Determination of prednisolone concentration in human breast milk and plasma of breastfed infants: study protocol of a Swedish multicentre low-intervention clinical trial.

ABSTRACT:

Introduction

Many women need to use medications during breastfeeding. Very few medications have been adequately monitored, tested and labelled with safety information for this use. Prednisolone is one of these drugs. We aim to conduct a multicentre low-intervention clinical trial to determine the concentration of prednisolone in plasma of breastfed infants of lactating women treated with prednisolone. In addition, we will measure the concentration in maternal plasma and breast milk and calculate the daily infant dose (DID) and relative infant dose (RID). Infant cortisol levels will be analysed as a measure of clinical effects in the infants.

Methods and analysis

The study will be conducted at departments of obstetrics and gynaecology and specialist maternity and paediatric o

SUBMITTER: Svedenkrans J 

PROVIDER: S-EPMC12097052 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature