Indian Pediatr. 2025 Feb 15;62(2):116-120. doi: 10.1007/s13312-025-3374-6.
ABSTRACT
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.
PMID:39912270 | DOI:10.1007/s13312-025-3374-6
