RecruitingNot Applicable

UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk

Belgium30 participantsStarted 2023-02-01

Plain-language summary

The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are: * What is the concentration of maternal medicines in human milk? * What is the (estimated) intake and exposure in the breastfed infant? Participants will be asked to * fill out a questionnaire regarding medical data of the mother and child * track medication intake for 3 days * collect milk samples during 24 hours * optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child * fill out a questionnaire regarding the general health of the child.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * For breastfeeding women * Maternal age: ≥ 18 year * Currently exclusively or partially breastfeeding (/expressing milk) at the time of milk sampling * Using medicines for any indication, with at least 5 half-lives of the medicine taken * Willing to express and collect human milk * Signed informed consent to participate and for processing their personal data * For infants * Gestational age at birth: ≥24 weeks * Parental signed informed consent to participate and for processing their personal data Exclusion Criteria: * Maternal age \<18 years * Mother of twins * Not meeting the inclusion criteria

What they're measuring

The concentration of maternal medicines in human milk

Timeframe: 24 hours (sampling day)

Trial details

NCT IDNCT06042803

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Anne Smits, MD, PhD

+3216343565 anne.smits@uzleuven.be