UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Maternal age <18 years
Mother of twins
Not meeting the inclusion criteria
Trial design
Treatments tested in this trial
- Human milk collection
- Optionally: maternal blood sample
- Optionally: child blood sample
Treatment groups
No treatment groups listed
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Innovative Medicines Initiative
Collaborator
BELpREG
Collaborator
Source ClinicalTrials.gov