Abstract
Objective
This prospective study compared PIVKA-II and PT-INR levels in infants who received two vitamin K (VK) prophylactic regimens.
Methods
A single institution administered 119 healthy newborns 2 mg of VK syrup. Infants were assigned to a 3-time regimen (n = 56) with VK at birth, five days (5D), and 1-month-old (1 M), or a 13-time regimen (n = 63) with VK at birth, 5D, and then weekly for 11 weeks.
Results
The 13-time regimen significantly lowered PIVKA-II and reduced PT-INR at 1 M in both breastfed (PIVKA-II: 18–16 mAU/mL, p = 0.02; PT-INR: 1.37–1.13, p < 0.01) and formula-fed infants (PIVKA-II: 18–15 mAU/mL, p = 0.01; PT-INR: 1.54–1.24, p < 0.01), compared to baseline measurements taken at 5D. The 3-time regimen did not significantly alter PIVKA-II levels and only improved PT-INR (2.00–1.50, p < 0.01) in formula-fed infants.
Conclusion
The 13-time VK regimen significantly enhanced coagulation profiles more effectively than the 3-time regimen.
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Data availability
The datasets generated and analyzed during the current study are not publicly available due to institutional ethical policy.
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Acknowledgements
We sincerely thank Dr. Akira Shirahata (Kitakyushu Yahata Higashi Hospital) and Dr. Yukihiro Takahashi (Todaiji Ryoiku Hospital for Children) for their helpful advice on our study design and Miyuki Sakemoto MT and Kumiko Watanabe MT for the advice concerning technical procedures and guidance on sample measurements.
Funding
This work was supported by JSPS KAKENHI (JP22K07916 [Ochiai M]), AMED (JP20ek0109481 [Ohga S]), and the Japanese Society of Obstetrical, Gynecological and Neonatal Hematology.
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Takahashi D, Egami N, and Ochiai M conceptualized and designed the study, designed the data collection instruments, collected the data, carried out initial analyses, drafted the initial manuscript, and critically reviewed and revised the manuscript. Hotta T measured and analyzed the collected samples and critically reviewed and revised the manuscript. Suga S conducted the initial analyses and critically reviewed and revised the manuscript. Suga S, Ishimura M, Kawaguchi C, Uchiumi T, Nishikubo T, Nogami K, and Goto K conceptualized and designed the study and critically reviewed and revised the manuscript. Ohga S supervised the study design, drafted the initial manuscript, and critically reviewed and revised the manuscript. All authors had access to the data, approved the final manuscript as submitted, and agreed to be responsible for all aspects of this work.
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The study protocol was reviewed and approved by the Fukuda Hospital institutional review board (27-1-2). Written informed consent was obtained from each parent of candidate newborns.
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Takahashi, D., Egami, N., Ochiai, M. et al. Vitamin K prophylaxis in neonates: comparing two different oral regimens. J Perinatol (2024). https://doi.org/10.1038/s41372-024-01981-9
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DOI: https://doi.org/10.1038/s41372-024-01981-9