Medication Concentrations in Human Milk (MedMilk) and Potential Adverse Effects in Breastfed Infants: an Exploratory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Drug concentrations in human milk
研究概览
简要总结
The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding
详细描述
The MedMilk (Medication concentrations in human Milk) study is a prospective, exploratory clinical study coordinated by the Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Denmark. The study is observational in nature and involves no experimental drug administration. Participants are breastfeeding women using medicines as part of their routine treatment.
Each participant will provide four small breast milk samples (1-20 mL each) collected at different time points in relation to maternal drug intake, one urine sample, and questionnaire data on maternal and infant health, breastfeeding patterns, and any infant symptoms potentially related to drug exposure. Samples are stored at -80 °C in a dedicated research biobank until analysis.
Drug concentrations in milk and urine will primarily be quantified using solid Phase Extraction coupled with UPLC-MS/MS. Data will be analyzed descriptively, and relative infant doses (RID) will be calculated. For drugs with sufficient sampling density.
Results will add to the limited body of systematic data on drug transfer into human milk and help inform clinical decision-making regarding medication use during breastfeeding.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Lactating women aged ≥18 years
- •Current use of one or more prescription or over-the-counter (classified within the ATC system) drugs
- •Able and willing to provide written informed consent
排除标准
- •Current pregnancy during sample collection
- •Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling
研究组 & 干预措施
Breastfeeding women on medication
干预措施: Prescription Drugs (Drug)
结局指标
主要结局
Drug concentrations in human milk
时间窗: Within one dosing interval
Quantification of drug concentrations in human milk, expressed in micrograms per millilitre (µg/mL). Milk samples are collected before and after the maternal dose within one dosing interval.
次要结局
- Relative Infant Dose (RID)(Within one dosing interval)
- Maternal-reported infant adverse effects(At the time of inclusion. Montly follow-up for three months.)
研究者
Jón Þór Trærup Andersen
Professor, PhD,
University Hospital Bispebjerg and Frederiksberg