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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 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 • 7. References
History • 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 • 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 • 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
Common Clinical Manifestations • Bleeding in the • gastrointestinal tract • urinary tract • umbilical stump • nose • scalp • intracranial hemorrhage • Shock • death
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
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
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.
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 • Still not routine in Japan, Germany, UK • Routine prophylactic Vitamin K for newborns adopted in • Canada • Australia • New Zealand • Croatia, 1988
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
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 • 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 • 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.
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.