What is the issue with vitamin K and informed consent?
Parenting choices
Whether to give vitamin K to their baby is often the first decision parents will need to make following the birth and this usually happens within the first hour. It is generally assumed that parents will agree to giving it, and that discussion only needs to take place about how the baby will receive the vitamin K. The choices for this are, orally where drops are given into the baby’s mouth or intramuscular injection. From talking to parents my understanding is that the topic is rarely discussed fully and that their knowledge of the issues even after the discussion is quite limited.
Informed Consent
How is it that we, as health professionals, understand the legal principle that those people with parental rights need to provide informed consent for interventions involving their children, but then in certain circumstances overlook that right? The belief that healthcare professionals know best, and can tell people which choices to make, is outdated and not supported in law.
So, why is there little discussion about vitamin K? It is certainly not a straightforward issue, but that is no reason not to talk about it and to ensure parents understand the issues so that they can make informed decisions. Whilst healthcare professionals and policy makers develop standardised care pathways that address issues on a population basis, resulting in the recommendation to give vitamin K to all babies, parents still have the right to make individualised choices for their babies.
Prophylaxis
The vitamin K given routinely after birth is a form of prophylaxis. This means it is given as a preventative measure rather than as a treatment for a condition the baby has developed. It is offered because all babies are born with lower levels of vitamin K, compared to older children and adults, and it is one important component in a complex system that prevents bleeding.
Why do all babies have lower levels of vitamin K? The answer is we don’t know, but the medical assumption is that the relative low level means there is a deficiency which needs correcting. Vitamin K is offered to all newborn babies with the aim of preventing a bleeding disorder from developing in a small number of babies who cannot be identified before the condition becomes apparent. So, thousands of babies need to be treated in order to protect one baby who would otherwise become affected.
Vitamin K deficiency bleeding
The bleeding disorder is called vitamin K deficiency bleeding (VKDB) and happens in three different timeframes:
Early-onset – the disorder develops within the first 24 hours of life and is almost entirely associated with specific drugs prescribed to mothers, including anticoagulants, anticonvulsants and certain antibiotics. This form of the disorder is not prevented by giving vitamin K prophylactically.
Classic-onset – the disorder develops between 2 and 7 days after birth. Bleeding can occur in the gut, the nose or from any wounds. Prophylaxis does very significantly reduce the incidence of VKDB but may not eradicate it entirely.
Late-onset – the disorder develops between 8 days and 4 months of age. It can happen if the baby is not able to build up reserves of vitamin K through feeding, production in the gut or storage in the liver. Late-onset VKDB presents the most serious danger and is the form that risk analysis focuses on. Bleeding can occur in the brain, gut or skin, and can result in severe illness and, in very rare cases, death. Prophylaxis does significantly reduce the incidence of late-onset VKDB, however, late bleeding is often found to be secondary to liver disease and in these cases it may not prevented by prophylaxis.
Incidence of late-onset VKDB
The incidence of late-onset VKDB in untreated babies is approximately 1:11,000, although some resources (US Centers for Disease Control and Prevention) quote a much rarer incidence of 1:25,000. Most babies who develop late-onset VKDB will recover fully with prompt treatment. A small study (McNinch et al. 2007) has shown that 1% of those babies who developed late-onset VKDB died, so whilst the chance is small, the consequences can be serious.
The group of babies most affected these days are those who are breastfed, and not given prophylactic vitamin K. Because formula milk is supplemented with very high levels of vitamin K babies fed this way have reduced incidence of VKDB. Although you may hear that breastmilk is deficient in vitamin K this is not true, breastmilk contains physiological levels of vitamin K and babies with a healthy gut microbiome, helped by breastfeeding, will start to produce their own vitamin K a few days after birth. Whilst this process has evolved and works for the vast majority of babies, there is, for a very small number of babies (1:11,000), an issue, often unidentified, that leads to the bleeding disorder.
