Observational studyBMJ paediatrics open2026
Challenges during clinical lactation studies investigating medicines exposure: experiences from the UmbrelLACT study - a contribution from the ConcePTION project.
Observational study in BMJ paediatrics open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06042803 (Clinical Lactation Study on the Exposure to Medicines Via Human Milk), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol
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Authors and funding
8 authors.
Funding
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Abstract
backgroundClinical lactation studies are valuable to guide pharmacotherapy during breastfeeding, but are not easy to conduct. This paper reports on challenges and mitigation strategies while conducting the UmbrelLACT study, a prospective observational lactation study.
methodsThe UmbrelLACT study includes breastfeeding women taking a relevant medicine (eg, absence of safety evidence during lactation) and after feasibility verification (eg, access to bioanalytical assay). Participants collect human milk samples at home over 24 hours. Optionally, maternal and infant blood samples are collected, together with self-reported questionnaires on clinical maternal and child variables. Medicine concentrations and estimated infant exposure (eg, daily and relative infant dose) are determined.
resultsRegarding informed consent, study objectives should be carefully phrased to prevent pharmacotherapy avoidance due to a lack of safety information. On sample collection, the study team should provide all necessary materials if not available at home, including an electric breast pump. Due to the milk expressions over 24 hours, the infant might miss soothing moments. This can be mitigated by giving the breast after expressing the milk for study purposes, creating alternative soothing moments. Sample handling might be complicated by additional steps needed for certain compounds. A bioanalysis method should be available or developed for the milk matrix. Finding the assay might be challenging, but it can be facilitated by a network of specialised labs. In the UmbrelLACT study, pharmacokinetic values are collected fragmentarily. This results in the need for data pooling with data from the literature. In contrast, at-home sampling and multidisciplinary collaboration are clear strengths.
conclusionsIt is feasible to tailor the approach to each participant and compound, to minimise the burden on the patient and their family. While there are limitations related to the pragmatic design, the opportunities of this lactation study outweigh the challenges to result in clinically significant scientific observations. TRIAL REGISTRATION NUMBER: NCT06042803.
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