A new trial found that when compared to 0.3mg IM vitamin K birth prophylaxis, 1mg and 0.5 mg doses resulted in high sufficiency on follow-up. The trial results were published in 'The journal of Pediatrics.'
Intramuscular administration of vitamin K to prevent vitamin K deficiency bleeding (VKDB) has been a standard of care for a long time. Researchers conducted Open labeled, parallel-group, randomized clinical trial to study the efficacy of three different vitamin K birth prophylaxis regimens in premature infants at a Tertiary neonatal care unit in India.
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Eligible patients included very preterm infants born ≤ 32 weeks and very low birth weight infants born ≤1500g. Infants were randomized, and 25 babies were enrolled in each group to receive 1.0mg,0.5mg, or 0.3mg of vitamin K1 I.M. (intramuscular) at birth. Protein induced by vitamin K absence - II (PIVKA-II) levels were assessed on days 5 and 28 along with the frequency of death, bleeding manifestations, intraventricular hemorrhage, necrotizing enterocolitis, bilirubin levels, and duration of phototherapy. The primary outcome was a comparison of PIVKA-II levels on day 5 of life.
Results:
All the 3 regimens resulted in a similar proportion of vitamin K subclinical sufficiency (PIVKA-II < 0.028 AU/ml) infants on day 5[p 0.347], with no significant difference in median (interquartile range) PIVKA-II levels.
Vitamin K dosage proportion of babies
1 mg 100%
0.5mg 91.7%
0.3 mg 91.7%
However, on day 28, there was a significant fall in the proportion of vitamin K-sufficient infants in the 0.3mg IM group compared to the 1.0mg or 0.5mg groups.
Vitamin K dosage
proportion of babies
1 mg 100%
0.5 mg 91.3%
0.3 mg 72.7%
The 1.0mg group had significantly higher bilirubin levels and duration of phototherapy.
There were no statistically different clinical outcomes.
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Take-home points:
In a randomized controlled trial comparing prophylactic vitamin K doses in 75 very preterm or very low birth weight infants, those receiving 1 mg intramuscular vitamin K at birth had significantly lower rates of vitamin K deficiency at 28 days than those receiving 0.3 mg.
No significant difference was found in rates of specific bleeding complications or mortality based on prophylactic vitamin K dosage
Further reading: Hunnali CR, Devi U, Kitchanan S, S G. Three different regimens for vitamin K birth prophylaxis in preterm infants: A randomized clinical trial [published online ahead of print, 2022 Nov 4]. J Pediatr. 2022;S0022-3476(22)00992-1. doi: 10.1016/j.jpeds.2022.10.031