Actively Recruiting
UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-02-27
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
I
Innovative Medicines Initiative
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Breastfeeding women aged 18 years or older
- Currently exclusively or partially breastfeeding or expressing milk at the time of milk sampling
- Using medicines for any reason, with at least five half-lives of the medicine taken
- Willing to express and collect human milk
- Signed informed consent to participate and for processing personal data
- Infants born at 24 weeks gestation or later
- Parental signed informed consent for infant participation and data processing
You will not qualify if you...
- Maternal age under 18 years
- Mother of twins
- Not meeting the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universitaire Ziekenhuizen KU Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
A
Anne Smits, MD, PhD
CONTACT
M
Martje Van Neste, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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