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Three Different Regimens for Vitamin K Birth Prophylaxis in Infants Born Preterm: A Randomized Clinical Trial

Charan Raj Hunnali1, Usha Devi2, Srinivasan Kitchanan3

  • 1Department of Pediatrics, KBN Faculty of Medical Sciences, Khaja Bandanawaz University, Kalaburagi, Karnataka.

The Journal of Pediatrics
|November 7, 2022
PubMed

Insights

Vitamin K prophylaxis in preterm infants showed that 1-mg and 0.5-mg doses maintained vitamin K sufficiency longer than the 0.3-mg dose. Current recommendations for vitamin K birth prophylaxis in preterm infants should continue.

Area of Science:

  • Neonatal Medicine
  • Pediatric Pharmacology
  • Biochemistry

Background:

  • Vitamin K prophylaxis is crucial for preventing hemorrhagic disease in newborns.
  • Preterm infants are at higher risk for vitamin K deficiency and related complications.
  • Optimal dosage of vitamin K1 for preterm infants remains an area of study.

Purpose of the Study:

  • To compare the efficacy of three different intramuscular (IM) vitamin K1 doses (1.0 mg, 0.5 mg, 0.3 mg) for prophylaxis in preterm infants.
  • To assess vitamin K sufficiency using Protein Induced by Vitamin K Absence-II (PIVKA-II) levels.
  • To evaluate clinical outcomes including bleeding, intraventricular hemorrhage, and mortality.

Main Methods:

  • An open-label, randomized clinical trial involving very preterm infants (≤32 weeks and/or ≤1500 g).
  • Infants were randomized to receive 1.0 mg, 0.5 mg, or 0.3 mg of IM vitamin K1 at birth.
  • PIVKA-II levels were measured at birth, day 5, and day 28, alongside clinical outcome monitoring.

Main Results:

  • All three vitamin K1 regimens achieved high subclinical vitamin K sufficiency on day 5.
  • On day 28, the 0.3-mg IM group showed a significant decrease in vitamin K sufficiency compared to 1.0-mg and 0.5-mg groups.
  • The 1.0-mg group experienced higher bilirubin levels and longer phototherapy duration; other clinical outcomes did not differ significantly.

Conclusions:

  • Both 1.0-mg and 0.5-mg IM vitamin K1 doses ensure sustained vitamin K sufficiency in preterm infants.
  • The current recommendation of 0.5-1 mg IM vitamin K1 for preterm infants is supported by these findings.
  • The 0.3-mg dose may be insufficient for long-term vitamin K sufficiency in this population.
Abstract

Keywords:
PIVKA IIneonatevitamin Kvitamin K deficiency bleeding

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