A NEW MIXED MICELLAR PREPARATION FOR ORAL VITAMIN-K PROPHYLAXIS - RANDOMIZED CONTROLLED COMPARISON WITH AN INTRAMUSCULAR FORMULATION IN BREAST-FED INFANTS

Objective-To compare a new oral preparation of vitamin K-1 (Konakion M M) containing lecithin and glycocholic acid with a standard intramuscu lar (IM) preparation during the first 8 weeks of life in exclusively b reast fed infants. Methods-Infants were randomised at birth to the IM group (1 mg vitamin K) or the oral group (2 mg given at birth and repe ated at 7 and 30 days of life). Prothrombin time (INR), plasma vitamin K-1, and PIVKA II (undercarboxylated prothrombin) were monitored at 1 4, 30, and 56 days of age. Results-Seventy nine infants were randomise d to the oral group and 77 to the IM group. Sixty seven infants in eac h group completed eight weeks of the study. Prothrombin times did not differ between the two groups. Mean (SD) plasma vitamin K-1 values (in ng/ml) decreased in both groups over time, but were higher in the ora l 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 (greater than or equal to 0.1 AU/ml) in cord bloo d 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 concentr ations of PIVKA II in cord blood. At 30 days, there were no raised PIV KA 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. Conclusions-Plasma vitamin K concentrations were at least equal or sig nificantly 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 h aemostasis and vitamin K status in breast fed infants at least equal t o that of the intramuscular preparation.