M. Cornelissen et al., PREVENTION OF VITAMIN-K DEFICIENCY BLEEDING - EFFICACY OF DIFFERENT MULTIPLE ORAL DOSE SCHEDULES OF VITAMIN-K, European journal of pediatrics, 156(2), 1997, pp. 126-130
There is consensus that late vitamin K deficiency bleeding (VKDB) shou
ld be prevented by vitamin K prophylaxis. One single dose of 1 mg vita
min K-1 is effective if given i.m. or s.c., but not if given orally. R
epeated oral doses might be as effective as the parenteral dose but th
e optimal dose regimen remains to be established. Different oral dose
schedules are presently used in different countries. In Australia, Ger
many, The Netherlands and Switzerland active surveillance data on late
VKDB were collected in a similar manner and failure rates compared. I
dentical case definitions were used. There were three basic strategies
for oral and one for parenteral vitamin K prophylaxis for healthy new
borns in the four countries: (1) daily supplementation of low dose vit
amin K (25 mu g) for breast-fed infants (The Netherlands); (2) 3 x 1 m
g orally [Australia (January 1993 - March 1994) and Germany (December
1992 December 1994)]; (3) 1 mg vitamin K i.m. (Australia since March 1
994); and (4) 2 x 2 mg vitamin K (new mixed micellar preparation) (Swi
tzerland). The respective failure rates per 100,000 live births (inclu
ding cases given all recommended doses and those given incomplete prop
hylaxis) were for strategy: (1) 0.2 (0-1.3) in The Netherlands; (2) 2.
3 (95% CI 1.6-3.4) in Germany and 2.5 (1.1-4.8) in Australia (oral pro
phylaxis); (3) Australia (i.m. prophylaxis) 0 (0-0.9); and (4) 3.6 (0.
7-10.6) in Switzerland. The failure rates for complete prophylaxis onl
y were: strategy (1) 0 (0-0.7) in The Netherlands; (2) 1.8 (1.1-2.8) i
n Germany and 1.5 (0.5-3.6) in Australia; (3) Australia (i.m.) 0 (0-0.
9); and (4) 1.2 (0-6.5) in Switzerland. Conclusions The Australian dat
a confirm that three oral doses of 1 mg vitamin K are less effective t
han i.m. vitamin K prophylaxis. A daily low oral dose of 25 mu g vitam
in K-1 following an initial oral dose of 1 mg after birth for exclusiv
ely breast-fed infants may be as effective as parenteral vitamin K pro
phylaxis. The effectiveness of the ''mixed-micellar'' preparation of v
itamin K-1 needs further study.