Newborns in New York State - NCBI

Mandating Vitamin K Prophylaxis for Newborns in New York State Theodore H. Tulchiksky, MD, MPH, Margaret M. Patton; MS, MSE4 RN, Linda A. Rando@h, MD, MPH, Monica R Meyer, MD, and Jeanne V

Lirdn, MD, MPH Intdudion

Hemorrhagic diseas of the newbom is a condition in which diffuse hemorrhag

re-

sults fom low levels of prormbin and other vitmin K-dependent cloting fact causedbyvitamin Kdeficiency. 12Low levels ofvitamin K, resulting in physioloc deficiency of clotting factors in the first few days of life, have been shown to occur in the cord blood of more than 20% of normal newboms. Approximately 25 to 5.0 newborns per 1000 not given prophylacic vitamin K develop clinically significant bleeding. Common clinical manifestations include intanial bleeding and bleding in the gastrointestinal tract, the umbilical stump, the scalp, and urinary traCt.3,4 Prophylactic use of vitamin K has been recommended for all newborns by the American Academy of Pediatrics since 1961, by the American College of Obstetricians and Gynecologists,"'5 and by major textbooks on neonatology, pediatrics, and hematology.6-10 Nevertheless, until 1987 administration of vitamin K at birth was mandatory in only five states within the United States.11 We reviewed the incidence of infant deaths and hospital discharges attnbuted to hemorrhagic disease of the newborn and other neonatal hemorrhagic conditions during the 1980s in New York State.

Methos The New York State Department of Health cafried out a search ofvital records of inant deaths for the period 1980 thrugh 1986. The review included only primary cause of death with the following Intemational ClaSifictn of Disease (IqCI9)12 codes: hemorrhagic disease of the newborn (ICD 776.0), disated intravascular coaulaton in the newborn (CD 776.2) and unspefied hematolocladisAderS specific to the fetus or newborn (ICD 776.9). Hospital records were reviewed for the infants whose deaths were attributed to these diagnoses. Each chart was reviewed by two graduate students in nursing to determine whether and when vitamin Kwas given and the nature and timing

of onset of bleeding. In cases where there was no documentation of vitamin K administration, the chart was reviewed with a senior consultant nurse. A second review of vital records for infant deaths that included primary and up to four secondary causes of death (avaiable for 1982 through 1988 only) from hemorrhagic diseas of the newborn and other hemorrhagic conditions ofthe newbom was carried out for the period 1981 though 1990. The dasewas searched for hemorrhagic diseaw of the newborn and disseminated intravascular coagulation. Because intraventicular hemorrhage (ICD 772. 1) has also been attnbuted to itamin K deficiency, the searchwas extended to indude intraventricular hemorrhage and subdural or cerebral hemonrhage (lCD 767.0).13 Hospital discharge information from the statewide system covering all hospitals providing matemity and newbom care in the state was analyzed for 1981 through 1990 for these diseases, again including primary and four secondary diagnoses.

Remd In 1987, vitamin K was not mentioned in standing orders in any of the 18 hospitals visited or in 4 others consulted, so that administration of vitamin K required a written medical order for each newbom. In the vital records review, 44 infant deaths due to hemorrhagic disease ofthe newborn and disseminated intravascular coagulation were identified throughout New York State.

Thedore H. Tulhisky is with the School of Public Health, State University of New York at Albany, and the Pvntive Health Services of the Ministy of Health in Jerusalem, Israel. At the time of the study, Margaret M. Patton was a conDepartsultant nurse with the New York State ment of Health, Albany, and Linda A. Randolph was with the Office of Public Health, New York State Deprtment of Health. Monica R. Meyer is with the Division of FamilyHealth and Jeanne V. Center for LaboLinden is with the Wadsworth ratories and Research, both at the New York State Departnent of Health, Albany.

Requests for reprints should be sent to Margaret M. Patton, MS, MSEd, RN, 91 Heritage Dr, Lake Wylie, SC 29710. This paper was accepted March 25, 1993.

