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Separating Fact From Fiction in the Not-So-Normal Newborn Nursery: Vitamin K Shots…..

In August, news emerged from Vanderbilt University that four cases of a rare bleeding condition seen in young infants had been diagnosed since February. Three of these infants suffered intracranial hemorrhages, requiring surgical intervention to evacuate the blood and save their lives, although there will almost certainly be neurological and developmental repercussions down the road. The fourth child presented with gastrointestinal bleeding and also survived. The parents of all four babies had refused an extremely safe and effective intervention on the day that they were born, one recommended by pediatricians since the early 1960′s, that would have prevented these outcomes.

When a baby is born, there are a number of rituals that parents and medical professionals take part in. Some are largely ceremonial, more rites of passage than anything medically necessary, such as the first bath or the assignment of APGAR scores. As a physician, I play my part in some of these rituals, the baby’s first exam being the most important. Unlike many medical examinations that pediatricians perform, the newborn exam involves a good deal of showmanship. It’s the only exam where I make a point of talking through each aspect with the parents, showing them all the normal but sometimes surprising (at least to new parents) things that babies do and common physical exam findings that many folks don’t know about and might lead to unnecessary concern. Really hammering home how healthy a new baby is can go a long way towards relieving parental anxiety. And anticipating and addressing common newborn issues during the exam helps save me a lot of time on the back end as well.

Nursing plays the largest role in the rituals of caring for a newborn baby. They give the first bath, change the first dirty diapers and typically assist with the first latch if a mom is breastfeeding. They perform common procedures, such as heel sticks for newborn screening and jaundice assessments if necessary. They really do a lot, providing a great deal of vital education for parents while doing it, and their role in the care of the newborn far outshines my contribution for the majority of healthy babies.

Another ritual that nursing plays a major role in, and one that has significant medical benefits associated with it, are vitamin K injections. But before I discuss why it is so important for newborns, especially those that are going to be primarily breastfed, to receive these injections, a little primer on vitamin K is in order.

What is vitamin K?

Vitamins in general are organic substances that are necessary for normal metabolic processes that cannot be made by the human body. We have to take vitamins in by eating foods that contain them. The beginning of our understanding of vitamin K goes back to 1929 when Danish researcher Henrik Dam discovered that a substance existed which could help correct bleeding induced by restricting cholesterol from the diet of chickens. This substance, named Koagulationsvitamin in the German journal that first reported the findings, has since been known as vitamin K. The fat soluble vitamin K was first isolated from alfalfa sprouts only a year later.

There are two main forms of vitamin K. We take in vitamin K1 when we eat leafy green vegetables like kale and spinach, but it is also found in broccoli. Because it plays a major role in photosynthesis, it isn’t found in root vegetables in large amounts. Vitamin K2 can also be obtained from the diet, usually in the form of aged cheeses, fermented vegetables and organ meats. Much of the vitamin K2 in our bodies is actually synthesized by bacteria in our intestines and then absorbed. In general, vitamin K1 is the most active form.

In order to absorb vitamin K, we need a functioning pancreas and biliary system. The vitamin K that we take in is bound to proteins that require pancreatic enzymes in the small intestine to be broken down. Bile salts then render the liberated vitamin K able to be absorbed into intestinal cells for processing and transport to the liver. So biliary and pancreatic disease can increase the risk of deficiency, which is actually quite rare in adults. Babies, now that’s a different story as I’ll soon explain.

What does vitamin K do?

The primary role of vitamin K in the human body is blood clotting. It is also involved in bone growth and density, but at this time there isn’t great evidence that supplementation is particularly helpful in preventing osteoporosis or fractures. In some countries, however, various formulations of vitamin K have been recommended for just that purpose. There is ongoing research into vitamin K’s role in the development of Alzheimer’s disease, heart disease and even some cancers, but these are hypothetical and may not pan out.

Vitamin K is a cofactor necessary for a number of key enzymes involved in clotting to work properly. In particular, clotting factors VII, IX, X and prothrombin produced in the liver require vitamin K-fueled activation. Without enough vitamin K, ultimately these proteins will not be attracted to circulating platelets and blood clotting will be impaired, which can lead to life-threatening bleeding complications. The medication warfarin takes advantage of this by blocking the conversion of inactive precursors into active vitamin K. This is why patients on warfarin are warned to avoid excessive dietary vitamin K intake as that may reverse the anti-clotting effects.

Why do babies need vitamin K shots?

