A new mixed micellar preparation for oral vitamin K prophylaxis: randomised controlled comparison with an intramuscular formulation in breast fed infants
a Department of Pediatrics, University of
Wisconsin, Madison, Wisconsin 53715, USA, b Department of Pediatrics, Franciscan-Skemp Medical
Center, La Crosse, Wisconsin 54601, USA, c The Haemophilia Centre, St Thomas's Hospital,
London SE1 7EH, UK, d Clinical
Pharmacology, Hoffmann-La Roche Inc, Nutley, New Jersey 07110, USA
Correspondence to: Dr F R Greer, Perinatal Center, 202 South Park Street, Madison, WI 53715, USA.
Accepted 7 April 1998
OBJECTIVE
To compare a new oral preparation of
vitamin K1 (Konakion MM) containing lecithin and
glycocholic acid with a standard intramuscular (IM) preparation during
the first 8 weeks of life in exclusively breast fed infants.
METHODSInfants were randomised at birth to the IM
group (1 mg vitamin K) or the oral group (2 mg given at birth and
repeated at 7 and 30 days of life). Prothrombin time (INR), plasma
vitamin K1, and PIVKA II (undercarboxylated prothrombin)
were monitored at 14, 30, and 56 days of age.
RESULTSSeventy nine infants were randomised to
the oral group and 77 to the IM group. Sixty seven infants in each
group completed eight weeks of the study. Prothrombin times did not
differ between the two groups. Mean (SD) plasma vitamin K1
values (in ng/ml) decreased in both groups over time, but were higher
in the oral group at 14 and 56 days: 2.0 (1.6) v 1.3 (1.1)
at 14 days; 0.5 (0.3) v 0.5 (0.7) at 30 days; and 0.5 (0.8) v 0.2 (0.2) at 56 days of life. PIVKA II was raised
(
0.1 AU/ml) in cord blood in 47% of the infants. By 14 days, only
one infant in each group had a raised PIVKA II value and both of these
initially had high concentrations of PIVKA II in cord blood. At 30 days, there were no raised PIVKA II values. At 56 days, there were no
raised PIVKA II values in the oral group, although three infants in the
IM group had raised values.
CONCLUSIONSPlasma vitamin K concentrations were
at least equal or significantly higher in babies given oral vitamin K
supplements compared with IM treated babies at the time points
measured. Through the first 8 weeks of life, multiple doses of the new
oral preparation maintain haemostasis and vitamin K status in breast
fed infants at least equal to that of the intramuscular preparation.
© 1998 by Archives of Disease in Childhood
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