Neonatal vitamin K prophylaxis in the British Isles: current practice and trendsBMJ 1995; 310 doi: https://doi.org/10.1136/bmj.310.6980.632 (Published 11 March 1995) Cite this as: BMJ 1995;310:632
- J S Barton, senior paediatric registrara,
- J H Tripp, senior lecturer in child healtha,
- A W McNinch, consultant paediatriciana
- Correspondence to: Dr J S Barton.
- Accepted 18 January 1995
In 1992 an unexpected association was reported between intramuscular vitamin K prophylaxis in the neonatal period and later childhood cancer.1 Although unconfirmed, the report obliged paediatricians to review their prophylaxis policies and led the British Paediatric Association to recommend the routine use of oral vitamin K in all healthy neonates, reserving intramuscular prophylaxis for those at greatest risk of vitamin K deficiency bleeding.2 We have documented changes in prophylaxis policies so that any consequences can be assessed in terms of either the incidence of vitamin K deficiency bleeding or any possible side effects.
Materials, methods, and results
In October 1993 a questionnaire was sent to every neonatal unit listed by the Neonatal Nurses' Association requesting information on annual delivery rate, details of vitamin K prophylaxis policy, and any policy changes since January 1992. Results were compared with those in a similar survey in 1988.3 Replies were received from 253 (98%) units, representing 747000 deliveries a year (90% of births in the British Isles). Trends in practice since 1970 include an increase in the proportion of babies given any prophylaxis (from 23% to 98%) and an increase in the proportion given vitamin K by mouth (from none to 58%). The proportion of babies routinely given intramuscular vitamin K increased from 23% in 1970 to 58% in 1982 and 1988, falling again to 38% in 1993 (table).
No consensus exists regarding the dose or frequency of administration of oral vitamin K, the total dose varying by a factor of 65. The commonest regimens recommend three doses of 0.5-1.0 mg over the first six weeks, but 37 neonatal units (15% of births) did not recommend any doses beyond 7 days of age, despite reports of late failure of single oral dose prophylaxis.4
Three quarters (73%) of the neonatal units surveyed had amended their vitamin K policy since January 1992, including 39 units which still recommended parenteral prophylaxis for all but offered oral prophylaxis if parental consent for injection was withheld. Reasons for a policy change included concern over possible adverse effects of intramuscular vitamin K (71%), reports of vitamin K deficiency bleeding (49%), and problems over the use of an unlicensed oral preparation (27%).
Almost all infants born in the British Isles now receive vitamin K prophylaxis and the trend towards oral administration continues. Neverthless, 27% of nurseries cited concern about the unlicensed oral use of vitamin K preparations as a reason for policy changes. Professionals may feel trapped by a dilemma. Giving vitamin K by intramuscular injection is seen as undesirable and may be associated with an increased risk of cancer, yet the injection uses a licensed preparation and provides reliable protection against vitamin K deficiency bleeding. Conversely oral regimens avoid the trauma of injection and any potential risk of extremely high blood concentrations and have not been implicated in any cancer risk. However, the efficacy of multiple oral dose regimens is not well established. They are complicated to administer, and their use of unlicensed preparations may theoretically expose professionals to litigation in the event of failure of prophylaxis or of unforeseen adverse effects.
The data highlight the current confusion over the optimal dose of oral vitamin K. Formula fed infants, whose vitamin K intake is around 25 μg daily, rarely bleed from vitamin K deficiency. Hence it would be logical to suppose that a similar daily supplement given to breast fed infants would also be protective while avoiding unphysiological peak plasma concentrations.2
Whatever regimen is used, we suggest that parents should be given written information about vitamin K prophylaxis and deficiency bleeding early in pregnancy to allow time for deliberation. The recommendations of the maternity unit can then be stated, including endorsement of breast feeding, and signed consent requested.