Newborn infants are considered to be universally deficient in vitamin K. This happens for a variety of reasons. There is poor transfer of vitamin K across the placenta and the immature liver has both decreased storage capability and is inefficient at using available vitamin K. Naturally, this is even more pronounced in premature infants. Adding to this, breast milk does not contain sufficient amounts of vitamin K and the initially-sterile gut of the newborn does not significantly contribute to vitamin K levels in the body for several weeks.

There isn’t anything a mother can do about these etiologic factors. But some things can add to the risk even further. There are a number of medications, in particular warfarin and some anti-seizure drugs, that when taken by a mother during pregnancy increase the risk of vitamin K deficiency and bleeding complications in the new baby. Certain antibiotics used to treat tuberculosis can have a negative impact as well.

Without supplementation, newborns are at risk for a potentially devastating condition known as vitamin K-deficient bleeding (VKDB), formerly known as hemorrhagic disease of the newborn. VKDB is a better designation because life-threatening bleeds can occur as late as 3 months of age, particularly in breastfed babies who did not receive an intramuscular dose of vitamin K on the first day of life. Most bleeding occurs during the first week, however.

The really scary thing about VKDB is that it occurs in perfectly healthy babies and it happens spontaneously, not because they were dropped on their head for instance. Bleeding can present in many ways, ranging from mild to fatal. Skin bruising, bleeding into mucosal tissues (mouth, nose, throat, intestine, uterus, urethra), bleeding at the umbilical stump or circumcision site, and bleeding into the brain can all happen.

One of the most common presentations of easy bleeding in newborns is something called a cephalohematoma. These are bleeds under the periosteum, a dense connective tissue membrane that covers bone, and typically involve the parietal bones of the skull because of pressure to the scalp during even uneventful deliveries. Because the blood is trapped under the periosteum, these present as immobile but squishy (think silly putty) scalp masses, sometimes shockingly large, that can take weeks to resolve. Large cephalohematomas are a major risk factor for severe jaundice.

Without supplementation, as many as 1.7% of babies would be expected to have some kind of bleeding complication during the first week. This is known as “early VKDB” or classic hemorrhagic disease of the newborn, and it can be easily prevented by an intramuscular vitamin K injection on day one of life. It can also be prevented with oral supplementation. The evidence to support the efficacy and safety of these interventions is rock solid, but there are problems with oral supplementation when it comes to bleeding after the first week.

When there is a bleeding complication from vitamin K deficiency that occurs between 2 and 12 weeks of life, this is called “late VKDB.” This happens almost exclusively in babies fed primarily breast milk who did not receive adequate vitamin K prophylaxis, or who have some other major risk factor such as liver disease or cystic fibrosis. Late VKDB, as it did in the children treated at Vanderbilt Children’s Hospital, where I completed my pediatric training and a fantastic facility by the way, tends to present as unexpected bleeding into the brain.

The risk of late VKDB is felt to be around 4.4 to 7.2 per 100,000 children not receiving vitamin K prophylaxis. Oral vitamin K given on day one of life does not substantially reduce the risk, while intramuscular dosing renders it virtually nonexistent barring some other significant risk factor. Some countries promote longer-term oral vitamin K prophylaxis, and there are a variety of approaches. One common method is to dose vitamin K orally with the first feed and again at one, four and eight weeks of age. In the Netherlands, small daily doses have been recommended. While not every approach to oral prophylaxis has been extensively studied, such as the small daily dose regimen, many have been and it appears that there remains a risk of about 1-2 cases of late VKDB per 100,000 births.

Why would oral prophylaxis not work? There are just too many variables. Adherence to the recommended regimen may be poor for a variety of reasons. A child may be ill and vomiting, or on antibiotics which interfere with gut production by killing off intestinal flora. A family may simply forget. The amount of vitamin K in the breast milk may be affected by external factors as well. So while oral vitamin K may be cheaper and does not cause any procedural discomfort, and it may be better than none at all, the evidence supports intramuscular prophylaxis, especially when you consider the potential outcomes of late VKDB. Some countries that switched to oral regimens have seen spikes in the incidence of late VKDB, and Australia switched back to intramuscular. Of note, premature infants must receive intramuscular dosing because of poor absorption of oral formulations. Also, liquid oral vitamin K is not available in the United States.

Why would a family refuse vitamin K?

I imagine that regular readers of SBM are not surprised by the fact that vitamin K prophylaxis refusal is something that pediatricians and family practice doctors deal with, although not as frequently as vaccine refusal. Why do parents do it? Why would a parent reject an intervention that is so effective at preventing such a devastating consequence as bleeding into the brain of their baby and a potential lifetime of seizures, developmental delay and cognitive impairment? And one that is virtually risk free to boot!

