Late Vitamin K Deficiency-related Bleeding in Neonates (VKDB): Comparison of Four Different Strategies to Prophylaxis Measuring Proteins Induced by Vitamin K Absence (PIVKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age between 37+ 0/7 and 42+ 0/7 weeks
- •exclusive breastfeeding
- •Informed consent by at least one parent
排除标准
- •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
结局指标
主要结局
comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 months
时间窗: 3 months of life
PIVKA-II level measured by blood samples
次要结局
- to investigate the compliance and safety of oral vitamin K 1 administration(3 months of life)
研究者
Serafina Perrone
Director of Neonatology Unity, Department of Medicine and Surgery, University of Parma
Azienda Ospedaliero-Universitaria di Parma