Scholarlink

Objectives <p>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.</p> Methods <p>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 &gt;100 ng/mL was labeled as subclinical VKDB.</p> Results <p>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 &gt;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, <i>viz.</i>, 770.55, 726.35, and 693.14 ng/mL; <i>P</i> &gt; 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) (<i>P</i> = 0.012). However, the fall in 2 mg group was not statistically significant.</p> Conclusion <p>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.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

One Milligram Versus Two Milligram Intramuscular Vitamin K to Prevent Late-Onset Hemorrhagic Disease in Young Infants: A Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2025年1月30日

查看全文
  • Amala Srilatha Natarajan,
  • C. G. Delhikumar,
  • G. P. Senthil Kumar,
  • Nivedita Mondal,
  • R. Sasirekha

摘要

Objectives

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.