Vitamin K prophylaxis for neonates

Formulary Link

The administration of an Intramuscular dose of Vitamin K (phytomenadione) is recommended for all babies born in the West of Scotland. It should be administered soon after birth. This is a ONCE ONLY dose. The dose is:-

- 1mg phytomenadione (0.1ml) IM for term infants (36 weeks gestation or greater).

A lower dose is recommended for infants < 36 weeks gestation. Two dosage regimes are in use in neonatal units in the West of Scotland.  The former is the recommended dose in GG&C

- 0.5mg phytomenadione (0.05ml) IM for all preterm infants less than 36weeks.

OR

- 400 micrograms/kg  (0.04 ml/kg) IM.

NB - A 1ml syringe must be used due to the very small volume for injection

If intramuscular injections are contraindicated (e.g. babies with inherited disorders of coagulation or babies with very low muscle mass) then vitamin K may be prescribed via the oral route or by intravenous injection if the enteral route is contraindicated or unreliable. See below.

Note - The oral route is not appropriate for high risk, sick, or premature infants. In addition, the manufacturers do not recommend this route for babies born to mothers who are taking carbamazepine, phenobarbital, phenytoin, rifampicin or warfarin at the time of delivery. If a mother of a baby in any of these categories declines parenteral vitamin K or if a mother declines vitamin K by any route - see later section – ‘Parents who decline vitamin K prophylaxis’.

Mothers of healthy, mature, infants who decline intramuscular vitamin K should be offered one of the following oral Vitamin K regimen.

Phytomenadione Paediatric - 2mg (0.2ml) orally, Three doses at 1, 7 and 28 days – Formulary Link

Administration - Phytomenadione Paediatric is supplied in glass ampoules. The first dose will be administered by midwifery staff. A prescription should be sent to pharmacy for the day 7 and 28 doses, these doses can be given by the community midwife/health visitor or parent /carer as appropriate.

Patient Information Leaflet

Formulary Link

Phytomenadione may be administered intravenously but this is not recommended for routine treatment. Intravenous administration is not covered by the PGD and must be prescribed by a doctor.

Phytomenadione must only be diluted with 5% glucose & not mixed with other intravenous medications or infusions. The line should be flushed with IV glucose 5% before and after administration.

As intravenous administration does not provide a depot of vitamin K the manufacturers recommend administration of additional doses at 7 days and 4 weeks of age.

Midwives Exemptions allow midwives to administer vitamin K without it having to be prescribed. The administration of phytomenadione (oral or IM) by nurses is covered by Patient Group Directions (PGDs). Administration under midwives exemption or PGD must be recorded according to local practice e.g. on Badgernet.

Parents are asked to provide verbal consent for the administration of intramuscular vitamin K. Staff should be aware of the following key points when discussing vitamin K administration, to ensure that this consent is fully informed.

• Vitamin K is required for the production of essential clotting factors in the liver. Haemorrhagic disease of the newborn (HDN) is caused by a deficiency of vitamin K. HDN may cause severe bleeding which may be fatal or cause severe brain damage. Bleeding can occur without warning.
• Vitamin K 1mg (or a lower dose for premature babies) intramuscularly gives universal protection against HDN ¹.
• Whilst some studies in the early 1990's suggested a link between IM vitamin K and childhood cancers, subsequent research has not confirmed these findings. Such a link is therefore deemed to be unproven and unlikely ². Therefore, the possibility of a link between IM vitamin K and childhood cancer should not be raised with parents when seeking consent for the administration of Vitamin K.
• It is the agreed policy therefore to give vitamin K intramuscularly. However, if some parents object to IM administration of vitamin K then the alternative offered is oral Vitamin K (see dosage & administration information above). This however does NOT guarantee full protection, particularly if some doses are vomited or missed. Babies with liver disease are at particular risk.

Listed below are some important factors.

