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Vitamin K and Hemorrhagic Disease of the Newborn TH Tulchinsky MD MPH Braun School of Public Health, Hebrew University-Hadassah, Jerusalem Topics 1.    Disease 2.    Vitamin K 3.     Experience of the USA 4.     Experience of Israel 5.     Other countries 6. Summary of PH importance

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Vitamin k and hemorrhagic disease of the newborn l.jpg

Vitamin K and Hemorrhagic Disease of the Newborn

TH Tulchinsky MD MPH

Braun School of Public Health, Hebrew University-Hadassah, Jerusalem

Topics l.jpg

  • 1.    Disease

  • 2.    Vitamin K

  • 3.     Experience of the USA

  • 4.     Experience of Israel

  • 5.     Other countries

  • 6. Summary of PH importance

  • 7. References

History l.jpg

  • Townsend in Boston (1864) described 50 cases of “hemorrhagic disease of the newborn” during first 2 weeks of life

  • In 1929, Vitamin K isolated from alfalfa by Dam and Doisy (Nobel Prize, 1942), and conducted clinical trials showing Vitamin K protects against HDN

  • 1961, Am Acad Pediatrics and Am College Obstetrics and Gynecology recommended routine prophylaxis with Vit K for all newborns

  • Controversy in Britain in 1990s resolved to satisfaction of AAP, ACOG, Canada, Australia, New Zealand and others

Primary hdn l.jpg
Primary HDN

  • Often fatal condition

  • Diffuse hemorrhage in otherwise healthy infant

  • During the first week of life

  • Particularly in low birth weight babies

  • Results of low levels of prothrombin and other vitamin K dependent clotting factors, (Factors II, VII, IX and X) caused by vitamin K deficiency

  • An exaggerated of physiologic deficiency of clotting factors normal in the first few days of life

  • Incidence between 2.5 to 17.0 per thousand newborns not given vitamin K prophylactically

Late hdn l.jpg
Late HDN

  • Between 2-12 weeks of life,

  • Especially in breast-fed babies.

  • Immaturity of liver affects production of clotting factors

  • Late HDN primarily in breast fed infants without or inadequate vitamin K rates of 4.4-7.2/100,000 live births

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Common Clinical Manifestations

  • Bleeding in the

    • gastrointestinal tract

    • urinary tract

    • umbilical stump

    • nose

    • scalp

    • intracranial hemorrhage

    • Shock

    • death

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American Academy of Pediatrics 1961

  • Prophylactic use of Vit K recommended by the American Academy of Pediatrics, and by the American College of Obstetricians and Gynecologists since 1961.

  • Up until 1987, administration of vit K at birth was mandatory in only five states in the US

  • AAP recommendation renewed in 1993 and remains current

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New York State Review

  • We reviewed vital statistics in New York State finding infant deaths and hospitalizations attributed to neonatal hemorrhagic conditions (HDN)

  • Case record reviews showed absence of recorded giving of vitamin K in 65% of HDN deaths

  • Vit K was not included in standing orders in any of 22 NYS hospitals contacted

  • This review led to vit K being made a mandatory newborn care procedure in NY State Public Health Code in 1989

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Israel Experience

  • Vit K was widely used

  • However far from universal practice in the 1970s

  • In 1977, HDN deaths in Israel were 131/100,000 live births, declining to 31/100,000 live births in 1984 and 3/100,000 in 1988

  • In 1984, administration of vit K was made mandatory for newborn care by the Ministry of Health

  • A large decline in deaths from intracranial and intraventricular hemorrhage, may be partly due to routine use of vitamin K.

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Renewed Interest in Vit K

  • Since the 1980s attention – UK, Europe, Japan, Canada, Australasia and Middle East

  • HDN and vit K deficiency reported in both developed and developing countries where it is not routinely used, or where use may be waning

  • Controversy re oral versus parenteral use of routine Vit K largely resolved

  • Intramuscular administration within the first 6 hours after birth more effective in preventing both early and late HDN

Other countries l.jpg
Other Countries

  • Still not routine in Japan, Germany, UK

  • Routine prophylactic Vitamin K for newborns adopted in

    • Canada

    • Australia

    • New Zealand

    • Croatia, 1988

Public health importance l.jpg
Public Health Importance

  • Japanese incidence of HDN reported as 1/1,700 in breast fed babies and 1:4,500 in all infants

  • Of these, 82% were reported to have intracranial hemorrhage (ICH)

  • NDN still significant; even more in developing countries e.g. India, Thailand, Singapore and Taiwan

  • Thailand reports incidence of 35-72/100,000 births

  • ICH not always identified as HND related and may be significant factor in birth-related cerebral palsies

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Recommended Implementation

  • Mandatory within 6 hours of birth

  • Cost $1.00 including syringe per child

  • “Moderately cost-effective” (between $250-999 per DALY saved - estimates range from $52-533) – World Bank

  • Requires standing orders and Ministry of Health regulation

  • Professional initiative and support

Summary l.jpg

  • Deficiency of Vit K remains a significant worldwide cause of neonatal morbidity and mortality

  • Routine prophylactic use of vitamin K should always be used to prevent HDN (“good public health practice”)

  • Administration by intramuscular injection (0.5-1.0 mgm) within 6 hours of birth is preferable

  • May be given orally as 3 doses spread over the first 4 weeks of life

  • Vit K showing up in literature on osetoporosis

  • A safe, inexpensive preventive procedure that should be mandatory component of newborn care.

Bibliography l.jpg

  • American Academy of Pediatrics, Committee of Nutrition. Vitamin K compounds and the water-soluble analogues: use in therapy and prophylaxis in pediatrics. Pediatrics. 1961;28:501-506.

  • Motohara K et al. Severe vitamin K deficiency in breast-fed infants. J Paediatrics, 1984;105:943-945.

  • Lane PA, Hathaway WE. Vitamin K in infancy. J Pediatrics. 1985;106:351-359.

  • Caravella SJ et al. Health codes for newborn care. Pediatrics. 1987;80:1-5.

  • Shearer MJ. Vitamin K and vitamin K dependant proteins. Br J Hematology. 1990;75:156-162.

  • McNinch AW and Tripp JH. Haemorrhagic disease of the newborn in the British Isles: two year prospective study. BMJ, 1991;303:1105-1109.

  • American Academy of Pediatrics. Vitamin K Ad Hoc Task Force. Controversies concerning vitamin K and the newborn. Pediatrics. 1993;91:1001-1002.

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Bibliography, Continued

  • Tulchinsky TH, et al. Mandating vitamin K prophylaxis for newborns in New York State. Am J Public Health, 1993;83:1166-1168.

  • Von Kries R. Neonatal vitamin K: prophylaxis for all. BMJ. 1991;303:1083-1084.

  • Hanawa Y, Maki M, Murata B et al. The second nation-wide survey in Japan of vitamin K deficiency in infancy. European J Pediatr. 1988;147:472-477.

  • Visctora CG, Van Heake P. Vitamin K prophylaxis in less developed countries: policy issues and relevance to breast-feeding promotion. Am J Public Health, 1998;88:203-209.

  • Zipursky A. Prevention of vitamin K deficiency in newborns. Br J Haematology. 1999;104:430-437.