The Vitamin K Controversy
The forces of nature are so focused on a successful birth that it just seems unlikely that all babies are deficient in vitamin K. Instead of simply accepting that nature goofed about clotting factors in newborns, I thought about all the ways that interventions at birth interfere with the normal physiological birth process regarding clotting. The most obvious intervention is premature cutting of the umbilical cord; this deprives a newborn of 25% to 40% of the physiological blood volume, and thus 25% to 40% of the physiological clotting factors that nature intended to be present in the newborn's blood. As someone who does Newborn Screening heelsticks on newborns whose umbilical cords were not cut prematurely (and some of whom did not receive supplemental vitamin K), I can tell you that they have no trouble clotting normally. This solves the problem of early-onset or classical HDN.
Although vitamin K doesn't pass easily from the mother's bloodstream to the newborn through the placenta, it DOES pass easily through breastmilk. (Doesn't this seem like a strong clue that nature is actually protecting the baby somehow by managing the clotting factors in a very specific way?) Women who eat lots of fresh, leafy green vegetables will pass the vitamin K through to their babies, and this will protect them from late-onset HDN.
So, maybe nature got it right, after all, and all we have to do is support physiological health by waiting at least 5 minutes after the birth to cut the cord and by encouraging nursing mothers to eat lots of fresh, leafy green vegetables (or take a vitamin K supplement).
Some exceptions are:
Some maternal medications interfere with vitamin K, such as anticonvulsants, anticoagulants, and antibiotics. [Maternal vitamin K supplementation that is administered prenatally may prevent this form of HDN.
Vitamin K generation is also inhibited in babies who have received antibiotics.
A very few babies will have a liver disorder that prevents the normal production of vitamin K in the newborn's gut; symptoms tend to appear slowly.
Other risk factors include diarrhea, hepatitis, cystic fibrosis (CF), celiac disease, and alpha1-antitrypin deficiency.
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Prophylactic vitamin K for vitamin K deficiency bleeding in neonates (Cochrane Review)
Main results
Two eligible randomized trials, each comparing a single dose of intramuscular vitamin K with placebo or nothing, assessed effect on clinical bleeding. One dose of vitamin K reduced clinical bleeding at 1-7 days, including bleeding after circumcision, and improved biochemical indices of coagulation status. Eleven additional eligible randomized trials compared either a single oral dose of vitamin K with placebo or nothing, a single oral with a single intramuscular dose of vitamin K, or three oral doses with a single intramuscular dose. None of these trials assessed clinical bleeding. Oral vitamin K improved biochemical indices of coagulation status at 1-7 days. There was no evidence of a difference between the oral and intramuscular route in effects on biochemical indices of coagulation status. A single oral compared with a single intramuscular dose resulted in lower plasma vitamin K levels at two weeks and one month, whereas a 3-dose oral schedule resulted in higher plasma vitamin K levels at two weeks and at two months than did a single intramuscular dose.
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Vitamin K at Birth: To Inject or Not By Linda Folden Palmer, DC, author of Baby Matters
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Vitamin K--what, why, and when. [Full text]
Hey E.
Arch Dis Child Fetal Neonatal Ed. 2003 Mar;88(2):F80-3.
"Policies for giving babies vitamin K prophylactically at birth have been dictated, over the last 60 years, more by what manufacturers decided on commercial grounds to put on the market, than by any informed understanding of what babies actually need, or how it can most easily be given. By a pure fluke a 1 mg IM dose, designed to prevent early vitamin deficiency bleeding ("haemorrhagic disease of the newborn") has been found to protect against late deficiency bleeding-a condition unrecognised at the time this policy took hold. Alternative strategies for oral prophylaxis are now opening up (see pp 109 and 113), but these are also, at the moment, dictated more by what the manufacturers choose to provide than by what would make for ease of delivery either in poor countries, or in the developed world."
From the full-text paper:
CONCLUSION - So what have we learnt in the last 64 years? That babies have very limited reserves of vitamin K at birth, and that some will soon bleed if a continuing intake is not guaranteed. We also know that a few "supplements" of cows milk50 or formula milk14 can suffice to restock those reserves, and that there is really no case for giving the healthy, artificially fed, baby further supplementation, either by injection or by mouth, other than administrative convenience. Babies who are not fed, and a very small number of fully breast fed babies, will develop symptomatic deficiency. Without prophylaxis the risk of early (easily recognised) bleeding in a healthy non-traumatised term baby in the first two weeks of life is probably only 1–2 in a thousand. The risk of a later (potentially more dangerous) bleed is perhaps a third of that. Both these risks can be virtually eliminated by giving a single 1 mg intramuscular "depot" injection of phytomenadione, or by giving the baby 1 mg by mouth once a week for the first three months of life. Indeed the only babies not protected by four 1 mg (or three 2 mg) oral doses, if well spaced out, are those with some as yet unrecognised liver disease.36,48
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Vitamin K - An Alternative Perspective
Midwife Sara Wickham provides a much-needed update on vitamin K prophylaxis.
