Babies with traumatic delivery, low birthweight and sick babies).

Late VKDB occurs almost exclusively in breast fed infants.13

Oral vs IM Vitamin K

Oral vitamin K does not fully protect against late VKDB. Data is available from Australia and Europe. The topic has recently been extensively reviewed and the data and recommendations of this policy reflect upon these studies.12, 13

   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 Data

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 excluded1-10.

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 babies6, 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 regimens.

Supporting Literature

  • Golding's original study showed an association between childhood cancer and maternal smoking and drug administration to the baby (vitamin K was the commonest drug; there was no information whether this was oral or IM).2
  • A case-control study by the same authors showed an increase risk of childhood cancer after IM vitamin K administration, but not oral vitamin K. The confidence intervals of IM vs oral vitamin K overlapped.3
  • A study of 54,000 deliveries in USA found no link with childhood cancer.4
  • A study of 1,384,000 babies in Sweden showed no link between IM vitamin K and childhood cancer.5
  • Two case controlled studies of 132 and 272 children with cancer did not support an increased risk of cancer in babies given IM vitamin K.6,7
  • A population based case-control study of 515 children in Scotland did not support a relationship between IM vitamin K and childhood cancer.8
  • Borderline significant association between IM vitamin K and childhood cancer found in a case controlled study in England. Possibly explained by an effect of abnormal delivery.9
  • An ecological study by the same authors found there was unlikely to be an increased risk of childhood cancer attributable to vitamin K given to newborns.10
  • Another case control-study of 685 children with cancer showed no relationship between IM vitamin K and all cancer or leukaemia, but there was an association with leukaemia developing in the 1st 6 years. These cases/controls were born in hospitals that gave vitamin K only to 'at risk' babies. However, no association was found in babies from hospitals that give all babies vitamin K.11

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®). 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

  • Konakion MM Paediatric 2mg in 0.2ml ORAL or injection is held in the Pharmacy Imprest Cupboard on Wards 96, 98, Tamaki, Delivery Unit, Theatre and NICU.
  • When this preparation is prescribed orally the second and third doses may need to be administered after the baby has been discharged from hospital.
  • This is to be documented on the discharge summary, Tamariki Ora booklet and on referral to the Well Child provider.
  • If National Women's is the LMC or providing postnatal care, the second and third doses required after patient discharge must be administered or supervised by the midwife carrying out the postnatal homecare visits.
  • Administration of all doses is to be documented in the baby's clinical record.
  • The person doing the six week check is to be informed if the baby needs oral vitamin K.
  • The GP should also be made aware of:
    - baby who has not had any vitamin K
    - whether baby had oral or IM dose.

Dispensing & Administration of 2nd and 3rd doses

For babies under the care of ADHB Domino Midwives, or Home Care Midwives the second and third doses can be administered from ADHB stock as follows:

  • Vit K (PO) is prescribed on an ADHB Drug Chart with a patient label attached.
  • Fax the chart to Pharmacy (fax 22301).
  • Indicate on the chart if the Midwife is to collect the medication from Pharmacy, alternatively the medication can be sent to a ward. (Drugs can not be issued directly to patients.)
  • Pharmacy will dispense the medication with the understanding that the administration is undertaken or supervised by the Domino Midwife or Homecare.

Obtaining Konakion Out of Pharmacy Hours

If oral Konakion is required outside pharmacy hours it will be necessary to contact the On Call Pharmacist through the Duty Manager.

Information for families

Newborn Services information leaflet on Vitamin K for families

Associated documents

  1. Board Policy - Informed Consent
  2. 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
  3. Patient Information: Vitamin K for the Prevention of Haemorrhagic disease of the Newborn - Information for parents.
  4. Guide statement and recommendations on Vitamin K administration to newborn infants to prevent Vitamin K deficiency bleeding in infancy: The Royal Australasian College of Physicians 2001.

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

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Document Control

  • Date last published: 08 October 2018
  • Document type: Clinical Guideline
  • Services responsible: Neonatology
  • Owner: Newborn Services Clinical Practice Committee
  • Editor: Sarah Bellhouse
  • Review frequency: 2 years