Vitamin K for babies

Vitamin K and newborn babies

About VKDB
The history of vitamin K injections
The safety of vitamin K
The effectiveness of vitamin K for
babies
How is vitamin K given?
The FAQ's for parents considering declining vitamin K for their baby

What is vitamin K for?

Vitamin K is a fat-soluble vitamin that is needed for our bodies to form a
substance called 'prothrombin'. Prothrombin is one (of many) essential blood
components required to create our normal blood clotting mechanism, used to
prevent and control excessive bleeding. If the Vitamin K levels in our body are low,
the person is said to have a 'Vitamin K Deficiency', giving them a tendency to
bleed.
Our bodies obtain vitamin K in two ways:
A small amount comes from the foods that we eat, such as green, leafy
vegetables and other green vegetables, cauliflower, vegetable oils,
diary products, Soya beans and eggs. This is known as vitamin K1 (or
'phylloquinone').
However, most of our vitamin K is obtained through the synthesis of
normal bacteria present inside our bowel, and then stored in our liver.
This is called vitamin K2 (or 'menaquinone') and is produced in more
than adequate amounts to protect us from bleeding, even if our diet is
inadequate.

Vitamin K and newborn babies

All newborn babies have a natural degree of vitamin K deficiency at birth, usually
about 40 to 70% less than adult levels. These levels are adequate to protect
babies from bleeding, but can be quickly depleted if the baby is unable to replace
and build up their vitamin K stores in the weeks and months following the birth (to
keep up with what their body is using). In rare cases the levels can lower even
further than those at birth, creating an unsafe deficiency.
During the pregnancy vitamin K1, (obtained through food eaten by the mother),
does not cross the placenta to the baby in large quantities (only about 3 to 4 %).
The Vitamin K2 that is produced by the mother's bowel bacteria is unable to be
transmitted to the baby.
Once babies are born, they start to obtain a little Vitamin K1 through feeding.
Breast milk contains very small amounts of vitamin K1, (about 1 to 2 micrograms
per litre). Infant formula milks are regulated by law to contain a minimum of 30
micrograms per litre. This means that babies who are exclusively breastfed are at
an increased risk of having a vitamin K deficiency in the early months.
Most of the Vitamin K needed by the baby is obtained through a slow build up of
their gut bacteria in the weeks, or months, after the birth, producing their vitamin
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K2. A baby's bowel is 'sterile' when inside the uterus (meaning no bacteria) and
does not start producing vitamin K2 until after they are born. Once in the 'outside
world' the baby's bowel starts colonising the normal 'body-friendly' bacteria. This
is done by sucking on their hands, latching on the breast etc. starting the
production of vitamin K2. The vast majority of babies will increase their vitamin K
to adult levels by the time they are 6 weeks old.
While most newborn babies are able to create adequate Vitamin K2 to maintain
and increase their levels, occasionally a baby does not achieve this and may
experience Vitamin K deficiency. In rare cases a baby can take up to 6 months to
reach adequate levels of vitamin K2, and therefore be prone to bleeding up until
this time.
This condition for babies is called 'Vitamin K Deficiency Bleeding' or 'VKDB'
(previously known as Haemorrhagic Disease of the Newborn or 'HDN'). It is
diagnosed after the baby shows signs of bleeding with a blood test. Their blood
test shows longer 'clotting times', despite still having other normal levels of blood
clotting factors such as fibrinogen and platelets. The condition is confirmed once
the baby's blood clotting returns to normal soon after vitamin K has been given.
As a way of preventing VKDB in a few babies, all parents in Australia are
encouraged to give their newborn baby some form of supplement of Vitamin K
soon after the birth, just in case. Vitamin K supplements are aimed at preventing
a further drop in the baby's vitamin K levels, while they are building up their gut
bacteria in the early weeks or months after being born.
Vitamin K supplements are administered by your caregiver, either by one injection
within hours of the baby's birth or as 3 oral doses (by mouth) in the first month of
the baby's life. (This is the standard in Australia; other countries may have
alternative recommendations.)
Vitamin K supplements are administered by your caregiver, either by one injection
within hours of the baby's birth or as 3 oral doses (by mouth) in the first month of
the baby's life. (This is the standard in Australia; other countries may have
alternative recommendations.)

