Prophylactic Vitamin K Administration in Neonates on Prolonged Antibiotic Therapy: A Randomized Controlled Trial

ABSTRACT

Objective: To compare the prevalence of vitamin K deficiencyafter intramuscular vitamin K or no treatment in neonates withsepsis on prolonged (>7 days) antibiotic therapy.Study Design: Open label randomized controlled trial.Setting: Level 3 Neonatal Intensive Care Unit (NICU).Participants: Neonates with first episode of sepsison antibioticsfor ≥7 days were included. Neonates with clinical bleeding,vitamin K prior to start of antibiotic therapy (except the birth dose),cholestasis or prenatally diagnosed bleeding disorder wereexcluded.Intervention Randomized to receive 1 mg vitamin K (n=41) or novitamin K (n=39) on the 7th day of antibiotic therapy.Main outcome measure: Vitamin K deficiency defined as ProteinInduced by Vitamin K Absence (PIVKA-II) >2 ng/mL after 7 ± 2days of enrolment.Results: The prevalence of vitamin K deficiency was 100%(n=80) at enrolment and it remained 100% even after 7 ± 2 days ofenrolment in both the groups.Conclusion: Neonates receiving prolonged antibiotics haveuniversal biochemical vitamin K deficiency despite vitamin Kadministration on 7th day of antibiotic therapy.