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Vitamin K to neonates. Peroral versus intramuscular administration
F S Jørgensen1, P Felding, S Vinther
1Department of Gynecology and Obstetrics, Rigshospitalet, University of Copenhagen, Denmark.
Insights
Oral vitamin K is as effective as an injection for preventing newborn bleeding. This study found no significant differences in coagulation factors or bleeding events between the two vitamin K administration methods.
Area of Science:
- Neonatal Medicine
- Pediatric Hematology
- Pharmacology
Background:
- Hemorrhagic disease of the newborn (HDN) is a serious condition.
- Vitamin K prophylaxis at birth is standard practice to prevent HDN.
- The optimal route of vitamin K administration is debated.
Purpose of the Study:
- To compare the efficacy of oral versus intramuscular vitamin K in preventing HDN.
- To evaluate biochemical markers of coagulation in newborns receiving different vitamin K formulations.
Main Methods:
- A randomized study involving 300 infants.
- Comparison of 1 mg peroral vitamin K versus 1 mg intramuscular vitamin K at birth.
- Measurement of coagulation factors II, VII, and X activity, prothrombin antigen, and PIVKA II.
- Observation for bleeding events until hospital discharge.
Main Results:
- No significant differences were observed in any biochemical markers between the oral and intramuscular vitamin K groups.
- Narrow 95% confidence intervals for all measured coagulation factors.
- Zero cases of bleeding were reported in either group.
Conclusions:
- Peroral administration of 1 mg vitamin K is as effective as intramuscular injection for preventing classical HDN.
- Oral vitamin K is a viable and safe alternative for neonatal prophylaxis.
Abstract:
In a randomized study of 300 infants, the effect of 1 mg of peroral vitamin K given at birth was compared to the same dose given as an intramuscular injection. The combined activity of coagulation factor II + VII + X taken after 48 and before 72 hours after delivery served as the primary endpoint. Prothrombin (antigen) and PIVKA II (acarboxyprothrombin) were also measured. All infants were observed for events of bleeding until discharge from the hospital, normally on the fifth day. No significant differences between the groups in any of the biochemical markers were observed. The 95% confidence limits of the differences were very narrow for all factors. No cases of bleeding were observed. We conclude that administration of 1 mg peroral vitamin K is as efficient as intramuscular administration of the same dose in the prevention of classical hemorrhagic disease of the newborn.