A new mixed micellar preparation for oral vitamin K prophylaxis: randomised controlled comparison with an intramuscular formulation in breast fed infants

摘要

OBJECTIVE—To compare a new oral preparation ofvitamin K1 (Konakion MM) containing lecithin andglycocholic acid with a standard intramuscular (IM) preparation duringthe first 8 weeks of life in exclusively breast fed infants.
METHODS—Infants were randomised at birth to the IMgroup (1 mg vitamin K) or the oral group (2 mg given at birth andrepeated at 7and 30 days of life). Prothrombin time (INR), plasmavitamin K1, and PIVKA II (undercarboxylated prothrombin)were monitored at 14, 30, and 56 days of age.
RESULTS—Seventy nine infants were randomised tothe oral group and 77 to the IM group. Sixty seven infants in eachgroup completed eight weeks of the study. Prothrombin times did notdiffer between the two groups. Mean (SD) plasma vitamin K1values (in ng/ml) decreased in both groups over time, but were higherin 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 56days of life. PIVKA II was raised(⩾ 0.1 AU/ml) in cord blood in 47% of the infants. By 14 days, onlyone infant in each group had a raised PIVKA II value and both of theseinitially had high concentrations of PIVKA II in cord blood. At 30 days, there were no raised PIVKA II values. At 56 days, there were noraised PIVKA II values in the oral group, although three infants in theIM group had raised values.
CONCLUSIONS—Plasma vitamin K concentrations wereat least equal or significantly higher in babies given oral vitamin Ksupplements compared with IM treated babies at the time pointsmeasured. Through the first 8 weeks of life, multiple doses of the neworal preparation maintain haemostasis and vitamin K status in breastfed infants at least equal to that of the intramuscular preparation.