Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to find out how long the drug hydroxyurea stays in the body and how it is passed into breastmilk when given to lactating women.
We also want to determine if the amount of hydroxyurea passed into the breastmilk is safe to infants of breast feeding women who have sickle cell disease (SCD).
What will happen in the study?
If you qualify for this study and agree to participate, you will have 1 study visit. You will be in this study for 2 days.
The following is a list of procedures that may take place during the study visit:
- Questions about your general medical health (initial evaluation)
- Medical history
- Hydroxyurea therapy
- Blood samples
- Urine samples
- Urine pregnancy test
- Breastmilk samples
You will first have an initial evaluation. During the evaluation, study staff will ask you questions about your general health and medical history.
After the initial evaluation, you will begin the hydroxyurea therapy part of the study.
You will be given 1 dose of hydroxyurea. If this is your first ever dose of hydroxyurea, and you have not already been prescribed hydroxyurea, you will be asked to not directly breastfeed your baby and to discard all pumped breast milk for 8 hours after you receive the dose of hydroxyurea. You will feed your baby previously pumped breast milk, before the dose, or other nutrition during this time.
If you have sickle cell disease and are already on hydroxyurea treatment, you will be asked to continue to breastfeed your infant throughout the study.
Blood samples, urine samples and breastmilk samples will all be collected at various time points throughout your study visit (from before you take the dose of hydroxyurea to up to 12 hours after you take the dose of hydroxyurea).
Study staff will monitor you for the development of side effects throughout the day of your study visit and for 1 day after you take the medication. You will be asked to come back 1 day after your visit to return a sample of breastmilk and urine, which will be collected at home.
Clinical data, including the results of standard lab tests, may be collected from your medical record. Access to all identifying and clinical information will be restricted to only the study doctor of this research study and his designees. This data will be stored in a secure database at Cincinnati Children’s.
You as a participant will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
Will you/your child be paid to be in this research study?
Participants may receive up to $150 for their time and effort.