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The history of vitamin K injections

Injections of vitamin K for babies were first
introduced in Australia in the early 1970's.
They were originally only given to sick,
premature infants, but by 1980 were given
routinely to all babies (sometimes without the
formal consent by the parents, it was just
done!). The dose was usually 1 mg, or 0.5mg
for very small premature babies.
The original vitamin K injections (known as
'Konakion') were developed in the 1950's. They contained phytomenadoine
(Vitamin K1) as well as glycol, phenol and polyethylated castor oil. The latter
substances mixed in with the Vitamin K1 were known to possibly cause local
irritation in the baby's skin when given as an injection and irritation of the baby's
stomach and bowel when given orally.
In the last 10 years or so some parents started expressing a desire to avoid giving
their baby an injection soon after the birth. In response to this caregivers used the
original Konakion injection medication and administered it orally to the baby, due
to the absence of having a specially prepared oral substitute available. A few
major hospitals did develop their own oral Vitamin K powder (that could be mixed
with water or breast milk), as an alternative to using the injectable medication. At
first, only one dose was given, usually on the day the baby was born. This was
soon changed to 3 doses in the baby's first month of life, to improve the
protection for Late VKDB.
In October 2000, the original Vitamin K injection (or Konakion) was discontinued. It
has now been replaced by a new formulation called 'Konakion MM Paediatric' (still
usually referred to as just 'Vitamin K' by most caregivers). This contains the
Vitamin K1 (called 'phytomenadoine') and naturally occurring substances called
sodium glycocholate (bile acid) and lecithin, making it much more suitable for oral
administration, as well as an injection.
At present about 95% of all newborn infants receive an injection of Konakion MM
Paediatric soon after birth, with most remaining babies receiving 3 oral doses
during the baby's first month of life (usually at the parent's request). A few
parents will choose to decline any Vitamin K for their baby.
The safety of vitamin K
In Australia, Vitamin K injections have been given to most newborn babies since
about 1980. In 1992 a well-designed study from the UK (by Golding et al)
indicated that Vitamin K injections (not oral doses) could contribute to an
increased incidence of childhood leukaemia. When this was published, the
community made a shift towards choosing oral Vitamin K and caregivers began
introducing information sheets (and in some cases consent forms), before asking
parents to accept Vitamin K for their babies. In the years that followed, seven
subsequent studies failed to find any solid connections with childhood cancer,
unable to replicate the findings. When this was realised there was a shift back
towards injectable Vitamin K in Australia.
The National Health and Medical Research Council (NHMRC) in Australia has
released a statement in the year 2000, saying that Vitamin K injections ARE NOT
believed to be linked with childhood cancer, and have recommended that babies
continue to be given Vitamin K to prevent VKDB.

The effectiveness of vitamin K for babies

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The effectiveness of the 'old Konakion'

There have been no large studies conducted that definitely demonstrate how
effective the original Vitamin K (or 'Konakion') was in preventing VKDB. We simply
have extensive records documenting cases of VKDB and if the affected baby had
Vitamin K as an injection, or oral dose(s), or no Vitamin K at all.
The effectiveness of Vitamin K given to newborn babies is believed to depend on
the type of VKDB and the way the Vitamin K was administered.
Early VKDB. It is believed that the incidence of Early VKDB (occurring on day 1) is
greatly reduced if mothers taking certain medications (usually for epilepsy,
tuberculosis or heart disease) receive tablets of Vitamin K, (generally about 20 mg
daily), every day for the last 2 to 4 weeks of their pregnancy. Babies born to these
mothers can also benefit from receiving an injection of Vitamin K within the first
hour of being born, as they may not be able to absorb oral Vitamin K.
Classical VKDB. It is believed that Classical VKDB (occurring from day 2 to 7) can
be virtually eliminated if the baby receives either an injection of Vitamin K OR an
oral dose of Vitamin K within 24 hours of being born.
Late VKDB. It is believed that the incidence of Late VKDB (occurring from day 8 to
6 months, commonly occurring around 4 to 12 weeks), can be reduced from
0.44% - 1.5% down to less than 0.0003% with one injection of Vitamin K (usually
given on the baby's day of birth).
The alternative of giving babies 3 oral doses, (usually on Day 1, then Day 4 to 7,
and then at 1 month after the birth), will decrease the incidence of late VKDB to
about 0.0015 to 0.0018%. This is if all 3 doses are given. In practice, the reality is
that some parents overlook giving all 3 doses, and the true incidence is about
0.0025% to 0.0026%.
In countries such as the Netherlands and Denmark, babies are given Vitamin K
orally every week for 12 weeks. This has shown to be just as effective as the
single injection, but in reality can be difficult for parents to comply with and is also
expensive.
A single oral dose (which used to be recommended when oral Vitamin K was first
introduced) is less effective with Late VKDB occurring at a rate of about 0.0015%
to 0.0065%.