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Hospital records were located and reviewed for 34 ofthese newborns. Ofthese, 6 (18%) had no documentation of receiving vitamin K at all, 16 (47%) received it after the onset of bleeding, and 12 (35%) received it before the clinical presentation of hemorrhage. The clinical and laboratory differentiation between hemorrhagic disease of the newborn and disseminated inhtavascular coagulation was not ahvays clear, and some records lacked confirmatory hematologic laboratory findings. Data from the second review included primary and four other causes of death and hospitalization, induding hemorrhagic disease of the newborn, disseminated intravascular coagulation in the newborn, intraventricular hemorrhage, and subdural or cerebral hemorrhage (Table 1). In thevital records review, multiple causes of death yielded many more cases than were found using primary diagnosis alone. During the period 1981 through 1990, there were 163 hospitalizations with a primary or secondary diagnosis of hemorrhagic diseas ofthe newbom alone, totaling 1286 days of care. Five ofthese hospitalized newborns had hemorrhagic disease of the newbom as the principal diagnosis, but 158 additional hospitalized newboms were found when the search included four secondary diagnoses.

Dission Vitamin K administration to new-

borns was thought to be standard practice in New York State during the 1980s. For the purpose of this review, and for medical and legal purposes, absence of documentation ofvitamin Kwasinterpretedtomean that vitamin Kwas not given. Ihis review showed hemorhagic that deaths and hospitalizationsfor hemorrhagic conditions related to vitamin K deficiency occurred in this period. In two thirds of the neonatal deaths reviewed, vitamin K was not documented as given or had been given after bleeding commenced. None of the 22 hospitals visited or consulted had standing orders for vitamin K administration. Vitamin K deficiency may contnbute to neonatal morbidity and mortality that is attributed to other diagnoses, such as disseminated intrvascular coagulation and intracanial hemorrhage. The pathophysiologic process of disseminated intravascular coagulation in the newborn may include deficiency of vitamin K),2 Intracranial hemorrhage is a known but not always considered manifestation of hemorrhagic disease of the newon.1-17 Both conditions commonly affect high-risk August 1993, Vol. 83, No. 8

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grOups such as prematu infants with respiatoty distress n e or sepsis. The diagnosis of di t intravascular coagulation in the newborn may not take the possIbiity of vitamin K deficiency into ac-

count ifthe diagn is made in the absence Of hematoogical data, as was the case in some of the charts reviewed. Although these deaths could not be attnbuted to lack of vitamin K, late use or nonuse of vtamin K in a bleeding neonate is of concem, partwclay if there are no confirmatory labordatly results. Lack of uniform policy for this procedure resulted in the injection's being given at various times followig birth, including after onset of bleeding, and in some cases not being given at all. Recent reports from various parts of the world, including the United Kingdom and Europe,18-2 Japan,25-29 the United States and Canada%133-34 Australasia,35and the Middle East,39indicate that hemorrhagic disease of the newborn is a problem where vitamin K is not routinely used and where its use may be waning. Because prematurity and breast-feeding are important risk factors for vhiamin K deficiency, this subject is also of importance in developing countries.25,40 Mandating preventive prctc in the care of newbons, as well as school immunization, is accepted in the United States. The mandate needs to be carried out. An initial review alerted the New York State Deprtmnt of Health to the fact that vitaminKwasnotbeing i droutinely. The departmnt then launched a full-scale chart review and anablsis. The results were formulated and presented as a policy paper to the New York State Pubic Health Council and the recommendations were approved. The New York State Health Conmmissoner then arranged an amendment to the state sanitaiy code to mandate vitamin

K prophylaxis witin 6 hours of birth. Administration of vtamin K to all newborns is an effective and avalable means of preventing at least appton of hemorrhagic neonatal deaths and shouldbe a mandatoiyprocedu in other parts of the United States and elsewhere. 0

Acknowlefgments

Death certificate and hospital chart reviews were carried out by Kathy Gannon, RN, and Lisa Robert, RN, graduate student nurse interns from Russell Sage College, Troy, NY. The vital records and hospitalization data were provided by Michael Zdeb of the Statistics Bureau, New York State Department of Health. We wish to acknowledge the encouragement and support of Dr David Axelrod, former Commissioner of Health, New York State Department of Health, and the advice and comments of Dr lloyd Novick, Center for Community Health; Dr Michael Cohen, Bureau of Child and Adolescent Health, New York State Department of Health; and Professor Eliezer

Rachmilevitz, Chief, HematologyDepartment, Hadassah Hospital, Ein Karem, Jerusalem.

