A 1 mg dose of vitamin K given intramuscularly at birth prevents almost all
cases of late VKDB, whereas even two oral doses of 1 mg vitamin K given in
the first week and a third given in week 5 to 6 are less effective. Is eff
icacy improved by increasing the dose to 3 x 2 mg? For active surveillance
of VKDB, monthly postcards which include a nothing-to-report option, were s
ent to all heads of pediatric hospitals in Germany from January 1995 to Dec
ember 1998. All reports were validated according to a standard case definit
ion for late VKDB by means of a questionnaire. The incidence of VKDB with t
hree oral doses of 2 mg vitamin K is compared to previously published rates
for VKDB on 3 oral 1 mg oral doses, which had been ascertained with the sa
me surveillance scheme. The number of cases of VKDB (excluding the failure-
of-management cases) in children aged 8 days to 12 completed weeks during t
he 4 year period was 23. 14 had intracranial hemorrhage, 22 had been exclus
ively breastfed, and in 20 cholestasis was detected after the bleeding epis
ode. 14/23 had been given all recommended 2 mg doses for vitamin K prophyla
xis. Until 1996 all had been given the cremophor vitamin K preparation, whe
reas in 1997 to 1998 two children with late VKBD had received the new mixed
micellar (MM) preparation, first licensed in July 1996. The incidence of V
KBD per 100,000 live births during the 1995 to 1998 period was 0.72, includ
ing children given no vitamin K prophylaxis, and 0.44 for children who had
received all age-related recommended vitamin K doses.
These incidence rates are significantly lower than those previously publish
ed for the 3 x 1 mg dose regimen in Germany (1.8 cases of late VKDB per 100
,000 live births in children who had received all recommended vitamin K dos
es). Not all cases of late VKDB, however, are prevented by the 3 x 2 mg dos
e regimen, even if the new mixed micellar preparation is given instead of t
he cremophor preparation.