"Drugs in Lactation" Analysis Consortium (DLAC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Drug levels in breast milk
研究概览
简要总结
Some medications taken by the breastfeeding women are excreted into milk, posing a potential risk of toxicity to the infant. The first line of evidence required for toxicity risk assessment is prediction of drug levels in milk. However, pharmacokinetic (PK) information of drug excretion into milk is largely lacking, or limited to data from case reports. This makes it difficult to provide population-level prediction of drug levels in milk. The lack of data on this topic jeopardizes not only maternal adherence to drug therapy during breastfeeding but also establishment of breastfeeding, even if the drug is considered safe during nursing. Clearly, this clinical problem in drug safety is an important women's health issue, affecting both mother and infant. "Drugs in Lactation" Analysis Consortium (DLAC) is a "drug-in-milk" monitoring network, which is designed as a platform for efficient collection of patient milk samples in a real world setting to generate population predictions of drug excretion levels into human milk.
详细描述
OVERARCHING GOAL OF DLAC:
To establish a post-marketing "drug-in-milk" monitoring system for nursing women who are prescribed and using medications. Drugs in Lactation Analysis Consortium (DLAC) will provide risk assessment data and tools for toxicity detection in the form of population estimates and variations of drug levels in mother's milk and infant plasma for several common medications in a real world setting.
SPECIFIC OBJECTIVES:
- To generate data on drug levels in breast milk
- To develop a population pharmacokinetic model describing drug levels in milk
- To simulate/predict drug levels in milk in a population, based on the pop PK model
- To develop a physiologically-based pharmacokinetic (PBPK) model describing drug levels in infant serum
- To screen the breastfed infants of mothers on the study drugs for general health condition (medical issues, developmental milestones)
SCOPE AND RATIONALE:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old Taking one or more drugs of interest of the study, at steady state
排除标准
- •Being unable to communicate in English, Colostrum phase (<1 week postpartum)
结局指标
主要结局
Drug levels in breast milk
时间窗: Through the study completion, an average of 4 years
Robust parameter estimates from pop PK modelling usually require samples from \>30-50 individuals. Therefore, an average of 4 years is considered as the time frame, so that the required numbers of samples for each drug can be collected for population PK analysis and modelling.
次要结局
未报告次要终点
研究者
Shinya Ito
Division Head, Senior Scientist
The Hospital for Sick Children