References 1. Lane PA, Hathaway WE. Vitamin K in

infancy. JPediatr. 1985;106:351-359. 2. Shearer MJ. Vitamin K and vitamin K dependant proteins. BrJHaematoL 1990,75: 156-162. 3. Colman RW, Hirsh J, Marder VJ, Salmana EW. Hemostasis and Thrombosis: Basic Pnc4pes and Cical Pcce. Philadelphia, Pa: JB Lippincott Co; 1987:946-947. 4. American Academy of Pediatrics, Committee on Nutrition. Vitamin K compounds and the water-soluble analogues: use in therapy and prophylaxis in pediatrics. Pe-

diatijs. 1961;28:501-507.

5. American College of Gynecologists, Executive Board. Policy statement on Vitamin K administration. In: Mat7al and Fetal Medicine: Guidelines for Petnatal Care. Evanston, III: American College of Gynecologists; 1983. 6. Wintrobe MM, Lee GR, Boggs DR, et al. Clnical Hematlogy. 8th ed. Philadelphia, Pa: Lea & Febiger; 1981:1206-1226, 1981.

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Pubbc Health Briefs 7. Nathan D, Oski F, eds. Hematology ofInfancy and Childhood. Philadelphia, Pa: WB Saunders Co; 1974:582-583. 8. Nelson WE, Behrman RE, Vaughan VC. Tetbook of Peditics. 13th ed. Philadelphia, Pa WB Saunders Co; 1987:1069-1070. 9. Williams WJ, Beutler E, Erslev AJ, Lichtman MA. Hematology. 4th ed. New York, NY: McGraw-Hill Inc; 1990:1510-1513. 10. Thorup OK Fudamentals of Clinical Hematology. 5th ed. Philadelphia, Pa: WB Saunders Co; 1987:846-854. 11. Caravelia S, Clark D, Dweck H. Health codes for newbon care. Pediatics. 1987;80: 1-5. 12. International Classification of Diseases. 9th revision. Geneva, Switzerland: World Health Organization; 1977. 13. Buchanan GR. Coagulation disorders in the neonate. PediatrClin NorthAm. 1986; 33:203-220. 14. Khm y KS, Kuban KCK, Leviton A, Brown ER, Sullivan KF, Alfred EN.

Pervenfticlar-interventricu hemorrhage, sonographic lcalization, phenobarbital and motor abnomalities in low birth weight inPediatrics. 1990,85:1027-1033. fants. 15. Pape KE. Etiology and pathogenesis of intraventricular hemorrhage in newborns. Pediatrics. 1989;84:382-385. 16. MoralesWJ, AngelJL, O'BrienWF, Knuppel RA, Marsalisi F. The use of antenatal vitamin K in the prevention of early neonatal intraventricular hemorrhage. Am J Obstet GynecoL 1988;159:774-779. 17. Cbaou W, Chou M, Eitman D. Intaanial hemorrhage and vitamin K deficiency in early infancy. JPedatr. 1984;105:8804884. 18. McNinch AD, Orme RLE, Tripp JH. Hemorrhagic disease of the newborn returns. Lancet. 1983;1:1089-1090. 19. McNinch AW, Upton C, Samuels M, et al.

