Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
L-C&Y, KU Leuven Child & Youth Institute, Leuven, Belgium.
BMJ Paediatr Open. 2024 Apr 10;8(1):e002385. doi: 10.1136/bmjpo-2023-002385.
Breastfeeding is beneficial for the health of the mother and child. However, at least 50% of postpartum women need pharmacotherapy, and this number is rising due to the increasing prevalence of chronic diseases and pregnancies at a later age. Making informed decisions on medicine use while breastfeeding is often challenging, considering the extensive information gap on medicine exposure and safety during lactation. This can result in the unnecessary cessation of breastfeeding, the avoidance of pharmacotherapy or the off-label use of medicines. The UmbrelLACT study aims to collect data on human milk transfer of maternal medicines, child exposure and general health outcomes. Additionally, the predictive performance of lactation and paediatric physiologically based pharmacokinetic (PBPK) models, a promising tool to predict medicine exposure in special populations, will be evaluated.
Each year, we expect to recruit 5-15 breastfeeding mothers using pharmacotherapy via the University Hospitals Leuven, the BELpREG project (pregnancy registry in Belgium) or external health facilities. Each request and compound will be evaluated on relevance (ie, added value to available scientific evidence) and feasibility (including access to analytical assays). Participants will be requested to complete at least one questionnaire on maternal and child's general health and collect human milk samples over 24 hours. Optionally, two maternal and one child's blood samples can be collected. The maternal medicine concentration in human milk will be determined along with the estimation of the medicine intake (eg, daily infant dose and relative infant dose) and systemic exposure of the breastfed child. The predictive performance of PBPK models will be assessed by comparing the observed concentrations in human milk and plasma to the PBPK predictions.
This study has been approved by the Ethics Committee Research UZ/KU Leuven (internal study number S67204). Results will be published in peer-reviewed journals and presented at (inter)national scientific meetings.
NCT06042803.
母乳喂养对母婴健康都有益处。然而，至少有 50%的产后女性需要药物治疗，由于慢性病和高龄妊娠的患病率不断增加，这个数字还在不断上升。在母乳喂养期间，考虑到有关药物暴露和哺乳期安全性的信息差距广泛，做出有关药物使用的明智决策常常具有挑战性。这可能导致不必要地停止母乳喂养、避免药物治疗或药物的标签外使用。UmbrelLACT 研究旨在收集有关母体药物在人乳中的转移、儿童暴露和一般健康结果的数据。此外，还将评估泌乳和儿科生理基于药代动力学（PBPK）模型的预测性能，这是一种预测特殊人群药物暴露的有前途的工具。
每年，我们预计通过鲁汶大学医院、BELpREG 项目（比利时妊娠登记处）或外部卫生机构招募 5-15 名接受药物治疗的母乳喂养母亲。每个请求和化合物都将根据相关性（即对现有科学证据的增值）和可行性（包括获取分析检测）进行评估。参与者将被要求至少完成一份关于母婴一般健康的问卷，并收集 24 小时的人乳样本。还可以选择采集两份母乳样本和一份儿童血液样本。将测定人乳中母体药物的浓度，并估算药物摄入量（例如，每日婴儿剂量和相对婴儿剂量）和母乳喂养儿童的全身暴露量。通过比较母乳和血浆中的观察浓度与 PBPK 预测值来评估 PBPK 模型的预测性能。
这项研究已获得鲁汶大学医院/鲁汶天主教大学伦理委员会研究（内部研究编号 S67204）的批准。研究结果将发表在同行评议的期刊上，并在（国际）科学会议上展示。
NCT06042803。