AIMS Journal, Summer 2001, Vol 13 No 2
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From a WHO (World Health Organization) publication - "Care in the first hours includes: . . .
* administering vitamin K to the baby if country policy prescribes it, either by injection or orally. However, the evidence for routine administration of vitamin K to all newborns to prevent the relatively rare haemorrhagic disease of the newborn is still lacking.
It occurs to me that WHO has much more exposure to physiological birth practices than other evidence-based recommendations bodies, such as the Cochrane Collaboration. And given that WHO works on health issues for those who often have very poor nutrition, you'd think they would have noticed problems with HDN or vitamin K deficiency if it were seen in cases where the cord is left intact for a few minutes after the birth.
Sara Wickham's writing points out that HDN or vitamin K deficiency was not reported in the literature before the modern practice of premature cutting of the umbilical cord at birth.
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The purpose of vitamin K is to increase the clotting factors for a newborn. But is that always a good idea?
This web page on Summary
4G/5G promoter polymorphism in the plasminogen-activator-inhibitor-1 gene and outcome of meningococcal disease. Meningococcal Research Group.
Hermans PW, Hibberd ML, Booy R, Daramola O, Hazelzet JA, de Groot R, Levin M
Lancet 1999 Aug 14;354(9178):556-60
Variation in plasminogen-activator-inhibitor-1 gene and risk of meningococcal septic shock.
Westendorp RG, Hottenga JJ, Slagboom PE
Lancet 1999 Aug 14;354(9178):561-3
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Vitamin K for newborns - why & what risks? - from Danny Tucker's pages
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How do Parents Decide about Vitamin K?
If there were absolutely no risks or costs associated with vitamin K administration or the shot, nobody would argue against it.
However, an injection creates an avenue of infection for a newborn with an immature immune system in an environment that contains the most dangerous germs. In addition, the possible trauma from the injection can jeopardize the establishment of breastfeeding, which does much more to protect the baby's health than vitamin K injections have ever been alleged to do. At the very least, the injection should be delayed until after the baby has learned to nurse.
I've sometimes wondered whether there's a connection between vitamin K administration and SIDS. Some studies have shown a lower incidence of SIDS among breastfed babies, and we know that breastmilk is lower in vitamin K. Who knows? Nobody, really. Why are we messing with delicate systems we don't understand?
There is likely a very complex relationship between baby's blood volume (which is reduced by as much as 40% with immediate cutting of the umbilical cord), and the baby's vitamin K and iron levels. It may be that when a baby is allowed to receive all its blood from the placenta, the coagulation factors are more than adequate to prevent hemorrhage.
Given the study that claims that vitamin K levels are not associated with clotting factors, it might be that the best thing parents can do to prevent hemorrhage in newborns is to insist that their babies be allowed to get all their blood back from the placenta after birth. Those would seem to be the clotting factors of greatest use to the baby.
Maybe the association between traumatic birth and newborn hemorrhagic disease is really an association between traumatic birth and early cutting of the cord, which is more likely with a traumatic birth where the baby is rushed across the room for resuscitation. Maybe someday hospitals will develop the sophistication to be able to perform any needed resuscitation without cutting off the baby's oxygen and blood supply.
Until we have the definitive answers to these questions, parents have to choose between a system that's been in place for less than a hundred years and one that's been in place for thousands of years.
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General Discussion about Controversy over Administration of Vitamin K to Newborns
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It has been suggested that if the mother takes oral Vit K, during the last trimester, that there would not be a need for the newborn shot. Anyone know of a study related to this? I have seen a number of clients in this area that choose to take the prenatal Vit K in order to avoid the shot for their newborn.
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There really is little known about the physiologic process of vitamin k absorption and blood factor response. Supplementation was started before the norms were known -- and the dosage was set almost at random (with little research first).
there are a lot of questions being asked now -- especially since it's been found that the IM levels are much higher than needed, and might be harmful.
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Hemorrhagic Disease of the Newborn Really Low Blood Volume from Early Cord Cutting?
Maybe the association between traumatic birth and newborn hemorrhagic disease is really an association between traumatic birth and early cutting of the cord, which is more likely with a traumatic birth where the baby is rushed across the room for resuscitation.
Research
Vitamin K Abstracts
Study Supports Maternal Vitamin K Supplementation for Breastfeeding Mothers as Alternative to Newborn Administration
Vitamin K prophylaxis to prevent neonatal vitamin K deficient intracranial haemorrhage in Shizuoka prefecture.
