Vitamin K status in preterm infants: A randomised controlled trial to compare three regimes of prophylaxis

Clarke, P., Mitchell, S. J., Wynn, R., Sundaram, S., Sharma, V., Gardener, E., Kettle, R., Roeves, D. and Shearer, M. J. (2004) Vitamin K status in preterm infants: A randomised controlled trial to compare three regimes of prophylaxis. Pediatric Research, 56 (3). ISSN 0031-3998

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Background: Neonatal vitamin K stores are precarious. Without adequate vitamin K prophylaxis preterm infants may be at particular risk of vitamin K deficiency bleeding (VKDB), but the optimal dose and route is unclear. Objective: To compare the vitamin K status of preterm infants during the first week of life and when on full enteral feeds, following three regimes of vitamin K prophylaxis after delivery. Design/Methods: Infants born at < 32 weeks gestation were randomised to receive vitamin K1 0.5 mg intramuscularly (IM) (group 1: control), 0.2 mg IM (group 2) or 0.2 mg intravenously (IV) (group 3) on day 1. Cord blood was obtained; venous blood samples at 5 days postnatal and 2 weeks after establishment of full enteral feeds were analysed for serum vitamin K1, vitamin K1 2,3-epoxide, descarboxyprothrombin (PIVKA-II), and prothrombin time. Results: Of 98 infants enrolled, 90 had a day 5 sample and 80 had a second sample obtained at a median (IQR) of 25 (22–31) days. Baseline characteristics (mean ±SD) for groups 1 (n=31), 2 (n=34) and 3 (n=33) were respectively: gestational age 28.3 ±2.5, 28.6 ± 2.3, and 28.1 ±2.6 weeks; birthweight 1025 ±379, 1138 ±379, and 1060 ±371 g. Serum vitamin K concentrations (ng/mL) Compared with the control group, day 5 vitamin K concentrations were significantly lower in group 2 (p = 0.04), and at the time of established feeds they were lower in group 3 (p = 0.03). Three infants (one in group 2; two in group 3) had undetectable levels of vitamin K at the time of the second sample, however in each case PIVKA-II was undetected. Eleven of ninety (12%) infants (seven in group 1; four in group 3) had detectable concentrations of vitamin K epoxide on day 5 (p = 0.007). Conclusions: Preterm infants given 0.2 mg or 0.5 mg vitamin K1 at birth have very high serum concentrations during the first week of life. The presence of vitamin K epoxide is significantly associated with a higher dose (0.5 mg) of vitamin K given IM and with a reduced dose (0.2 mg) given IV, and may reflect vitamin K overload of the immature liver by these regimes of prophylaxis. With a reduced dose given IV or IM, vitamin K can fall to undetectable levels by as early as the fourth postnatal week. The risk of subsequent late VKDB may be increased in these infants unless further vitamin K supplements are given.

Item Type: Article
Uncontrolled Keywords: pediatrics, perinatology, and child health ,/dk/atira/pure/subjectarea/asjc/2700/2735
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Depositing User: LivePure Connector
Date Deposited: 16 Oct 2020 23:58
Last Modified: 30 Sep 2021 15:45
DOI: 10.1203/00006450-200409000-00077

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