Many families who refuse simply have a world view where medical intervention is perceived as unnatural. Many of these children are born at home or in birthing centers attended by midwives and doulas. They tend to have extensive and demanding birth plans when they deliver in the hospital and frequently also refuse antibiotic prophylaxis against neonatal conjunctivitis, another newborn ritual with less controversy attached to it. Eye and vitamin K prophylaxis are collectively referred to in nurseries as the “eyes and thighs”. These families also typically refuse the newborn hepatitis B immunization, perhaps a topic for another post, and go on to refuse or spread out childhood immunizations in the future.

Though not as widespread as anti-vaccine propaganda, and certainly lacking that particular entity’s infrastructure and celebrity support, there is an online presence of bogus anti-vitamin K information to be found. Naturally the chiropractic community is all over the place about this topic as they are with everything else. This particular practice warns that synthetic intramuscular vitamin K might cause cancer, kill your baby, or make them sterile, and questions the need for prophylaxis at all.

In March of 2010, our friend Dr. Mercola interviewed biochemist Cees Vermeer, who appears to be an expert on vitamin K who is involved in research to find new commercial applications, and published an article on the subject of newborn vitamin K prophylaxis that questions the mainstream approach. I also found several message boards and mommy groups citing this information as a reason to question the intramuscular injections. I’ll start off with what the article gets right. He appears to appreciate the need for vitamin K in newborns, and discusses some of the risks of deficiency. He is absolutely right when he says that newborns can feel pain, and that pain in the neonatal period can sometimes have long lasting effects. He is right when he says that oral vitamin K prophylaxis can be effective. Maybe I’ve been too hard on this guy.

I was shocked to find that Mercola even agrees with mainstream science that intramuscular vitamin K prophylaxis does not cause cancer. Because of some small, poorly done studies in the early 1990′s there was a brief period of concern that vitamin K prophylaxis increased the likelihood of pediatric leukemia. The question was thoroughly addressed by better studies and is not considered a problem. However it does occasionally come up as a reason to refuse, or as something that parents are worried about and want to discuss. For more information on this non-controversy, here is the AAP policy statement.

So now let’s tackle what Mercola gets wrong. I’m not sure how much of this represents his versus Vermeer’s understanding of VKDB, but they don’t appear to have a good understanding of it. He makes some pretty glaring mistakes (I’m being generous) in the article that are easily addressed. First off, he doesn’t seem to understand the differences between early and late VKDB. He mentions the risk of up to 1.7%, but not that this specifically is for the early form. He then declares that this is rare. I do not consider almost 2 out of every 100 births to be rare. The incidence of late VKDB is considerably lower and could reasonably be thought of as rare, but when it happens it usually results in a messed up brain. If nearly 2 out of 100 kids had brain bleeds, that would be horrific!

He states that there was no evidence to support the standard of care in regards to vitamin K prophylaxis when it was first implemented. Vitamin K became a routine standard of practice in 1961. I was able to easily find numerous papers going back a decade before that investigating the use of vitamin K prophylaxis in newborns. He likens what we do to a “shotgun approach” that was convenient. You know what is inconvenient? Brain bleeds.

He blames increased rates of circumcision on the push to give intramuscular vitamin K injections. This is absurd. It has been known for decades that oral prophylaxis is just as effective as intramuscular for early VKDB. Most circumcisions take place on day 2 or 3 of life. Intramuscular injections are recommended only because they work better than oral regimens for preventing bleeding complications in the 2nd to 12th week of life.

So why is Mercola so worked up about vitamin K? He just cares too much, I suppose, and can’t bear to think that newborn babies might be suffering from the pain of an intramuscular injection. Anyone who read my last post on pediatric pain should know how much I hate poorly managed pain, but even I think his concerns are over the top. Mercola likens the discomfort from an IM injection of vitamin K to psycho-emotional damage and trauma that causes an “emotional wound that the helpless and innocent baby needs to overcome to achieve health and wellness.”

Poorly managed pain in the neonate does have potential downstream repercussions. I really do need to go into more detail in a post on the subject. But to compare a one-time IM injection to a 25-week-premature infant riding a vent without appropriate pain control for 5 weeks, or twenty heel sticks over the first few days of life to follow blood sugars in the growth-restricted infant of a diabetic mother, is more than a little ridiculous. Untreated bouts of acute pain in neonates, such as a circumcision without any local anesthesia or sugar water, may increase their pain/stress response to future painful events in infancy such as routine childhood immunizations, but they do not “remember it” or have psychological problems further down the road. Infants who suffer chronic pain, usually premature babies that require mechanical ventilation and/or surgery, have actually been shown to have a blunted pain response. We don’t have good data on longer term issues regarding chronic pain in babies.