Nishiguchi T, Saga K, Sumimoto K, Okada K, Terao T
Br J Obstet Gynaecol 1996 Nov;103(11):1078-1084
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Coagulation Factors Not Related to Vitamin K Levels
Vitamin K1 levels and coagulation factors in healthy term newborns till 4 weeks after birth.
Pietersma-de Bruyn AL, van Haard PM, Beunis MH, Hamulyak K, Kuijpers JC
Haemostasis 1990;20(1):8-14
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Plasma concentrations after oral or intramuscular vitamin K1 in neonates.
McNinch AW, Upton C, Samuels M, Shearer MJ, McCarthy P, Tripp JH, L'E Orme R.
Arch Dis Child. 1985 Sep;60(9):814-8.
"One hundred and seven healthy, breast fed infants received 1 mg vitamin K1 either at birth (orally or intramuscularly) or with the first feed (orally). Venous blood samples collected in the next 24 hours were assayed for plasma vitamin K1. In babies given the vitamin orally at birth, the peak median concentration (73 ng/ml) occurred at four hours. By 24 hours median plasma concentrations had fallen to 23 ng/ml and 35 ng/ml in the groups fed vitamin K1 at birth or with the first feed, respectively; this difference was not, however, significant. Plasma concentrations after intramuscular injection exceeded those in the oral groups at all comparable times, with a peak median concentration of 1781 ng/ml at 12 hours falling to 444 ng/ml at 24 hours. Since median plasma vitamin K1 concentrations 24 hours after oral administration were some 100 times and 1000 times greater than previously estimated adult and newborn values respectively, this study supports giving vitamin K1 orally at birth to well, mature babies to protect against early haemorrhagic disease of the newborn. Further studies are needed to determine the optimum dose for protection over subsequent weeks."
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[Effect of oral and intramuscular vitamin K on the factors II, VII, IX, X, and PIVKA II in the infant newborn under 60 days of age] [Article in Spanish]
Arteaga-Vizcaino M, Espinoza Holguin M, Torres Guerra E, Diez-Ewald M, Quintero J, Vizcaino G, Estevez J, Fernandez N.
Rev Med Chil. 2001 Oct;129(10):1121-9.
BACKGROUND: Neonates on exclusive breast feeding that do not receive vitamin K at birth are at higher risk hemorrhagic disease of the newborn. AIM: To compare the effect of oral or intramuscular administration of vitamin K1 (VK1), on clotting factors II, VII, IX, X and PIVKA II, in children until the 60 days of age with exclusive breast feeding or mixed feeding. PATIENTS AND METHODS: Forty healthy full term infants, distributed in two groups, A: 20 with mixed feeding (formula-feeding and breast-feeding) and B: 20 with exclusive breast feeding, were studied. Nine infants of each group received 1 mg of VK1 intramuscularly and eleven 2 mg VK orally 5 ml of cord blood was collected initially from each infant. Venous blood samples were taken on 15, 30 and 60 days of age. RESULTS: All factors increased in a progressive form reaching levels over 50% at 60 days of age, in both groups. PIVKA II decreased significantly during the study period (p < 0.01). Factor II increased more in children with mixed feeding that received intramuscular vitamin K, than in the rest of study groups. No other differences between groups were observed. No infant had an abnormal bleeding during the study period. CONCLUSIONS: Oral administration of vitamin K is as effective as the intramuscular route in the prevention of the hemorrhagic disease of the newborn.
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[Vitamin K 1 concentration and vitamin K-dependent clotting factors in newborn infants after intramuscular and oral administration of vitamin K 1] [Article in Hungarian]
Goldschmidt B, Kisrakoi C, Teglas E, Verbenyi M, Kovacs I.
Orv Hetil. 1990 Jun 17;131(24):1297-300.
Serum concentration of vitamin K1 and activity of vitamin-K-dependent factors II, VII, IX and X were determined before and after vitamin K1 administration in infants. The babies received vitamin K1 intramuscularly or orally. 12 hours after vitamin K1 treatment the mean concentration was increased in the groups receiving vitamin K1 intramusculary or orally, respectively. Serum level of vitamin K1 fell exponentially, the mean half life was about 30 hours in both groups. Activity of vitamin K-dependent clotting factors did not change significantly after intramuscular or oral vitamin K1 administration during the first four-five days of life. It was no direct correlation between the concentration of vitamin K1 and the activity of vitamin-K-dependent clotting factors. This study suggest that oral administration of vitamin K1 is as effective as the intramuscular route. [Remember that prevention effectiveness continues even after the supplemented K levels drop.]
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Vitamin K Protocols
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From Nursing Times, October 14, 1998:
Researchers have found that plasma vitamin K concentrations were at least equal to or significantly higher in babies who are given the new oral form compared to those who are given the vitamin via injection. The oral form is given in doses of 2 mg soon after birth and again four to seven days later. It has been recommended that if the baby is being breastfed, an additional dose be given when it is one month old.
