Women sometimes need medicines. This is true in all stages of life, also after having a baby. Breastfeeding is often encouraged, but we don’t know enough about the amount of medicine being transferred to breastmilk. The UmbrelLACT study will collect data on how a mother’s medicines transfer from her blood to her breastmilk, to what extent the child is exposed to the drug compound in question, and the general health outcome of the child. As part of the ConcePTION project, they have developed a generic study protocol for how to collect this data.
As the name indicates, the UmbrelLACT study takes an umbrella approach to clinical lactation studies – to make sure data collection and analysis is as efficient as possible. Before, researchers had to prepare a new study for each medicine that was to be studied – a very time-consuming way of working. Now, the UmbrelLACT study offers a universal protocol adaptable to different medicines. This flexibility allows for quicker, more responsive research, crucial for studying breastfeeding, which occurs only for a limited time. The study protocol is outlined in an article recently published in BMJ Paediatrics Open.
“The data we collect can provide new insights into the medicine transfer from the mother’s bloodstream to human milk, and the nursing infant. With ethics and biobank approval, we hope to recruit 5-15 women per year through UZ Leuven, the BELpREG project, the Belgian pregnancy registry, and other healthcare facilities,” says Martje Van Neste, MD and PhD Student at KU Leuven, and one of the authors of the paper.
The UmbrelLACT study protocol allows for adaptable sample collection, with the option to add maternal and children’s blood collection in addition to human milk and medical characteristics. From these samples, researchers can then calculate the concentration of the drug compound in milk versus blood (milk-to-plasma ratio) and to which extent the child is exposed to the compound in question, the so-called daily and relative infant dose.
“Another important feature of the study is our ability to use it also to evaluate different prediction models. Our lactation and paediatric PBPK models allow us to predict the concentration that reaches the human milk and the child. But these need to be accurate. And here, we are offered an opportunity to check this accuracy,” says Nina Nauwelaerts, PhD Student at KU Leuven, shared first author of the paper.
According to the authors, their study protocol provides a generic workflow that can be utilized also by others – if adapted to local regulation. And to close the knowledge gap about medicine safety in pregnancy and breastfeeding, many contributors are needed.
By Anna Holm Bodin
Van Neste, M., Nauwelaerts, N., Ceulemans, M., Van Calsteren, K., Eerdekens, A., Annaert, P., Allegaert, K., & Smits, A. Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project, BMJ Paediatrics Open 2024;8:e002385. DOI: 10.1136/bmjpo-2023-002385