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Completed
NCT05713045
Late Vitamin K Deficiency-related Bleeding in Neonates (VKLB): Comparison of Different Strategies to Prophylaxis
Conditions: Late Vitamin K Deficiency-related Bleeding
Sex: All
Ages: 1 Day – 1 Day
Enrollment: 80
Sponsor: Azienda Ospedaliero-Universitaria di Parma
Location: Italy
Summary
The goal of this multicentric observational study was to compare four vitamin K dosing regimens in exclusively breastfed healthy term newborns.
The main questions it aims to answer were:comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 monthsto investigate the compliance and safety of oral vitamin K 1 administration Participants received vitamin K prophilaxis according to birth Hospital regimen.
A blood sample was taken at 48 hours, 1 month and 3 months of life.
Plasmatic PIVKA-II concentretion was be dosedResearchers compared four groups of Vitamin K dosing regimens:an intramuscolar injection of 1 mg vitamin K at birthan intramuscolar injection of 1 mg vitamin K at birth followed by 50 μg/die orally from the second to the fourteenth week of life.an intramuscolar injection of 1 mg vitamin K at birth followed by 150 μg/die orally from the second to the fourteenth week of life.an oral dose of 2 mg vitamin K at birth, followed by a second dose at 4 weeks, and a third dose at 12 weeks to see if there is PIVKA-II plasmatic concentration differences.
Eligibility Criteria
Inclusion Criteria:gestational age between 37+ 0/7 and 42+ 0/7 weeksexclusive breastfeedingInformed consent by at least one parentExclusion Criteria:gestational age less than 37+ 0/7 weeks or more than 42+0/7 weeksneonatal diseaseliver diseaseformula milk or mixed milk feedingwithdrawal of informed consent
Source: ClinicalTrials.gov (NCT05713045). StuddyBuddy aggregates publicly available trial information.
