Analgesia and breastfeeding: application of a physiology-based pharmacokinetic (PBPK) model for the prediction of the neonatal drug exposure. (SAFE-TAKE study)

The primary aims of this project are: 1. Record the dosing regimen and timing of exposure, measure the level of ketorolac and paracetamol in the milk and plasma of nursing mothers in the first 3 days after delivery; 2. Apply a PBPK model to estimate the pharmacological exposure of the breastfed newborn of nursing mothers in therapy with such drugs; 3. Obtain a limited number of neonatal samples to validate or, in case of discrepancies, adapt the predictions. The secondary aims of this project are: 1. Evaluate the impact of the delivery mode, maternal and neonatal clinical characteristics on drug disposition in maternal plasma, milk and neonatal plasma; 2. Validate dried milk spots as minimally invasive pharmacological diagnostic tools; 3. Survey parental and healthcare knowledge on drug safety issues during pregnancy and lactation.