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Updated: May 29, 2025
Intravenous Injections in Neonatal Mice
Published on: November 11, 2014
One Milligram Versus Two Milligram Intramuscular Vitamin K to Prevent Late-Onset Hemorrhagic Disease in Young
Amala Srilatha Natarajan1, C G Delhikumar2, G P Senthil Kumar3
1Department of Pediatrics, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
Insights
A standard 1 mg dose of vitamin K1 (Phytomenadione) and a higher 2 mg dose showed similar efficacy in preventing subclinical vitamin K deficiency bleeding (VKDB) in neonates. Both intramuscular doses effectively reduced protein induced by vitamin K absence (PIVKA II) levels, indicating comparable protection against VKDB.
Area of Science:
- Neonatal Medicine
- Pediatric Hematology
- Pharmacology
Background:
- Vitamin K deficiency bleeding (VKDB) is a preventable condition in newborns.
- Subclinical VKDB, indicated by elevated protein induced by vitamin K absence (PIVKA II) levels, poses a risk for late-onset bleeding.
- Intramuscular vitamin K1 (Phytomenadione) is administered at birth to prevent VKDB.
Purpose of the Study:
- To compare the efficacy of a standard 1 mg dose versus a 2 mg dose of intramuscular vitamin K1 in reducing subclinical late-onset VKDB.
- To assess efficacy using serum PIVKA II levels as a biomarker for vitamin K status.
Main Methods:
- An open-labeled randomized controlled trial enrolled healthy term neonates.
- Participants received either 1 mg or 2 mg of vitamin K1 IM at birth.
- Serum PIVKA II levels were measured at birth, 30 days, and 72 days; subclinical VKDB was defined as PIVKA II >100 ng/mL.
Main Results:
- No significant difference in PIVKA II levels was observed between the 1 mg and 2 mg vitamin K1 groups at any time point.
- PIVKA II levels significantly decreased by 72 days in the 1 mg group compared to birth levels (P = 0.012).
- The reduction in PIVKA II levels in the 2 mg group was not statistically significant.
Conclusions:
- Both 1 mg and 2 mg doses of intramuscular vitamin K1 demonstrated similar efficacy in preventing subclinical VKDB.
- The findings suggest that the standard 1 mg dose is sufficient for preventing late-onset VKDB.
- There is no increased benefit in using a 2 mg dose over the standard 1 mg dose for this indication.
Objective:
To compare the efficacy of a standard dose (1 mg) with 2 mg vitamin K administered by intramuscular (IM) route in reducing subclinical late-onset vitamin K deficiency bleeding (VKDB) assessed using serum protein induced by vitamin K absence (PIVKA II) levels.
Methods:
This was an open-labeled randomized controlled trial that enrolled healthy term neonates delivered vaginally. Neonates delivered to mothers receiving antiepileptics, anti-tuberculous drugs, or warfarin, and those with a family history of bleeding disorder were excluded. Participants were randomized to receive either 1 or 2 mg of vitamin K1 (Phytomenadione) IM at birth. PIVKA II was measured in the cord blood and at 30 and 72 days after birth by ELISA method. PIVKA II level >100 ng/mL was labeled as subclinical VKDB.
Results:
Forty-one neonates were recruited in each arm. On the 30 days follow-up visit 9 infants (4 in 1 mg group; 5 in 2 mg group) were lost to follow-up. All babies had PIVKA II levels >100 ng/mL at birth. The median PIVKA II values (ng/mL) in the 1 mg group were 827.68 (cord blood), 678.80 (30 days), and 644.10 (72 days). The corresponding levels (ng/mL) in the 2 mg group were higher, viz., 770.55, 726.35, and 693.14 ng/mL; P > 0.05 for all comparisons. PIVKA II level in the 1 mg group reduced significantly on 72 days of life compared to that observed at birth (cord blood) (P = 0.012). However, the fall in 2 mg group was not statistically significant.
Conclusion:
There was no difference in PIVKA II levels between neonates receiving 1 mg or 2 mg vitamin K IM suggesting a similar risk for late-onset VKDB in both groups.
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