Study on how medicines affect breastfeeding and infant exposure through human milk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.