The effectiveness of the new 'Konakion MM Paediatric'

At present there is no definite data available to demonstrate the effectiveness of
the new 'Konakion MM Paediatric' for preventing VKDB. Given as an injection, it is
believed to be similar to the previously available 'Konakion'. There is a small
concern about how long the new injection lasts and if it is sufficient to protect the
baby from late VKDB. It has been shown that 70% of babies will have adequate
Vitamin K levels at 56 days of age after receiving Konakion MM Paediatric as an
injection.
Some caregivers suggest a further oral dose of the Konakion MM Paediatric when
the baby is due for immunisation at 8 weeks of age. This has not become a
general recommendation because the majority of babies who present with Late
VKDB after 8 weeks will usually have been born with an underlying liver disorder,
meaning that the extra dose of Vitamin K will not be beneficial to them. (It is very
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rare for a baby without a liver disorder to show signs of late VKDB after this time).
Konakion MM Paediatric is absorbed very well when given orally. When 3 doses are
given as scheduled in the first month, it has shown that 89% of babies will have
adequate Vitamin K levels at 56 days of age.
In Switzerland 95% of babies have received two oral doses (2mg) since 1995
(usually on days 1 and 4 after the birth). In a 3 year study looking at 247,000
babies, there was 1 case of classical VKDB (0.0004%) and 11 cases of late VKDB
(9 of these 11 babies had liver disease). Of the other 2 babies, 1 baby had no
Vitamin K and the other had the normal 2 doses (again an incidence of 0.0004%).

How is vitamin K given?

In Australia, vitamin K is offered by caregivers as either:
A single injection on the day of the baby's birth (1mg - 0.1mls, or 0.5mg - 0.05mls
for very small premature babies),
OR
3 Oral doses (2mg per dose, or 0.2mls per dose). These should be given on:
1. The 1st dose on the day of the baby's birth.
2. The 2nd dose around about days 4 to 7 after the birth, usually when the baby
receives their Newborn Screening Test.
3. The 3rd dose when the baby is 1 month old. This may need to be done by your
local doctor or early childhood health worker.

NOTE: If your baby vomits within 1 hour of having their oral Vitamin K the dose
will need to be repeated.
The Vitamin K should be recorded on your baby's personal health record book.
The advantage of an injection is that it is a one off dose and there is no need to
remember to give further doses. The disadvantage of an injection is that it can be
briefly painful for the baby, and holds small risks of bruising and infection at the
skin site of the injection (less than 1%).
The advantage of the oral doses is that it is not painful for the baby and does not
carry the small risks of the injection. The disadvantage of the oral doses is that
parents need to remember to give their baby all the doses. Usually the last one at
1 month is the most frequently missed, as the caregiver will normally ensure the
first 2 doses are given.

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Considerations when declining vitamin K

Parents who conscientiously object to their newborn baby receiving some form of
Vitamin K supplement soon after the birth may find they encounter negative
comments, criticism and often pressure to give their baby Vitamin K by some
caregivers. If you have made this decision, then you should prepare yourself for
these types of responses.
You may wish to be flexible in your decision if your baby is unwell or not feeding
frequently. If you do notice signs of VKDB in the first 6 months of your baby's life,
it is important that you seek medical attention immediately and that the baby is
given an injection of Vitamin K as soon as possible.

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