PANNA-B TDM

Information for healthy participants

Purpose

The purpose of this study is to determine how much of the antiretroviral drugs ingested by the mother ends up in breastmilk and consequently in the baby who drinks the breastmilk.

Background

You and your physician have decided that you will breastfeed your baby while taking antiretroviral drugs. It is unknown to what extent these drugs penetrate in breastmilk. If a lot of it ends up in breastmilk, this could lead to side effects in the baby that drinks the milk. If the amount of drugs in milk is very low, it is probably safe. If it is somewhere in between, it may lead to development of a resistant virus. If the baby gets infected with HIV – the chances of this happening are very low – this may impede its treatment.
To make a well thought out decision on combining breastfeeding with the intake of antiretroviral drugs, it is important to know how much of these drugs end up in breastmilk. This study will examine this.

Study procedures

If you take part in the study, blood from you and your baby will be examined, ideally after 1,3 and 6 months your baby is born. No extra needle sticks are needed, this blood will be drawn during the regular blood draw for follow up. Also, you are asked to pump breastmilk and donate 2ml for our study. The remaining milk can be fed to your baby. It is possible to donate extra breastmilk and/or blood during the hospital visit (2 to 4 hours later), if you wish.
You and your baby may participate more or less often, which ever suits you best. Participation 6 months after your baby is born, is not allowed.

Figure 1 schematic view of study. Greed dots indicate follow up visits in the hospital. Ideally, blood and milk is collected from you - and if possible blood from your baby as well- 1,3 and 6 months after your baby is born. Other moments are also possible (dotted lines)
Private rooms for pumping are provided. If you do not own a electric breastpump, one can be borrowed from the hospital.

Compensation

For each time blood and breastmilk is collected, you will receive a €25,- voucher.

More information

For more information or registration, please contact us:
[email protected]