Mercola raises concerns about the safety of the dose of intramuscular vitamin K, stating that it is 20,000 times the needed dose. His source is “givingbirthnaturally.com.” Even if true (the needed dose for what?), he acts as if it is being injected straight into a vein. It is an intramuscular injection. The vitamin K is slowly metered out similar to penicillin shots that we give in place of lengthy courses of oral antibiotics for strep throat or the prevention of rheumatic heart disease flares. He worries about toxic preservatives injuring the baby’s immune system but gives no evidence to support this because there is none.

He mentions that an injection is an infection risk because the baby has an immature immune system and hospital bugs are so dangerous. This is theoretically true but the risk would be considerably lower than the risk of bleeding in a child not appropriately prophylaxed against VKDB, and he cites no data to support his concern. Intramuscular injections do have real risks, but they are very minor. A bruise or treatable local infection, for instance, must be weighed against the risk of a brain bleed.

Mercola recommends oral vitamin K as an equally effective alternative to the intramuscular dose. He says it is absorbed efficiently enough and there is no risk of overdosing or a bad reaction. He claims that oral dosing is even equivalent in exclusively breastfed babies, which is potentially very dangerous advice, but then says that future research is needed to find better “pinpoint guidelines.” Well, we have current research that says most oral regimens are less effective and we lack evidence to show that daily dosing is as effective as intramuscular injections for preventing late VKDB. If future evidence shows daily dosing to work as well as injections, then it may be a reasonable approach in some infants. But to completely ignore the fact that giving a medicine orally to a baby for long periods of time is prone to adherence issues shows his lack of any true understanding of this topic or of babies.

He quotes Vermeer as saying that if breastfeeding women just eat enough foods rich in vitamin K, their babies don’t need the intramuscular injection or the oral supplementation. Levels of vitamin K in breast milk are low, much lower than in infant formula, and it is not clear at all if dietary modification is good enough. And if a mother goes on a course of antibiotics, for instance, or is ill and unable to eat a diet high in green leafy vegetables for a period of time, her vitamin K levels may decrease and put the baby at risk for a bleed. Vermeer is a biochemist, not a physician and I would ignore his advice on the matter. I would ignore what Mercola has to say about this and everything else.

Conclusion

Newborn babies are amazing things. I don’t pretend to know everything there is to know about them, and I certainly don’t understand the evolutionary underpinnings of vitamin K deficiency in newborns. I guess it is uncommon enough that there was no pressure to evolve better transport of vitamin K across the placenta or to increase levels of vitamin K in breast milk. But the why is not so important in this instance. Babies, through no fault of their own, are born at increased risk of life threatening bleeding complications from vitamin K deficiency. Vitamin K prophylaxis via the intramuscular route is safe and effective at preventing these life threatening complications, and based on the evidence available it is better than oral regimens. This may change in the future.

When a parent refuses the vitamin K, I can’t force it upon them. I try to get to the bottom of their concerns and address them as best as possible. In the vast majority of instances, parents agree to the injection. When they don’t, we don’t notify child protective services or call the police. We document, document and then document some more so that it is clear in the medical record that the parents were given the appropriate information to make an informed decision and that even knowing the risk they still refused. There is no oral vitamin K solution available in the United States, but I guess you can get anything on the internet these days. Oral dosing is better than nothing. I leave that discussion up to their primary care physician.

Posted in: Science and Medicine

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43 thoughts on “Separating Fact From Fiction in the Not-So-Normal Newborn Nursery: Vitamin K Shots…..

  1. Bob says:

    Nice article especially the facts on vitamin K lots of vital info. Surprising to learn the relation between the vitamin and infants. I had n o idea vitamin K was so far reaching, or the lack of. Thanks for sharing such knowledge and expertise.

  2. windriven says:

    Great column but it leaves me with several questions. What does the dose curve for IM vitamin K look like and how long does it last? In a perfect world would vitamin K IM every x days be better than a single dose?

    There seems to be a significant difference between breast and formula fed babies apparently owing to vitamin K supplementation in infant formulas. Doesn’t this militate for supplementing the IM loading dose with oral vitamin K during the first 12 weeks of life?

    1. windriven says:

      Sorry, should have said:

      Doesn’t this militate for supplementing the IM loading dose with oral vitamin K during the first 12 weeks of life for breast fed babies?

