Abstract
Objective: To determine whether the use of mixed micellar vitamin K improves the efficacy of the 3 x 2 mg oral vitamin K prophylaxis schedule.
Design: Nationwide active surveillance for vitamin K deficiency bleeding (VKDB) complemented with two surveys on the use of the mixed micellar preparation in hospitals and by paediatricians.
Setting and patients: Infants in Germany in 1997–2000.
Intervention: Prophylaxis with three oral doses of 2 mg mixed micellar vitamin K.
Main outcome measure: Confirmed VKDB between day 8 and week 12 and no condition requiring specific vitamin K supplementation known before the onset of bleeding.
Results: Twenty nine reports met the case definition: seven had not received any vitamin K prophylaxis; for three, vitamin K prophylaxis was unknown; two had insufficient vitamin K prophylaxis for their age; 17 had been given the recommended doses. The mixed micellar preparation had been given to seven, other preparations to nine, and one had been given both. These cases did not differ with respect to the site of bleeding and cholestasis detected at bleeding. Estimates of the use of the mixed micellar preparation in birth hospitals and by paediatricians yielded 1 817 769 newborns exposed to the mixed micellar preparation and 1 320 926 newborns exposed to other preparations. The rate of late VKDB was 0.44/100 000 (95% confidence interval (CI) 0.19 to 0.87) in children given mixed micellar vitamin K compared with 0.76/100 000 (95% CI 0.36 to 1.39 ) in children given other preparations.
Conclusion: Mixed micellar vitamin K did not significantly improve the efficacy of the 3 x 2 mg oral vitamin K prophylaxis schedule.
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Selected References
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- Amédée-Manesme O., Lambert W. E., Alagille D., De Leenheer A. P. Pharmacokinetics and safety of a new solution of vitamin K1(20) in children with cholestasis. J Pediatr Gastroenterol Nutr. 1992 Feb;14(2):160–165. doi: 10.1097/00005176-199202000-00007. [DOI] [PubMed] [Google Scholar]
- Cornelissen M., von Kries R., Loughnan P., Schubiger G. Prevention of vitamin K deficiency bleeding: efficacy of different multiple oral dose schedules of vitamin K. Eur J Pediatr. 1997 Feb;156(2):126–130. doi: 10.1007/s004310050570. [DOI] [PubMed] [Google Scholar]
- Golding J., Greenwood R., Birmingham K., Mott M. Childhood cancer, intramuscular vitamin K, and pethidine given during labour. BMJ. 1992 Aug 8;305(6849):341–346. doi: 10.1136/bmj.305.6849.341. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Greer F. R., Marshall S. P., Severson R. R., Smith D. A., Shearer M. J., Pace D. G., Joubert P. H. A new mixed micellar preparation for oral vitamin K prophylaxis: randomised controlled comparison with an intramuscular formulation in breast fed infants. Arch Dis Child. 1998 Oct;79(4):300–305. doi: 10.1136/adc.79.4.300. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Hansen K. N., Ebbesen F. Neonatal vitamin K prophylaxis in Denmark: three years' experience with oral administration during the first three months of life compared with one oral administration at birth. Acta Paediatr. 1996 Oct;85(10):1137–1139. doi: 10.1111/j.1651-2227.1996.tb18216.x. [DOI] [PubMed] [Google Scholar]
- Hey E. Prevention of vitamin K deficiency in newborns. Br J Haematol. 1999 Jul;106(1):255–256. doi: 10.1046/j.1365-2141.1999.1577a.x. [DOI] [PubMed] [Google Scholar]
- Schubiger G., Stocker C., Bänziger O., Laubscher B., Zimmermann H. Oral vitamin K1 prophylaxis for newborns with a new mixed-micellar preparation of phylloquinone: 3 years experience in Switzerland. Eur J Pediatr. 1999 Jul;158(7):599–602. doi: 10.1007/s004310051155. [DOI] [PubMed] [Google Scholar]
- Wariyar U., Hilton S., Pagan J., Tin W., Hey E. Six years' experience of prophylactic oral vitamin K. Arch Dis Child Fetal Neonatal Ed. 2000 Jan;82(1):F64–F68. doi: 10.1136/fn.82.1.F64. [DOI] [PMC free article] [PubMed] [Google Scholar]
- von Kries R., Hachmeister A., Göbel U. Repeated oral vitamin K prophylaxis in West Germany: acceptance and efficacy. BMJ. 1995 Apr 29;310(6987):1097–1098. doi: 10.1136/bmj.310.6987.1097. [DOI] [PMC free article] [PubMed] [Google Scholar]
- von Kries R., Hanawa Y. Neonatal vitamin K prophylaxis. Report of Scientific and Standardization Subcommittee on Perinatal Haemostasis. Thromb Haemost. 1993 Mar 1;69(3):293–295. [PubMed] [Google Scholar]
- von Kries R. Neonatal vitamin K prophylaxis: the Gordian knot still awaits untying. BMJ. 1998 Jan 17;316(7126):161–162. doi: 10.1136/bmj.316.7126.161. [DOI] [PMC free article] [PubMed] [Google Scholar]