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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Sep 11, 2023

Keywords

ClinConnect Summary

The UmbrelLACT Study is a research project aimed at understanding how medicines taken by breastfeeding mothers can affect their breast milk and, ultimately, the babies who are fed with that milk. The main goals of the study are to measure the amount of medication that ends up in breast milk and to estimate how much of that medication a breastfed baby might actually ingest. This information can help ensure the safety of breastfeeding mothers who need to take medications.

To participate in this study, mothers must be at least 18 years old, currently breastfeeding (either exclusively or partially), and taking certain medications. They will need to complete a questionnaire about their and their child's health, track their medication intake for three days, and collect samples of their breast milk over a 24-hour period. Additionally, mothers can choose to provide two blood samples, and give consent for one blood sample from their child. The study is currently recruiting participants, and it’s important for mothers of twins or those under 18 to know that they are not eligible to join. This study aims to provide valuable insights for mothers and healthcare providers about the safety of medications during breastfeeding.

Gender

FEMALE

Eligibility 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