Plasma concentrations after oral and intramuscularvitamin Kl in neonates.ArchDis Chid 1985;60:814-818. 20. Von Kries R, Gobel U. Vitamin Kprophylaxis: oral or parenteral. Am J Dis Chil 1988;142:14-15. 21. Von Kries R. Neonatal vitamin K.- prophylaxis for all. BMT. 1991;303:1083-1084. 22. McNinch AW, Tripp JH. Haemorrhagic disease of the newborn in the British Isles: two year prospective study. BMJ. 1991; 303:1105-1109. 23. HandelJ, TrippJH. Vitamin Kprophylaxis against haemorrhagic disease of the newborn in the United Kingdom. BMJ. 1991; 303:1109. 24. Wefring K. Hemorrhage in the newborn and vitamin K prophylaxis. J Pediatr. 1962;61:686-692. 25. Motohara K, Matsukura M, Matsuda I, et al. Severe vitamin K deficiency in breastfed infants.JPediatr. 1984;105:943-945. 26. Motohara K, Endo F, Matsuda I. Effect of vitamin K administration on acarboxy prothrombin (PIVKA-II) levels in newborns. Lancet. 1985;2:242-244. 27. Hanawa Y, Maki M, Murata B, et al. The second nation-wide survey in Japan of vitamin K deficiency in infancy. EurJPediatr. 1988;147:472-477. 28. ShinzawaT, MuraT, Tsunei M, Shiraki K. Vitamin K absorption capacity and its association with vitamin K deficiency. Am J Dis Chid 1989;143:686-689. 29. Motohara K, Matsukane I, Endo F, Kiyota Y, MatsudaI. Relaonshipofmflkintake and vitamin K supplementation to vitamin K status in newbors. Pedatics. 1989;84:90-93. 30. Corrigan JJ, Kryc JJ. Factor II (prothrombin) levels in cord blood: correlation of coagulant activity with immunogenic protein. JPediatr. 1980;97:979-983.

31. O'ConnorM,AddiegoJ. Use of oralvitamin K to prevent hemorrhagic disease of the newborninfant. JPedatr. 1986;108:616-619. 32. Shapiro AD, Jacobson IJ, Armon ME, et al. Vitamin K deficiency in the newborn infant: prevalence and perinatal risk factors. JPediatr. 1986;109:675-680. 33. Behrmann BA, Chan WK, Finer NN. Resurgence of hemorrhagic disease of the newborn: a report of three cases. Can Med AssocJ. 1985;133:884-85. 34. Newbom Committee of the Canadian Pediatric Society. Guidelines for the use of vitamin K to prevent hemorrhagic disease of the newborn. Can Med Assoc J. 1988; 139:127-130. 35. Heron P, Cull A, Bouchier D, Lees H. Avoidable hazard to New Zealand children: case reports of hemorrhagic disease of the newborn. NZMedJ. 1988;101:507-508. 36. Birbeck JA. Vitanmin K prophylaxis in the newborn: a position statement of the Nutrition Committee of the Pediatric Society of NewZeaIand.NZMedJ. 1988;101:421-422. 37. Brown SG, McHugh G, Shapelski J, et al. Should intramuscular vitamin K prophylaxis for hemorrhagic disease of the newbom be continued? A decision analysis. N ZMedJ. 1989;102:3-5. 38. Clarkson PM, James AG. Parenteral vitamin K: the effective prophylaxis against hemorrhagic disease for all newborn infants. N Z Med J. 1990;103:95-96. 39. Alpan G, Avital A, Peleg O, Dgani Y. Late presentation of hemorrhagic disease of the newborn. Arh Dis Child 1984;59:482-483. 40. Canfield LM, Hopkinson JM, Lima AF, Silva B, Garza C. Vitamin K in colostrum and mature human milk over the lactation period-a cross-sectional study.AmJClin Nutr. 1991;53:730-735.

Fatal Car Fires from Rear-End Crashes: The Effects of Fuel Tank Placement before and after Regulation Leon S. Robertson, PhD

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In a rear-end crash, the fuel tank of a car, if located in the usual crush zone, may be ruptured at moderate speed if it is penetrated by other vehicle components. In 1973, the Insurance Institute for Highway Safety examined the integrity of fuel systems in six 1973-model cars by conducting front-to-rear crash tests at speeds of 36 to 40 miles per hour with the struck car sitting still. Fuel leaked from the tank of the struck car in eveiy case, and a spontaneous fire occurred in one test. Slow motion

film of the latter crash indicated that the fire enveloped the passenger compartment of the struck car before the vehicles came to rest but after the momentum of the crash was dissipated.' The author is with Nanlee Research, Branford, Conn, and the Department of Epidemiology and Public Health, Yale University, New Haven, Conn. Requests for reprints should be sent to Leon S. Robertson, PhD, Nanlee Research, 2 Montgomery Pkwy, Branford, CT 06405. This paperwas accepted January 25, 1993.

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