      1. Angora Rabbit says:

        In addition to Clay’s answer, VK is relatively non-toxic; there is not even an Upper Limit for intake because it has been impossible to find/demonstrate. So risk of combining IM and formula VK forms isminimal. Perhaps because liver is very good at clearing and storing VK.

    2. WilliamLawrenceUtridge says:

      Vitamin K is fat soluble, so once it’s in the body, it would presumably be sequestered into fat stores and released relatively slowly over time; that’s probably why a single IM bolus is enough to carry the kid until their gut can start coming online.

  3. Clay Jones says:

    Late VKDB while not impossible is almost unheard of after the one IM dose. It’s also very rare in setting if formula fed kid, but I couldn’t find numbers on that. It’s best to give the shot because of the chance if something interfering with oral intake. What if formula fed kid, who didn’t get the IM dose, is hospitalized at 2 weeks and on IV fluids for a few days? Or longer? What if they end up having biliary or liver disease, or require long courses of antibiotics? Just too many variables. Benefit of IM far outweighs risk.

    1. windriven says:

      “Late VKDB while not impossible is almost unheard of after the one IM dose.”

      That is what prompted my (awkwardly worded) question on serum levels of vitamin K over time after IM. Apparently either the serum levels stay elevated for a lot longer than I would have guessed or the injection ‘kick starts’ a process that continues with limited or no supplementation. Just curious if it is one of those, something else, or if we even fully understand the process.

      And this was purely a mental exercise not intended to question the importance of the IM. The risk/benefit clearly supports the IM.

  4. Jeremy Praay says:

    Those who are very familiar with false accusations of alleged shaken baby syndrome, are very aware of the benefits of vitamin K injections. As you point out, oral doses are not as effective, although they are probably better than nothing.

    There were a couple of cases in which Dr. Holmes Morton became involved, which you can read about here: http://articles.philly.com/2007-10-28/news/24996310_1_tour-guide-lucas-latin In case you feel that Dr. Morton may have been (perhaps unknowingly) supporting the abuse of children, it’s worth noting that Dr. Lucy Rorke-Adams was involved in both of these cases, and she is a very strong proponent of the SBS diagnosis.

    1. Delphine says:

      I was left with a similar question re: possible abuse allegations. Many years ago as a social worker I was involved in a situation where the infant had several subdural hematomas and it were determined to be abuse by a doctor who specializes in child abuse. A very thorough investigation by the DA was done and the evil-doer was not discovered and the usual suspects were ruled out. I always wondered, and still wonder at times, if something else could have been going on. It was a rather scary situation.

  5. irenegoodnight says:

    I don’t want to bore regular readers, but I had three of my four children at home with no attendant for one and a nurse midwife (nun) at the other two. My reasons had nothing to do with the current crop of woo-oriented anti medicine/vax crop. I simply have precipitous delivery and did not want to end up delivering in a car on the way to a hospital. All three were inspected by a pediatrician within hours of birth–we happened to have one across the street with the first. Also, as my eldest is 44 years old, I can tell you that birth in a hospital in 1969, was enough to make anyone never want to do it again, so yes, that was also a factor.

    We got the Vit K shot and had the PKU test, but did not have the eye drops or circumcision (all the born-at-homes were boys). My question is this: Why would evolution result in babies being born without adequate Vit K? Most are not I take it, so is this just a case of treating everyone to catch the few with a “flaw”?

    1. Harriet Hall says:

      There is not always an answer to “why” questions about evolution. Some undesirable traits are eliminated by survival of the fittest, others persist because they are linked (close to each other on the chromosome) to beneficial genes, or because of chance occurrences.

    2. Angora Rabbit says:

      Irene, that’s an easy one. Humans evolved on a “filthy” diet and opportunities for colonizing the gut could well have been greater than for today. Infant is carried, constantly nuzzling the breast, and getting microbial exposures. Skin-skin contact instead of clothes would facilitate that, too. Many evolutionary pressures go back on the tens of thousands time scale, not the short time scale of civilization.

      And we’re talking about a small % of infants at real risk for the bleeding disorder, so again there’s that evolutionary tradeoff. Presumably that change may have conferred some benefit to have been stabilized in heterozygotes – lower stroke risk? I dunno.

      For Mr. Marcola, note that breast milk VK content is NOT affected by typical food intakes. One needs pharmacological doses to increase the milk content, which does not sound like “natural news” to me. So “eating more VK rich food” ain’t gonna cut it because breast milk doesn’t work that way.

