In addition, oral vitamin K prophylaxis is considered incomplete if at least one oral dose but not all recommended doses are given according to age, or if an inadequate dose or preparation is given, although it is considered complete if all recommended doses are given at the time of bleeding. However, prophylactic failure has continued to occur in infants who were later proven to have cholestatic liver disease, although other main risk factors include parental refusal and accidental omission. In a nation-wide survey in 2005, the incidence of VKDB was determined to be 1.9 per 100,000 births. With the incorporation of these prophylaxis guidelines, the frequency of VKDB in Japan has significantly decreased. In 1988, to prevent this condition, a protocol of three oral doses of vitamin K, 2 mg each, was recommended for all full-term neonates these are given on the day of birth, upon discharge from the maternity hospital, and at 1 month of age. In Japan, a nation-wide survey in 1981, before vitamin K prophylaxis was recommended, revealed that 7.1 cases of VKDB occurred per 100,000 births. The incidence of VKDB in infants without prophylaxis has been reported to range from 4.4 to 10.5 per 100,000 live births in Asia and Europe. Neonatal vitamin K deficiency bleeding (VKDB) causes digestive tract bleeding in the early neonatal period and intracranial hemorrhage in early infancy. Our study is the first to establish a RI for INRs that were measured using the CoaguChek XS in healthy term neonates. The CoaguChek XS device is safe, fast, and convenient for performing INR assays in neonates. The INR was found to correlate with gestational age, birth weight, and hematocrit value. A significant difference in the INR was noted between male (median value, 1.10 RI, 0.90–1.30) and female (median value, 1.10 RI, 0.90–1.24) neonates (p = 0.049). A RI for INRs in 4-day-old neonates was established using the CoaguChek XS with a median value of 1.10 and a range of 0.90–1.30. The enrolled neonates were orally administered vitamin K 6-12 h after birth. The INRs determined by CoaguChek XS were measured in 4-day-old neonates. ![]() This study included 488 healthy term neonates born at a perinatal center between July 2012 and June 2013. The objectives of the present study were to determine the reference intervals (RIs) for international normalized ratio (INR) using the CoaguChek XS by capillary puncture in healthy term neonates, to evaluate factors that correlate with INR, and to evaluate the device by assessing its ease of use in clinical practice. Although the device is used in adults and children, studies have not been performed to evaluate its clinical utility in neonates, and the reference value is unknown in this population. ![]() CoaguChek XS is a portable device designed to monitor prothrombin time while only drawing a small volume of blood. However, venous access and the volume of blood required for such testing can be problematic. A coagulation screening test might be necessary to detect prophylactic failure or incomplete prophylaxis. Neonates routinely receive vitamin K to prevent vitamin K deficiency bleeding, which is associated with a high mortality rate and a high frequency of neurological sequelae.
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