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Oral neonatal vitamin K deficiency bleeding prophylaxis in Switzerland (2018-2024), still valid guidelines for
Bernard Laubscher1,2,3, Gregor Schubiger4, Mattia Rizzi5,6,7
1Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland. bernard.laubscher@bluewin.ch.
Insights
Vitamin K prophylaxis in Switzerland remains effective for preventing vitamin K deficiency bleeding in healthy infants. Despite parental refusal concerns, the established guidelines continue to demonstrate efficacy in a nationwide study.
Area of Science:
- Neonatal Medicine
- Pediatric Hematology
- Public Health Policy
Background:
- Infantile vitamin K deficiency bleeding (VKDB) is preventable with intramuscular or oral vitamin K (VK).
- Parental refusal of VK prophylaxis and unrecognized cholestasis are key risk factors for VKDB.
- Switzerland's 2003 oral VK prophylaxis regimen is recommended for healthy infants.
Purpose of the Study:
- To prospectively evaluate the effectiveness of Switzerland's current oral vitamin K (VK) prophylaxis guidelines for preventing VKDB.
- To assess VKDB incidence in infants born between September 1, 2018, and August 31, 2024.
Main Methods:
- A nationwide surveillance program (Swiss Paediatric Surveillance Unit) was used to identify hospitalized VKDB cases.
- Data were collected over a 6-year period (2018-2024) for 505,708 live births.
- Incidence rates were calculated and compared to previous data.
Main Results:
- Nine cases of VKDB were reported, resulting in an incidence of 1.78 per 100,000 live births.
- All affected infants were exclusively breastfed and had risk factors like parental VK refusal or cholestasis.
- The VKDB incidence was similar to the 2005-2011 period.
Conclusions:
- Switzerland's VKDB prophylactic guidelines, implemented in 2003, remain valid and effective for healthy infants when followed.
- The study confirms the continued efficacy of the oral vitamin K regimen in preventing VKDB.
- Parental refusal and cholestasis remain significant risk factors necessitating vigilance.
Abstract:
Vitamin K (VK) deficiency is a condition that puts newborn infants at increased risk of vitamin K deficiency bleeding (VKDB) during the first 6 months of life. In Switzerland, current prophylactic guidelines have been shown to prevent VKDB effectively in healthy infants. They were implemented in 2003 and prescribe oral administration of VK (2 mg oral Konakion® MM (mixt micellar) hour 4, day 4, and week 4). As prophylaxis parental refusal has been increasingly reported, we prospectively tested the Swiss VKDB prophylaxis validity using a nationwide surveillance program (Swiss Paediatric Surveillance Unit) designed to detect all hospitalized VKDB cases. During 6 years (September 1, 2018, until August 31, 2024), nine VKDB cases were reported for 505,708 live births (1.78/105, 95% CI 0.81/105-3.38/105). All infants were exclusively breast fed and had VKDB risk factors such as parental VK refusal and/or cholestasis. Both Swiss VKDB 2018-2024 and 2005-2011 incidences were similar.
Conclusion:
The Swiss VKDB prophylactic guidelines are still valid and effective for healthy infants if applied appropriately.
What Is Known:
• Infantile vitamin K deficiency bleeding (VKDB) can be prevented by either intramuscular or oral VK administration in healthy infants. • Parental VK prophylaxis refusal (reported as increasing in frequency) as well as unrecognized cholestasis are main risk factors for VKDB.
What Is New:
• Switzerland's 2003 VKDB prophylactic regimen (2 mg oral Konakion® MM (hour 4, day 4, and week 4) remains a valid recommendation for healthy infants. • Again, parental VK prophylaxis refusal and/or unrecognized cholestasis remain risk factors for VKDB.
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