• Breast milk contains LESS Vitamin K than formula milks and breast fed babies have a reduced intake in the first few days. As a result of this haemorrhagic disease of the newborn has the greatest incidence amongst breast fed babies. This is not a reason not to breast feed but a reason for Vitamin K prophylaxis.
• Vitamin K is a fat soluble Vitamin and is poorly absorbed from the gut when there is liver disease. Many liver diseases are not apparent for days or weeks after birth, therefore, these babies cannot be identified when prophylaxis is first given. Small, repeated doses of oral Vitamin K will reduce the risk. Midwives should be alert to the possibility of liver disease signified by prolonged jaundice after 14 days.
• Babies of mothers who are taking some enzyme-inducing drugs - carbamazepine, phenobarbital, phenytoin or rifampicin, or who are taking warfarin must have prophylactic Vitamin K given parenterally. These drugs antagonise Vitamin K in the baby.
• Some parents may ask about the halal or vegan status of this medicine. There is only the one product available, which does contain an animal derived ingredient. There is no alternative medication available for this indication and some may consider that given the potentially life saving nature of this medicine, administration would be allowed.

Parents of healthy term babies have the right to refuse consent for vitamin K prophylaxis by any or all routes. However, we have a duty to explore the reasons for complete refusal and ensure that they are correctly informed of the risks of Vitamin K deficient bleeding and the potential for serious long term morbidity or mortality. If, having explored the reasons for refusal and having ensured that they are correctly informed of the risks, they continue to refuse prophylactic vitamin K then this conversation and their decision should be clearly documented in the baby notes. It is not appropriate to get the parents to sign a medical ‘disclaimer’. This discussion should be with a Middle Grade or Consultant Paediatrician.

Where a baby is clearly at high risk of bleeding however, vitamin K is required as treatment rather than prophylaxis and should always be administered in the best interests of the baby.

Such cases would include:

• Prematurity
• Sepsis
• Liver disease
• Maternal treatment with enzyme inducing drugs including e.g. Anticonvulsants and Rifampicin
• Prolonged Prothrombin time

Information to be given to parents if vitamin K prophylaxis is declined

• Vitamin K is an essential vitamin required by the liver to make ‘clotting factors’. Clotting factors are natural chemicals produced by the liver which circulate in the blood and respond to bleeding by helping blood clots to form.
• Babies who do not get enough vitamin K are at risk of bleeding excessively over the first few days and weeks of life. This is called vitamin K deficient bleeding (VKDB) or Haemorrhagic Disease of the Newborn (HDN).
• Bleeding most commonly occurs between day 2 and day 7 of life. This is known as ‘Classical’ VKDB. Bleeding may also occur later than this over the following few months. This is known as ‘Late’ VKBD. Both Classical and Late VKDB are preventable by giving the baby vitamin K.
• Rarely, bleeding can occur on day 1 of life. This is called ‘Early’ VKDB.
• The excessive bleeding seen in VKDB may appear as severe or unexplained bruising, oozing of blood from the umbilical stump or from injection sites, nose bleeds or bleeding from the stomach or bowel. These types of bleeding serve as a warning that the baby’s blood is not clotting but seldom cause severe illness.
• The main concern however, is bleeding within the brain which can occur without any warning and may lead to permanent brain damage or death.
• Breast milk, whilst being the healthiest way to feed your baby, contains very little vitamin K and the majority of bleeds reported in the UK occur in babies who have been fed exclusively with breast milk ³. Most of the other bleeds were seen in babies fed with soya based formula milk or who are absorbing vitamin K poorly due to liver disease ³ .
• Severe bleeding can be almost completely prevented by giving Vitamin K at the time of birth by an intramuscular injection. And this is the reason that West of Scotland maternity units recommend this treatment for all babies. This recommendation is supported by all major health agencies⁸
• Vitamin K given by mouth, according to the schedules above, is almost as effective as the intramuscular injection. However a number of babies each year are reported to have had bleeds because some doses were missed or because the baby vomited shortly after the dose was given or because the Vitamin K did not get absorbed due to liver disease in the baby. Because of this we recommend intramuscular vitamin K as the safest option. However, if parents do not want the intramuscular injection then oral treatment can be offered.
• If no Vitamin K is given at birth the risk of spontaneous bleeding for all babies is around 1:8500 ⁴. The risk for exclusively breastfed babies is higher - around 1:1200 ⁶. Many more of these babies - up to 1:80, may show excess bleeding following minor surgical procedures such as circumcision ⁷.
• Babies with specific risk factors including liver disease, prematurity or those born to mothers who are on medicines for epilepsy are at a much higher risk and treatment of these babies with Vitamin K is essential.

Resources for Families

Families can be directed to the leaflet attached to the end of this document

Vitamin K for newborn babies: Information for parents (pdf)