      Vermeer is a respected VK researcher, though his recent focus is VK and CVD/calcium, not metabolism and infancy. I wonder if he was misquoted? I had that experience once with “Prevention” magazine. Sometimes (I am being charitable here) people hear what they want to hear, not what was said.

      The oral route concerns me. Gut absorption is not going to be efficient on an oral bolus, so then the oral dose has to be even higher to compensate. Perhaps it is multiple doses over a period of weeks? The beauty of IM is that, being slow release, one avoids the big serum bulge that comes from oral dosing. Since the IM is more efficacious than oral, I wonder if the difference is cultural?

      1. Clay Jones says:

        Oral is just cheaper and considered “easier” is what I have been able to gather. I believe that many countries were going the IM route and then switched, and now some are switching back because of spikes in the occurrence of late VKDB.

        He may have been misquoted. I don’t trust Mercola as far as I could throw him.

    3. WilliamLawrenceUtridge says:

      Evolution is a “good enough” process anyway, it doesn’t work to maximize individual-child survival. Nature doesn’t give a shit if you lose a dozen kids, so long as two or three survive.

  6. Wendy Haaf says:

    I had no idea the risk was that high, even without circumcision, forceps delivery, etc. Had I known that 20+ years ago, I probably would’ve opted to give kids the shot. (And this is coming from someone who had two – out of three – births at home with midwives, and refused eye prophylaxis, though all three kids received all vaccinations that were recommended at the time.

  7. mousetharoared says:

    “Why would a family refuse vitamin K?

    I imagine that regular readers of SBM are not surprised by the fact that vitamin K prophylaxis refusal is something that pediatricians and family practice doctors deal with, although not as frequently as vaccine refusal. Why do parents do it?”

    Sometimes I wonder if medicine is a victim of it’s success. I wonder if people avoid preventative measures because they believe that medicine has such a high success rate of dealing with these dangerous situations and they don’t understand how involved and risky relying upon treatment rather than prevention is.

    As an example (although not a direct comparison) I’m often told by folks how easy it is these day to correct congenital birth difference such as cleft lip/palate, heart defects, etc. But, they don’t really seem to understand the amount of work or time that goes into correcting even some of the less dangerous differences.

    I wonder if in the back of their minds, these parents are thinking – first that it won’t happen to them and second, if it does happen, they can just rush the child to the E.R. and everything will be okay.

    1. Nashira says:

      Surgical correction is “easy”? That boggles my mind. Admittedly, the mandibular prognathism that runs in my family is something that, when it requires surgery (like my pretty significant deformity did), has to wait til adulthood to be fixed, but… man, it was not easy at all. Easier than it was when my mom had a similar surgery 2 decades before mine, yes of course, but dude. If we could have prevented the deformity in the first place, we would have been all over it.

      The end result of the surgery is great (I can chew food and my teeth make full contact!) but the orthodontics, the surgery itself, the recovery, the physical therapy, the lingering neuropathy… it would have been wonderful to avoid them.

      1. mousethatroared says:

        Yeah Nashira, I think people see the before/after photos and they see miraculous results. They don’t see the many of hours of therapy, visits to doctors, orthodontist, dentists, surgeries and repeated testing, that may go into getting those miraculous results.

        On the other hand, It is true that congenital differences that used to be disabling are no long so, with appropriate care. That information is really important…Just good to keep things in perspective.

  8. confused says:

    Dr Jones, do you have to get informed consent before the nurses give the IM injection? In adult medicine, if a patient is hospitalized, we do not get consent for each and every little diagnostic and therapeutic maneuver we perform (e.g. administering antibiotics, drawing tests for bloodwork, etc). I am surprised that in your hospital the parents are being asked whether or not to permit the IM injection of vitamin K. It seems like such standard care. Or is it just that some parents come in with a little bit of foreknowledge (not enough obviously) and ask the nursing staff not to give this shot?

    I find the whole thing rather bizarre. If you are going to deliver your baby in a modern hospital environment, you should expect to get hospital-based care, including all the standard operating procedures. There shouldn’t really be much opportunity to demand otherwise. If a patient asked you to inject them with contaminated sera, you, as a physician, have every right to refuse (on the basis of causing harm). So by that logic you should be able to countermand the parent’s request that you not inject their infant with vitamin K (on the basis that not to do so is causing harm). One is an error of commission, the other is an error of omission, but I really don’t see the difference. If someone’s child came in for an acute infectious illness that was 100% fatal without antibiotics (e.g. sepsis), demanded hospital care for their child but refused to allow you to give lifesaving antibiotics, how would you handle such a situation? Although this analogy is a bit of a stretch, there are commonalities.

