Clinical trials in neonates: The FP7 TINN experience

In the recent years, several major progresses have been achieved in neonatal care, with an increased understanding of the perinatal risks and sequels. However, the evaluation of medicines in neonates remains very limited, with more than 90% of drugs being used unlabelled in neonatal intensive care units (NICUs). Neonates constitute a peculiar population that can be affected by unique diseases (respiratory distress syndrome, patent ductus arteriosus, primary pulmunary hypertension, infections) and unique susceptibilities, which can even be more frequent in pre-terms (necrotising enterocolitis, retinopathy of prematurity, intraventricular hemorrahage, neurodevelopmental toxicity). In addition, there are important pharmacological parameters that affect drug disposition and effects in neonatal period and have to be taken into account in the evaluation of a treatment, such as the gestational and post natal ages, the immaturity of the renal hepatic clearance mechanisms, and the CNS distribution of the medicinal products.