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Published on: September 20, 2019
A new mixed micellar preparation for oral vitamin K prophylaxis: randomised controlled comparison with an
F R Greer1, S P Marshall, R R Severson
1Department of Pediatrics, University of Wisconsin, Madison 53715, USA.
Insights
New oral vitamin K1 (Konakion MM) supplements effectively maintain infant vitamin K status and hemostasis, matching standard intramuscular injections. This oral preparation offers a comparable alternative for exclusively breastfed infants during the first eight weeks of life.
Area of Science:
- Neonatal Medicine
- Pediatric Nutrition
- Pharmacology
Background:
- Vitamin K deficiency bleeding (VKDB) is a risk in exclusively breastfed infants.
- Intramuscular (IM) vitamin K1 is the standard prophylactic treatment.
- New oral vitamin K1 preparations aim to improve infant vitamin K status.
Purpose of the Study:
- To compare a novel oral vitamin K1 preparation (Konakion MM) with standard IM vitamin K1.
- To evaluate vitamin K status and hemostasis in exclusively breastfed infants over 8 weeks.
- To assess the efficacy of oral vitamin K1 in preventing VKDB.
Main Methods:
- Randomized controlled trial comparing oral (2 mg multiple doses) and IM (1 mg single dose) vitamin K1.
- Monitored prothrombin time (INR), plasma vitamin K1, and PIVKA II levels at 14, 30, and 56 days.
- Included exclusively breastfed infants from birth to 8 weeks of age.
Main Results:
- No significant differences in prothrombin time (INR) between oral and IM groups.
- Plasma vitamin K1 levels were higher in the oral group at 14 and 56 days.
- PIVKA II levels normalized by 14 days in most infants; only three IM-treated infants had elevated levels at 56 days.
Conclusions:
- Oral vitamin K1 (Konakion MM) maintains hemostasis and vitamin K status comparable to IM administration.
- Multiple oral doses of vitamin K1 are effective for exclusively breastfed infants.
- This oral preparation presents a viable alternative for vitamin K prophylaxis in newborns.
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.
Methods:
Infants 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.
Results:
Seventy 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 (> or = 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.
Conclusions:
Plasma 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.
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