Risk factors for late-onset VKDB
Can babies who are likely to develop late-onset VKDB be identified before anything happens? Certain conditions are likely to increase the possibility and babies who have liver disease are known to be more prone to develop VKDB, but liver dysfunction is often not diagnosed straight away after birth and so these babies can be missed. Babies with diarrhoea, coeliac disease and cystic fibrosis also have a greater chance of having VKDB, because they have difficulty in absorbing vitamins, but again these conditions may not be picked up immediately and their increased risk may not be identified.
We know that other babies, without significant medical conditions, can develop VKDB but it is difficult to predict which babies this may happen to. It makes sense that if babies need to receive vitamin K from their food, then any baby who does not feed well may be more likely to develop VKDB. These babies may then have a delay in the establishment of their gut microbiome, resulting in a lag in the production of vitamin K, which could compound the probability of the disorder occurring.
Should vitamin K be given automatically?
So, if there is a risk to babies of developing VKDB and there is a very effective form of prophylaxis, why do we need to talk about this at all? Is it not a no-brainer? Just give it! This, I think, is the perspective that many healthcare professionals come from, but it does not allow parents to fully understand the issue or explore the uncertainties that exist and assess the risk in their personal context.
There are several questions that remain unanswered in relation to vitamin K. For example, could there be some physiological advantage to babies of having lower vitamin K levels that we are unaware of? Could giving babies much higher doses of vitamin K than are physiological be harmful in the short or long-term? We do not know the answers because the research has not been done and is unlikely to do be done. These issues do need studying though, so that we can avoid unintended consequences of vitamin K prophylaxis.
Are there any disadvantages to giving vitamin K?
Should we consider whether there are any drawbacks to giving vitamin K or just accept that if it does more good than harm then that is enough? Any drug can cause problems, from the drug itself to the substances that it is carried in, so does this need consideration from parents? What are the possible detrimental effects of an injection? Does the potential for pain, distress, local infection, nerve damage, bleeding or bruising have any bearing on the decision?
Could the possibility for oral vitamin K preparation to disrupt the gut microbiome and the priming of the baby’s immune system be worthy of a discussion so that parents can try to balance the risks? Does the chance that the baby spits out some of the oral preparation, making it uncertain whether the baby has received an adequate dose, mean that parents are encouraged to view the injection as the only viable option?
Some vitamin K preparations are made using animal products and are therefore not suitable for vegetarians, vegans or others with related dietary requirements and this is not always discussed. However, if parents are aware of this and still want to give vitamin K, they can ask to have an alternative preparation that does not contain animal products, and which meets their individual needs.
What are the alternatives?
If parents are unsure of giving vitamin K are there any alternative approaches they can take? If they are concerned about disrupting the gut microbiome and the priming of the baby’s immune system, but want to avoid the injection, they could choose to delay giving oral vitamin K until the baby has started feeding effectively and the gut microbiome has been seeded.
Alternatively, is watchful waiting a reasonable option? If parents choose to wait watchfully then they need to be aware of how well their baby is feeding, as poor feeding can predispose the baby to VKDB, and to watch out for signs and symptoms of the disorder, which include bleeding, bruising, poor feeding, sleepiness, skin or gums that are paler than before and yellowness in the white part of the eyes after 3 weeks of age.
Parents using this approach also need to know that there are not always early signs and bleeding could occur without warning. In this case prompt action and treatment would be needed. Instead of giving the baby vitamin K, some people take measures to increase the vitamin K levels in their breastmilk and there is evidence that dietary supplements are effective in increasing amounts enough to provide adequate levels of protection to the baby. Currently the evidence suggests that just increasing dietary sources of vitamin K is not enough to raise levels in breastmilk to fully protect the baby from VKDB.
Making informed decisions for your baby
Making decisions for yourself or your baby can seem daunting. Decision-making is very personal and will involve your beliefs, experiences and perceptions of risk. It is vital to have the information you need to be able to weigh up the pros and cons of any intervention and factor in your individual circumstances. An open discussion with your healthcare provider should help you do this and then you can make the decision that is right for you and your baby.