Study on how medicines affect breastfeeding and infant exposure through human milk
Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol
This study is trying to see how different medicines affect breast milk and how much of those medicines babies might get when breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06042803 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine the concentration of various medicines in human milk during maternal medication intake and to estimate the exposure of breastfed infants to these medicines. Participants, including breastfeeding mothers and their infants, will complete questionnaires about their medical history, track medication intake for three days, and collect milk samples over a 24-hour period. Additionally, mothers may provide blood samples, and consent for a blood sample from the infant may also be requested. The study seeks to fill the information gap regarding the safety of medications during lactation, which is crucial for informed decision-making about breastfeeding and pharmacotherapy.
Who should consider this trial
Good fit: Ideal candidates include breastfeeding women aged 18 and older who are currently using medications and willing to participate in milk and blood sample collection.
Not a fit: Patients who are not breastfeeding, those under 18 years of age, or mothers of twins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical data to support safe medication use during breastfeeding, potentially improving adherence to both breastfeeding and necessary pharmacological treatments.
How similar studies have performed: While there is limited data on this specific approach, the study addresses a significant gap in existing literature regarding medication safety during lactation, suggesting a novel and necessary investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leuven, Vlaams-Brabant
- Universitaire Ziekenhuizen KU Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Anne Smits, MD PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Anne Smits, MD, PhD
- Email: anne.smits@uzleuven.be
- Phone: +3216343565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.