Prophylactic Vitamin K Administration in Neonates on Prolonged Antibiotic Therapy : A Randomized Controlled Trial
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.
INTERVENTIONS: Randomized to receive 1 mg vitamin K (n=41) or no vitamin K (n=39) on the 7th day of antibiotic therapy.
MAIN OUTCOME MEASURES: 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.
CONCLUSIONS: Neonates receiving prolonged antibiotics have universal biochemical vitamin K deficiency despite vitamin K administration on 7th day of antibiotic therapy.
Errataetall: |
CommentIn: Indian Pediatr. 2019 Jun 15;56(6):459-460. - PMID 31278222 |
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Medienart: |
E-Artikel |
Erscheinungsjahr: |
2019 |
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Erschienen: |
2019 |
Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
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Enthalten in: |
Indian pediatrics - 56(2019), 6 vom: 15. Juni, Seite 463-467 |
Sprache: |
Englisch |
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Beteiligte Personen: |
Sethi, Amanpreet [VerfasserIn] |
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Themen: |
12001-79-5 |
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Anmerkungen: |
Date Completed 04.02.2020 Date Revised 04.02.2020 published: Print CTRI: CTRI/2017/02/007776 CommentIn: Indian Pediatr. 2019 Jun 15;56(6):459-460. - PMID 31278222 Citation Status MEDLINE |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
NLM298916851 |
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500 | |a CommentIn: Indian Pediatr. 2019 Jun 15;56(6):459-460. - PMID 31278222 | ||
500 | |a Citation Status MEDLINE | ||
520 | |a 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 | ||
520 | |a STUDY DESIGN: Open label randomized controlled trial | ||
520 | |a SETTING: Level 3 Neonatal Intensive Care Unit (NICU) | ||
520 | |a 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 | ||
520 | |a INTERVENTIONS: Randomized to receive 1 mg vitamin K (n=41) or no vitamin K (n=39) on the 7th day of antibiotic therapy | ||
520 | |a MAIN OUTCOME MEASURES: Vitamin K deficiency defined as Protein Induced by Vitamin K Absence (PIVKA-II) >>2 ng/mL after 7 ± 2 days of enrolment | ||
520 | |a 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 | ||
520 | |a CONCLUSIONS: Neonates receiving prolonged antibiotics have universal biochemical vitamin K deficiency despite vitamin K administration on 7th day of antibiotic therapy | ||
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