    1. mousethatroared says:

      @Confused – You don’t think it’s a good idea for doctor’s and hospitals to get informed consent from parents on medical procedures for their children because a tiny minority of the parents may make a poor decision?

      What about doctor’s and nurses….they never make mistakes or poor choices? The parents may not even be that familiar with the doctor in charge. What if he’s some loon who thinks “Standard of Care” is using his latest patented treatment on newborns to prevent neonatal chronic lyme (or some such)?

      1. Nashira says:

        MTR, that’s a terrifying idea. Do not want. :(

        1. Nashira says:

          …phone HTMfail. Was trying to quote:

          “What if he’s some loon who thinks “Standard of Care” is using his latest patented treatment on newborns to prevent neonatal chronic lyme (or some such)?”

      2. Confused says:

        If doctors had to obtain informed consent (even verbal) for every single diagnostic and therapeutic maneuver – even those as risk-free as IM vit K – they would never be able to practice medicine. It would literally bog the system down. The maneuvers that require informed consent typically have some sort of risk associated with them and requiring weighing of risks and benefits by the patient and provider (in consultation). I do not think vitamin K given parenterally is anywhere close to that. I don’t know for certain, but I’m fairly confident this therapy is routinely given without asking for consent.

        1. mousethatroared says:

          @confused – If it’s routinely given without consent, then why wasn’t it given in these cases?

          By the way, it would help if you were a bit more specific. First your rational for not getting consent was that it’s “standard operating procedure” then you seemed to think consent wasn’t needed when it was dangerous not to do the procedure (without outlining a required standard for what was considered too dangerous) , now you don’t think consent is needed because the risks of IM vitK injection are low.

          I’ve never had a newborn baby, but I do know I’ve had to sign consent forms for my children’s blood draws…also a low risk procedure.

          Usually for procedures like surgery the involved parties (surgeon, anesthesia) run you (the parents) through the likely scenarios and you give consent for them and aknowlegement that the medical personal may need to do additional procedures in an emergency.

          I suspect it’s similar with newborns, parents give consent to a checklist of the standard tests and procedures…but I’m sure there’s lots of people who have more experience in that department than me. :)

    2. Clay Jones says:

      In regards to vitamin K injections, I’m sure that parents sign somewhere allowing it but it is probably buried in a slew of other consents. We only discuss it with families when they refuse. And parents generally have to be clear before delivery that they do not want it given, as it is usually given very soon after delivery.

      As pediatricians we have the right to provide emergency care for immediately life threatening conditions. If a child comes in bleeding out because of a gunshot wound, it is irrelevant if their parents are Jehovah’s Witness. For other things, even those that are life threatening but not immediately so, it can be tricky and the courts are sometimes involved.

    3. lookatherglasses says:

      I have a nine week old, and I only recall being specifically asked about consent for the Hep B vaccine and for a card that the hospital will give you with a DNA sample for you to keep. I actually wondered if they’d ask since I had read about the issue of refusal and didn’t recall them asking with my first.
      There was a huge pack of papers to sign, although frankly since I came in already in active labor and was ready to push by the time the nurse had asked me the 5,001 admission questions, all that stuff was actually completed after the fact. (Including permission for my OB to deliver the baby.)

  9. Peter Meeus says:

    In Belgium the IM preparation is also used for oral administration (Konakion® Roche)

  10. Becca says:

    This post breaks my heart for two reasons. First, I missed out on all the rites of passage written about after I gave birth. Second, because parents needlessly put babies at risk while trying to do what they feel is best for their babies.
    Unfortunately, people are unaware of the maladies preventive medicine saves babies from. This ignorance is mixed with fear mongering fallacies that are circulated and has sad consequences. It is a frustrating predicament: How does one educate the public with facts when so much misinformation is in circulation coming from “trusted” sources?
    For children’s sake, I hope the rebel against medical science attitude or trend fizzles out quickly.

  11. irenegoodnight says:

    Thanks for all the responses about my evolution question–all things I would have known had I reached far enough into the memory banks. I’m not ignorant, just getting “dim”. :-)

  12. Carolyn says:

    From the St. Louis Post Dispatch:

    “Four babies hemorrhage after Parents refuse Vitamin K shot, a practice on the rise.”

    http://tinyurl.com/l865fl8

  13. Ausduck says:

    Although the Vit K IMI at birth is not as focussed on by the antivax groups out there as vacinations themselves are, those groups are still responsible for promoting fear and misinformation to the extent that some of their supporters include Vit K with newborn Hep B vaccination as unnecessary medical interventions at birth.
    The Australian Vaccination Network until recently at least had Vit K included on their ‘vaccine factsheets’ page on their website, with all of the ‘mother’s milk is best and adequate’ tropes that Clay discusses from Mercola.

