A 4-day-old full-term female came to clinic for her health supervision visit.
She was breastfeeding well for a total of 15-25 minutes every 2.5 – 3.0 hours with multiple bowel movements and urinations per day. Her parents were concerned because she was slightly jaundiced. She was sleeping well and was usually easily arousable. The past medical history showed a full-term normal spontaneous vaginal delivery after an 18 hour labor and delivery. Apgars were 8 and 9. She went home after 48 hours and had had regular newborn care with the exception of the parents refusing Vitamin K injection. Documentation revealed several conversations about this with the family and she had received a dose of oral Vitamin K in the first 24 hours of life, with the plan to repeat the dose at 5-7 days and again at 4 weeks.
The family history was non-contributory and was negative for bleeding problems and hepatobiliary problems. The review of systems was negative. The pertinent physical exam showed a quietly alert female with mild jaundice of the face and normal vital signs. Her weight was 3345 grams which was decreased from 3360 grams at discharge and decreased from a birth weight of 3390 grams. She had mild icterus of her skin and had no bruising. The rest of her examination was normal.
The diagnosis of a healthy newborn with very mild jaundice was made. As the family was leaving, the parents asked the physician for a prescription for more Vitamin K as they said they had not received a prescription. The physician wrote a prescription and had thought that it would be filled at the hospital pharmacy since they had compounded the medication previously. An outside pharmacy called the physician stating that there was no oral form of Vitamin K currently available, only an intravenous or injectable form. The physician asked the outside pharmacy to have the family return to the hospital pharmacy who was able to compound the Vitamin K into a suspension using a Vitamin K tablet.
Vitamin K is critical for prevention of Vitamin K Deficiency Bleeding (VKDB) formerly known as hemorrhagic disease of the newborn. Dr. Charles Townsend first described this entity in 1894. Vitamin K is necessary for the synthesis of prothrombin and Factors VII, IX and X. Vitamin K stores are low at birth and also are low in breast milk.
VKDB has 3 presentation variants:
- Bleeding occurs in first 24 hours.
- Bleeding sites – intraabdominal, intracranial, intrathoracic, skin and subperiosteal
- Generally occurs with mothers who are taking anticonvulsants, warfarin or anti-tuberculosis medications
- Bleeding occurs usually between day of life 1-7 days (especially at 2-5 days)
- Bleeding sites – circumcision, gastrointestinal, intraabdominal, intracranial, intrathoracic, and skin
- Incidence is 4.4-89 / 100,000 births without Vitamin K prophylaxis
- Bleeding occurs usually between 2-12 weeks (peak 3-8 weeks)
- Bleeding sites – intracranial, skin and gastrointestinal tract (up to 50% is intracranial)
- Occurs often in breastfed babies without Vitamin K prophylaxis
- Occurs in babies with unsuspected cholestatic liver disease who may have received Vitamin K. Bleeding may be the first indication of the problem
- Incidence is 4.4-72 / 10,000 births without Vitamin K prophylaxis
Vitamin K given close to birth helps to prevent all 3 variants. Vitamin K given IM generally prevents classical and late disease. Vitamin K given orally prevents classical but may not prevent late disease particularly if the baby is premature, breastfed or has liver disease. Internationally, there are different dosing regimens used, but basically babies with these risk factors need higher doses or more doses of Vitamin K.
In the United States currently there is only an intravenous/intramuscular/subcutaneous form of Vitamin K available. It is recommended by the American Academy of Pediatrics as it is the only one available and also because it treats both classical and late disease. In the future, it appears that an oral product will be licensed in the United States. Currently if an oral product is needed because of parental refusal of injectable Vitamin K, it must be compounded using a Vitamin K tablet. The tablet/compounded form is not as effective as the oral forms available in other counties as they are slightly different formulations. Also, as this tablet/compounded product is a suspension, there is also the additional problem that the Vitamin K may not actually be delivered as the suspended particles may fall to the bottom of the bottle, or stick to the sides of the bottle or syringe.
Questions for Further Discussion
1. Where can you get tablet/compounded Vitamin K in your community?
2. If you were on the expert panel for the American Academy of Pediatrics and the oral form of Vitamin K became available, what dosing regimen would you advocate for?
- Specialty: General Pediatrics | Hematology | Neonatology | Nutrition / Dietetics | Pharmacology / Toxicology
- Age: Newborn
To Learn More
To view pediatric review articles on this topic from the past year check PubMed.
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American Academy of Pediatrics Policy Statement. Controversies Concerning Vitamin K and the Newborn. Pediatrics. 2003:112;191-192. Available from the Internet at: http://aappolicy.aappublications.org/cgi/content/full/pediatrics;112/1/191 (rev. 09/2006 cited 7/16/09).
Auckland District Health Board. Newborn Services Clinical Guideline. Vitamin K prophylaxis and Vitamin K Deficiency Bleeding. Available from the Internet at: http://www.adhb.govt.nz/newborn/Guidelines/Blood/VitaminK.htm (rev. 7/16/09, cited 7/16/09).
Shearer MJ. Vitamin K deficiency bleeding (VKDB) in early infancy. Blood Rev. 2009 Mar;23(2):49-59. Epub 2008 Sep 19.
ACGME Competencies Highlighted by Case
1. When interacting with patients and their families, the health care professional communicates effectively and demonstrates caring and respectful behaviors.
2. Essential and accurate information about the patients’ is gathered.
3. Informed decisions about diagnostic and therapeutic interventions based on patient information and preferences, up-to-date scientific evidence, and clinical judgment is made.
4. Patient management plans are developed and carried out.
8. Health care services aimed at preventing health problems or maintaining health are provided.
9. Patient-focused care is provided by working with health care professionals, including those from other disciplines.
10. An investigatory and analytic thinking approach to the clinical situation is demonstrated.
11. Basic and clinically supportive sciences appropriate to their discipline are known and applied.
13. Information about other populations of patients, especially the larger population from which this patient is drawn, is obtained and used.
19. The health professional works effectively with others as a member or leader of a health care team or other professional group.
22. Sensitivity and responsiveness to patients’ culture, age, gender, and disabilities are demonstrated.
26. Partnering with health care managers and health care providers to assess, coordinate, and improve health care and how these activities can affect system performance are known.
Donna M. D’Alessandro, MD
Professor of Pediatrics, University of Iowa Children’s Hospital