Late Vitamin K Deficiency-related Bleeding in Neonates (VKDB): Comparison of Four Different Strategies to Prophylaxis Measuring Proteins Induced by Vitamin K Absence (PIVKA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 months
Study Overview
Brief 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 months
- to 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 dosed
Researchers compared four groups of Vitamin K dosing regimens:
- an intramuscolar injection of 1 mg vitamin K at birth
- an 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.
Detailed Description
Partecipanting Centers
- Azienda Ospedaliera Universitaria di Parma
- Azienda Ospedaliera Universitaria di Siena
- Ospedale Buon Consiglio Fatebenefratelli, Napoli
- Ospedale Di Venere, Bari
Materials and Methods Term healthy newborn born from March 2019 to June 2021 was enrolled Vitamin K formulation was Konakion 2 mg/0,2 ml MM paediatric, solution for injection or oral administration, Cheplapharm Arzneimittel GMBH
PIVKA level was was measured on blood drops obtained by heel prick at 48 hours of life, 1 month and 3 months, using the PIVKA-II ELISA Kit, MyBiosource, San Diego, CA, USA.
Blood samples (0,5 ml) were collected in Lithium Heparine draw. After centrifugation at 1000 rpm for 15 minutes plasma was frozen and stored at -20°C. The samples were subsequently analyzed in the Laboratorio di Patologia Clinica, Università degli Studi di Siena.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 1 Day (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •gestational age between 37+ 0/7 and 42+ 0/7 weeks
- •exclusive breastfeeding
- •Informed consent by at least one parent
Exclusion Criteria
- •gestational age less than 37+ 0/7 weeks or more than 42+0/7 weeks
- •neonatal disease
- •liver disease
- •formula milk or mixed milk feeding
- •withdrawal of informed consent
Outcomes
Primary Outcomes
comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 months
Time Frame: 3 months of life
PIVKA-II level measured by blood samples
Secondary Outcomes
- to investigate the compliance and safety of oral vitamin K 1 administration(3 months of life)
Investigators
Serafina Perrone
Director of Neonatology Unity, Department of Medicine and Surgery, University of Parma
Azienda Ospedaliero-Universitaria di Parma