    As to consent for the Vit K injection, the level of consent would differ from facility to facility, and indeed country. There is a specific consent form for the injection here in my neck of the Australian woods, for example, as the Obstetrics/Neonate area is the most litigious. The rule of thumb is if it’s invasive, consent is required. As to other procedures such as medications, or cannulation, the consent can be verbal – and the medication/minor procedure can (and has been) refused.

  14. NorrisL says:

    Why would any concerned parent refuse a Vit K injection after having the reasons and indeed necessity for the injection. Oh, that is why. Because at times we are dealing with people who can rightly be described as idiots. They have the information presented to them, they are informed of the minor risks and of the urgent NEED for a Vit K injection and yet some “intelligent adults” (?) refuse.

    I have a saying. You can’t deal with idiots!

  15. Jessica says:

    Great post! I have a question about this portion:

    “some anti-seizure drugs, that when taken by a mother during pregnancy increase the risk of vitamin K deficiency and bleeding complications in the new baby. ”

    I’m currently, and newly at 9 weeks, pregnant with our second and I’m taking Lamical, as I did with my first pregnancy. Is there anywhere I can read about the specific medications were there may be a concern? My son was perfectly fine after birth, received the VK shot, etc, so I’m assuming that the shot reduces the risks associated with the medication. I probably don’t need to be concerned with it at all, but I liked to meet my docs part-way, since they do have other patients than myself. ;)

    In general, I just like to read up on these things as much as possible. I trust my psychiatrist, my doctor and the doctors and staff at UW Medical in Seattle, where I’ll deliver, are fabulous. But I still take responsibility for educating myself as much as possible. I don’t expect them to have special powers to divine every little detail in my life! :D (Sorry if this is rambly – first trimester + three-year-old in the house = no brain power!!)

  16. AHodges says:

    Mercola is a f’n menace.

  17. Skeptical says:

    Vitamin K: a flaw in the blueprint? – Sara Wickham :

    “Was the cord cut quickly, or was the baby allowed as much time as she needed to regulate the amount of blood she would keep? What difference does this make to the amount of clotting factors and other relevant components in the baby’s blood? ”
    http://sarawickham.files.wordpress.com/2011/10/a1-vitamin-k-a-flaw-in-the-blueprint2.pdf

  18. On thing to consider is,
    in a healthy baby since when did need of vitamin K shots evolve into action. Hadn’t nature planned anything to acculmulate adequate vit K in babies.
    Sometimes we over do things is what I feel. Just a personal opinio.

    1. Chris says:

      You might want to take a basic biology course if you think “nature” is sentient enough to “plan.”. Though you might want to read the above article more carefully, especially this sentence: “The risk of late VKDB is felt to be around 4.4 to 7.2 per 100,000 children not receiving vitamin K prophylaxis.”

      We did not evolve, medical science has advanced. A century ago infant mortality was very common. That has been reduced for several reasons. One of the many reasons was the discovery of vitamins, including Vitamin K.

      Do you think the risk of 4.4 to 7.2 per 100,000 babies bleeding to death is minor? If so, then please explain what you think are acceptable risks.

    2. WilliamLawrenceUtridge says:

      Evolution works on a “good enough” principle. Basically, if something doesn’t have a strong selective pressure either way, it will at best be filtered out of the gene pool only over extremely long stretches of time. Far, far worse design features exist because they are “good enough”, ones with what would seem much more intense selection pressure. For instance, ever choked while drinking? We’re just about the only mammal to do so, because our throat uncomfortably mixes the breathing and swallowing tubes. Yet we haven’t evolved a parallel tube system to separate breathing and swallowing.

      Also consider this – the death rate is around 0.004%. That’s a pretty weak death rate, particularly considering how many babies have died of other things in human history, and the numbers of humans that existed when this would have been the strongest selection pressure (when we only numbered perhaps in the hundreds of thousands). Not to mention Angora Rabbit’s comment about how filthy humans were before, and therefore how many more gut bacteria would have been “available” to babies in centuries past.

      So perhaps a better way to think of it than “selection pressure” and evolution is that we can, through a virtually no-risk intervention, prevent the deaths of a tiny percentage of babies for whom this might have been a problem. Of course, it may seem like an invasive act, injecting all babies to save a few – but if yours is one of the few, it’s kind of a big deal.

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