Prevention of subclinical vitamin K deficiency based on PIVKA-II levels: oral versus intramuscular route
Bakhshi, S.; Deorari, A.K.; Roy, S.; Paul, V.K.; Singh, M.
Indian Pediatrics 33(12): 1040-1043
1996
ISSN/ISBN: 0019-6061 PMID: 9141807 Document Number: 459917
Exclusively breast fed, appropriate-for-date term infants with normal Apgar score and born at the All India Institute of Medical Sciences, New Delhi, India were enrolled in a 2-phase pilot study. Subjects in the phase I trial (n=35) received no vitamin K supplementation. Phase II (n=54) subjects were block randomized in 2 groups: group A (n=27) received vitamin K 1.0 mg (intramuscularly) and group B (n=25) received vitamin K 2.0 mg (orally), under supervision and within 4 h of birth. Four infants from phase I trial and 2 infants from phase II trial were later excluded. Blood samples from all infants were collected at 72+or-12 h of age for prothrombin time (PT) and proteins (of factor II) induced in vitamin K absence (PIVKA-II). Vitamin K deficiency was defined as PIVKA-II value >2 ng/ml (determined by ELISA) and prolonged PT was defined as >1.5 x control. All infants were kept under observation for 7 days after birth. Phase I infants had a mean birth weight of 2.8 kg and a gestation period of 38.5 weeks. Of the 31 infants that completed the phase I trial, levels of PIVKA-II and PT were increased in 25 (80.6%) and 15 infants (48.4%), respectively. No bleeding manifestations or pathological jaundice were noted. The mean birth weight and gestation period recorded in phase II groups A and B were comparable (2.8 kg, 38.7 weeks vs. 2.9 kg, 38.8 weeks, respectively). PIVKA-II levels were reduced in the majority of phase II babies; 85.2% and 84% of infants in group A and B, respectively, had undetectable levels of PIVKA-II. PT was normal in all at 3-4 days. There was no significant difference between groups. Two infants in group B developed pathological jaundice requiring phototherapy (not attributed to the use of vitamin K). It is concluded that oral water-soluble vitamin K can be safely given and is as effective as intramuscular vitamin K for correcting subclinical vitamin K deficiency in exclusively breast fed term neonates.