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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 Busfield1,
  2. Andrew McNinch1,
  3. John Tripp2
  1. 1
    Royal Devon and Exeter NHSF Trust, Barrack Road, Exeter, UK
  2. 2
    Peninsula Medical School, Exeter, UK
  1. Alison Busfield, Neonatal Unit, Wonford Hospital, Royal Devon & Exeter NHS Foundation Trust, Barrack Road, Exeter EX2 5DW, UK

Abstract

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

Design: Efficacy and effectiveness calculated using current practice details, data from Southern Ireland and two previous surveys, together with contemporaneous studies of vitamin K deficiency bleeding (VKDB).

Setting: Current survey: United Kingdom (Great Britain and Northern Ireland). Efficacy and effectiveness tables: United Kingdom and Southern Ireland.

Main outcome measures: Current VK prophylaxis following uncomplicated term deliveries. Relative risk of VKDB calculated for the VK actually received and for “intention to treat”.

Results: Questionnaire response rate 95% (n = 243), all recommending VK prophylaxis. No association between unit size and route of administration. For uncomplicated term deliveries, 60% recommended intramuscular (IM) prophylaxis, 24% oral and 16% offered both routes without bias. All units offering IM gave a single dose, mostly 1 mg Konakion Neonatal. Oral regimens showed more variation: two thirds gave 2 mg (range 0.5–2 mg), the number of doses ranged from 1 to 11 and many used preparations off-licence or the unlicensed Orakay. IM prophylaxis, if 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 intended IM VK and after oral prophylaxis intended to continue beyond a week.

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

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

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Footnotes

  • Competing interests: JHT and AWM have received funding from Roche Pharmaceuticals. JHT acted as an expert witness to the MHCA in an appeal for approval of an oral preparation of vitamin K1 by another company. Neither Roche nor the funders of this study have influenced the research or publication in any way.

  • Ethical approval was obtained from the North and East Devon Research Ethics Committee.

  • Abbreviations:
    IM
    intramuscular
    IV
    intravenous
    VK
    vitamin K
    VKDB
    vitamin K deficiency bleeding

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