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Info Sheet: Newborn Vitamin K Shot/Oral Dose

Posted on October 4, 2013 at 3:39 PM Comments comments (285)
Here is another installment in our Information Sheet series.  These info sheets are designed to give you information as a starting point for your own research to decide what is the best choice regarding this option for your family.  We are not medical experts or care providers.  We are informed consumers who want to help other families make informed consumer decisions when they say "YES" or "NO"
Definition: Newborn Vitamin K Shot/Oral Dose
A single injection containing .5 to 1 milligram of vitamin K is given in one of your baby’s thighs.
An oral form of Vitamin K was finally developed in the late 1990s and is now available for parents who prefer to give Vitamin K to their baby orally.
In 2003 the American Academy of Pediatrics recommended that vitamin K1 should be given to all neonates as a single, intramuscular dose of 0.5 to 1 mg29, and this recommendation was recently reaffirmed in 2009.
Why was it developed?
Research in 1937 found that prothrombin times (PT, the time required for blood to clot) in normal neonates were between 30-60% adult levels, falling to 15-30% on day two, and then gradually rising again until about day 10.  This research led to the continuing belief that these low levels in the newborn are a deficiency and need to be corrected.  
In 1939, vitamin K was isolated from alfalfa by Dam, for which he later received the Nobel Prize, along with Edward Doisy, who isolated vitamin K. Further research in 1939 by Waddell and Guerry found that low plasma prothrombin levels could be elevated by the administration of oral vitamin K.  
What was it supposed to treat?
"Armed with this 'proof' that vitamin K deficiency caused HDN (Haemorrhagic Disease of the Newborn) now known as VKDB (Vitamin K deficiency-related bleeding), vitamin K was synthesized and various trials were commenced to ascertain which was the most effective amount and route to use in prophylaxis.

It is difficult for us to assess these trials nowadays as they were mostly neither double blind nor well controlled.  The dosage of vitamin K given, the route of administration and the time of administration all varied.  In many cases, the conclusions did not seem to match the results.  
Occurrence of vitamin K deficiency bleeding (VKDB) in the first week of the infant's life is estimated at 0.25 to 1.7%, with a prevalence of two to 10 cases per 100,000 births."
"Some of the studies assessed the effect on neonatal vitamin K levels if the mother was given vitamin K during labour. Results varied, with the effectiveness of the vitamin K given depending on how soon the woman gave birth and the dosage given.  More recent studies have shown increases in cord blood levels where mothers were supplemented antenatally with vitamin K. Two showed a significant difference between the supplemented and unsupplemented groups and found that the effect of prenatal vitamin K persisted until the fifth day after birth.  
Because of the variations in results from these early studies, further research focused on treating the baby after birth.  One particular study done in 1942was intended to determine the minimal effective oral dose of Synkavite (K), a water-soluble synthetic form of vitamin K.  The results showed that very small daily doses were effective and that a dose of 5mg daily would probably prevent the development of HDN, except in early onset cases.  The study also found that 1.25mg was effective in lowering an excessively high prothrombin time to normal.  However, the author admitted that several workers found prothrombin deficiencies in babies with no abnormal bleeding.  
By 1950, most maternity units had a policy of giving infants oral vitamin K (usually Synkavite) immediately after birth. This prevented the fall in prothrombin levels that occurred in the first few days and, presumably, the risk of excessive bleeding.  This risk was higher in male babies because of routine circumcision, and, indeed, vitamin K proved to be of great clinical value in preventing post-circumcision bleeding. "
"According to the age of onset, early VKDB presents within 24 hours of birth and is almost exclusively seen in infants of mothers taking drugs [that] inhibit vitamin K. These drugs include anticonvulsants (carbamazepine, phenytoin and barbiturates), antituberculosis drugs (isoniazid, rifampicin), some antibiotics (cephalosporins) and vitamin K antagonists (coumarin, warfarin). The clinical presentation is often severe with cephalic haematoma and intracranial and intra-abdominal haemorrhages16. The incidence of early VKDB in neonates of mothers taking these drugs without vitamin K supplementation varies from 6% to 12%17,18.

Classical VKDB occurs between 24 hours and 7 days of life and is associated with delayed or insufficient feeding. The clinical presentation is often mild, with bruises, gastrointestinal blood loss or bleeding from the umbilicus and puncture sites. Blood loss can, however, be significant, and intracranial haemorrhage, although rare, has been described15. Estimates of the frequency vary from 0.25% to 1.5% in older reviews19 and 0–0.44% in more recent reviews20."
Has it been effective: as in, has the incidence decreased because of the intervention/procedure/test?
“Recent studies, using a standardized definition, seem to show that the condition is not now very common, even in communities where prophylaxis is not yet available. It is certainly not nearly as common as some authoritative reports claim. Two studies in Japan before the introduction of routine prophylaxis had suggested that one in every 6000 breastfed babies might sustain a late bleed when more than two weeks old. The true risk of bleeding in the first week of life (the “classic” presentation) remains less clearly defined.”
Source: E Hey. “Vitamin K – what, why and when.” Archives of Disease in Childhood Fetal and Neonatal Edition 2003; 88:F80.

  • VKDB is a rare but very serious disease. It affects about 1 in 10,000 babies if they are not given vitamin K at birth.  More than half of all babies who bleed have a hemorrhage into their brain (intracranial bleeding). This is likely to cause brain damage, and often the baby will die. [1]
  • Some babies appear to be at increased risk of VKDB and doctors believe these include [2]:
    • Babies born before 37 weeks of pregnancy.
    • Babies whose birth involved the use of forceps, [vacuum] or caesarean, where bruising might occur.
    • Babies who had trouble breathing and did not get enough oxygen when they were born.
    • Babies whose mothers are taking anticonvulsants, anti-coagulants, or drugs to treat tuberculosis.



  • The amount of vitamin K injected into newborns is 20,000 times the needed doseiv . Additionally, the injection may also contain preservatives that can be toxic for your baby’s delicate, young immune system. [1]
  • An injection creates an additional opportunity for infection in an environment that contains some of the most dangerous germs, at a time when your baby’s immune system is still immature. [1]
  • Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of Vitamin K1 Injection [2]
  • Injection contains preservatives and other ingredients.
  • Each milliliter contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive. [3]

Injection also includes following:
Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione, even when precautions have been taken to dilute the phytonadione and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving phytonadione for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.
Additional Information

Please make sure to check out the other topics in the Info Sheet series as you educate yourself and prepare to write your birth, postpartum and newborn plan for your family.

What are your thoughts on the Vitamin K shot?
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The material included on this site is for informational purposes only.
It is not intended nor implied to be a substitute for professional medical advice. The reader should always consult her or his healthcare provider to determine the appropriateness of the information for their own situation.  Krystyna and Bruss Bowman and Bowman House, LLC accept no liability for the content of this site, or for the consequences of any actions taken on the basis of the information provided.  This blog contains information about our classes available in Chandler, AZ and Payson, AZ and is not the official website of The Bradley Method®. The views contained on this blog do not necessarily reflect those of The Bradley Method® or the American Academy of Husband-Coached Childbirth®.