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I have mom take oral Vit. K for two weeks prior to EDD. I find this helps bleeding pp as well. Then I give baby 2 drops at birth (before I leave) and then again on day five.
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I'm curious why you give 2 drops of vitamin K. I was thinking that I would need to give them the same amount of mgs as I would of the synthetic. Do you know more about this, any study on this, or suggested amount. When I worked at a birth center they gave the injectable orally, and it was 50mg. Just wondering what you think about giving the natural vit. K in the same dose.
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I give the same dose PO as is suggested for IM. Some, I have heard, do double the dose when giving it PO.
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we give three doses, following one of the european protocols (birth, one week, three weeks). Not certain whether this is needed or not, but what the heck... perhaps is does extend protection and lessen the low incidence of late onset hemorrhagic disease. The dose is two drops.
How does it taste? I've tasted it! One brand (aquamephytin) tasted rather fishy -- not gawdawful, just not my favorite flavor! babies seem to get down the two drops without flinching.
the brand we've been using for a while is alphalpha-derived (I hear) and doesn't have much taste at all.
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How to Administer Vitamin K Orally
I've seen Vitamin K administered orally as follows: The Vitamin K is drawn up as if for the injection, although you draw up a double dose for oral administration. Once the fluid is in the syringe, you remove the needle. Then you help the baby to be as comfortable as possible, insert the syringe into the side of the baby's mouth so the tip is kind of in the back corner behind the taste buds. Then you slowly push the plunger to push the fluids into the baby's mouth. If done slowly and gently, this doesn't seem to bother them.
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Although this article is about very low-birth weight babies, it's interesting because of the relationship between delayed cord clamping and protection from IVH (Intraventricular Hemorrhage) and LOS (Late-Onset Sepsis). This is the closest information we have about the protective effect of delayed cord clamping against HDN for term babies.
Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial.
Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W.
Pediatrics. 2006 Apr;117(4):1235-42.
RESULTS: Seventy-two mother/infant pairs were randomized. Infants in the ICC and DCC groups weighed 1151 and 1175 g, and mean gestational ages were 28.2 and 28.3 weeks, respectively. Analyses revealed no difference in maternal and infant demographic, clinical, and safety variables. There were no differences in the incidence of our primary outcomes (BPD and suspected NEC). However, significant differences were found between the ICC and DCC groups in the rates of IVH and LOS. Two of the 23 male infants in the DCC group had IVH versus 8 of the 19 in the ICC group. No cases of sepsis occurred in the 23 boys in the DCC group, whereas 6 of the 19 boys in the ICC group had confirmed sepsis. There was a trend toward higher initial hematocrit in the infants in the DCC group. CONCLUSIONS: Delayed cord clamping seems to protect VLBW infants from IVH and LOS, especially for male infants.
Here's the Reuter's version:
Thursday, April 6, 2006
By Clementine Wallace
NEW YORK (Reuters Health) - Waiting 30 to 45 seconds before clamping the umbilical cord of very low birth weight infants -- those weighing less than 1500 grams -- seems to protect them against bleeding in the brain and the development of blood infections later on, researchers report.
The strategy seems to benefit boys especially.
"While countries in Europe tend to wait before clamping these children's umbilical cord, the current practice in the United States is to clamp it immediately after delivery," Judith Mercer told Reuters Health. "There hasn't been a lot of research done in this country on delayed cord clamping, and most studies were limited by small samples."
Evidence is accumulating to suggest that, for very low birth weight infants, delaying cord clamping and lowering the newborn below the mother's level significantly increase the amount of blood flowing from the placenta to the newborn, according to Mercer, from the University of Rhode Island in Kingston.
In their article in the medical journal Pediatrics, she and her colleagues note that waiting 30 to 45 seconds results in an 8 percent to 24 percent increase in the baby's blood volume.
"Immediate cord clamping may deprive these infants of essential blood volume, which might result in hypotension (low blood pressure) and in a poor perfusion of the tissues," Mercer explained.
Her group's study involved 72 pregnant women who gave birth to infants before the 32nd week of gestation. The women underwent either immediate cord clamping at 5 to 10 seconds after the birth, or delayed cord clamping 30 to 45 seconds after delivery.
The researchers saw differences between the two groups in rates of brain bleeds in the babies, and in their risk of late-onset sepsis.
These differences were significant from a statistical standpoint in male infants, but not in females. Specifically, 2 of the 23 male infants in the delayed-clamping group had intraventricular hemorrhage compared to 8 of the 19 in the immediate-clamping group. No case of sepsis occurred among the first group, whereas 6 cases occurred among the others.
The researchers say the strategy is a simple way to improve outcomes of very preterm infants.
SOURCE: Pediatrics, April 2006.
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