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Oral mixed micellar vitamin K for prevention of late vitamin K deficiency bleeding
R von Kries1, A Hachmeister, U Göbel
1Institute for Social Paediatrics and Adolescent Medicine, Ludwig-Maximilians-University, Munich, Germany.
Insights
Mixed micellar vitamin K did not significantly improve oral vitamin K prophylaxis efficacy for preventing late vitamin K deficiency bleeding in infants. The study found similar rates of bleeding regardless of vitamin K preparation used.
Area of Science:
- Pediatric Hematology
- Neonatal Nutrition
- Pharmacology
Background:
- Vitamin K deficiency bleeding (VKDB) remains a concern in infants.
- Standard oral vitamin K prophylaxis schedules aim to prevent VKDB.
- The efficacy of different vitamin K preparations is crucial for optimal prophylaxis.
Purpose of the Study:
- To evaluate if mixed micellar vitamin K enhances the effectiveness of the standard 3 x 2 mg oral vitamin K prophylaxis regimen.
- To compare the incidence of late VKDB between infants receiving mixed micellar vitamin K and those receiving other oral preparations.
Main Methods:
- Nationwide active surveillance for VKDB cases in German infants (1997-2000).
- Surveys assessing the use of mixed micellar vitamin K preparations in hospitals and by pediatricians.
- Calculation of late VKDB incidence rates based on prophylaxis type.
Main Results:
- Out of 29 confirmed VKDB cases, 17 had received the recommended oral vitamin K doses.
- The incidence of late VKDB was 0.44/100,000 in infants given mixed micellar vitamin K versus 0.76/100,000 for other preparations.
- No significant difference in bleeding site or cholestasis was observed between groups.
Conclusions:
- The mixed micellar formulation of vitamin K did not demonstrate a significant improvement in preventing late VKDB compared to other oral preparations within the 3 x 2 mg schedule.
- Current oral vitamin K prophylaxis schedules require further investigation for optimal efficacy.
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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