Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants (CUDDLE)
Protocol Number: NICHD-2017-BMS01 IRB Protocol #20181205
Principal Investigators: Katherine L. Wisner, MD MS (Psychiatry)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is sponsoring a study nationwide to improve drug labels that guide how certain medications are prescribed for women who are breastfeeding.
Why is this research important?
Over half of women in the US who are breastfeeding their infants take prescription drugs. The drugs we are studying are commonly used by breastfeeding women and may pass into the breastmilk of mothers who take them to their child.
You are being asked to participate in this study because you are breastfeeding or are planning to breastfeed your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying.
We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of that drug is consumed by breastfed infants. Depending on the study results, the FDA may use the results from this study to improve the drug labels that guide how the study drugs of interest are prescribed in the U.S.
You may be eligible to participate if you:
- Are 18 years of age or older
- Are currently breastfeeding
- Speak English
- Taking one of our drugs of interest
- Your child is less than 6 months old
- Up to 8 study visits of blood draws (mother and/or infant) and manual expressing breastmilk for drug levels
- Demographics and questionnaires to assess for side effects
- (OPTIONAL) Questionnaires to follow the development of your child
- $50 for each completed study visit
If you are interested in participating or would like to hear more information, please contact our research team at email@example.com or 1-855-99-ASHER.