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

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Abstract

Objective

To compare the prevalence of vitamin K deficiency after intramuscular vitamin K or no treatment in neonates with sepsis 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 sepsis on antibiotics for ≥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 were excluded.

Intervention

Randomized to receive 1 mg vitamin K (n=41) or no vitamin K (n=39) on the 7th day of antibiotic therapy.

Main outcome measure

Vitamin K deficiency defined as Protein Induced by Vitamin K Absence (PIVKA-II) >2 ng/mL after 7 ± 2 days of enrolment.

Results

The prevalence of vitamin K deficiency was 100% (n=80) at enrolment and it remained 100% even after 7 ± 2 days of enrolment in both the groups.

Conclusion

Neonates receiving prolonged antibiotics have universal biochemical vitamin K deficiency despite vitamin K administration on 7th day of antibiotic therapy.

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Funding

Funding: None; Competing interests: None stated.

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Correspondence to Ramesh Agarwal.

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Sethi, A., Sankar, M.J., Thukral, A. et al. Prophylactic Vitamin K Administration in Neonates on Prolonged Antibiotic Therapy: A Randomized Controlled Trial. Indian Pediatr 56, 463–467 (2019). https://doi.org/10.1007/s13312-019-1569-4

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  • DOI: https://doi.org/10.1007/s13312-019-1569-4

Keywords

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