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Neonatal vitamin K prophylaxis in Great Britain and Ireland: the impact of perceived risk and product licensing on effectiveness.
  1. Alison Busfield (alison.busfield{at}rdehc-tr.swest.nhs.uk)
  1. Royal Devon & Exeter NHS Foundation Trust, United Kingdom
    1. Andrew William McNinch (andrew.mcninch{at}rdehc-tr.swest.nhs.uk)
    1. Royal Devon & Exeter NHS Foundation Trust, United Kingdom
      1. John H Tripp (jhtripp{at}ex.ac.uk)
      1. University of Exeter, United Kingdom

        Abstract

        Objective:To determine the current use of vitamin K (VK) prophylaxis in newborns and review the efficacy and effectiveness of regimens used.

        Design:Current practice details obtained by postal questionnaire and clarified by telephone/e-mail as necessary. Efficacy and effectiveness calculated from this, a similar survey in the Republic of Ireland, and from data of two previous surveys, each with a contemporaneous study of vitamin K deficiency bleeding (VKDB).

        Setting:Current survey: United Kingdom (Great Britain and Northern Ireland).

        Population included in efficacy and effectiveness tables: Great Britain, Northern Ireland and Republic of Ireland.

        Main outcome measures:Current VK prophylaxis given following term, uncomplicated deliveries. Relative risk, for all infants in the study area, of developing VKDB associated with different regimens calculated both for VK actually received and for 'intention to treat'.

        Results:Questionnaire response rate 95% (n=243), all recommending VK prophylaxis. There was no association between unit size and route of VK administration. For term uncomplicated deliveries, 60% recommended intramuscular (IM) prophylaxis, 24% oral, and 16% offered a choice of either route without a recommendation. All units offering IM prophylaxis gave a single dose, the majority 1mg Konakion Neonatal. Oral regimens showed more variation; two thirds gave 2mg (range 0.5-2mg), the number of doses ranged from 1 to 11 and many used preparations off-licence or the unlicensed Orakay. With the regimens used, IM prophylaxis, if actually given, provided the best protection (most efficacious) against VKDB. However, on an 'intention to treat' basis (effectiveness), there is no statistically significant difference between the risks of VKDB after planned IM VK and after oral prophylaxis planned to continue beyond a week.

        Conclusions:Although the principle of VK prophylaxis is now accepted by all there is no uniformity in administration. Omission of prophylaxis appears to be a greater problem for IM than for multi-dose oral prophylaxis, affecting coverage and overall effectiveness.

        • bleeding
        • infants
        • intracranial haemorrhage
        • prevention
        • vitamin-K-deficiency

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