The frequency of randomized controlled trials on pharmacological therapies in newborn infants is going to increase following the active promotion initiatives of the European Community. Therefore, a high-risk baby might be eligible to participate in several research studies at the same time. Among the most important methodological and ethical aspects related to this possibility are the power of the studies, the interactions among treatments, the identification of side effects, the length of follow-up, the relationship with the parents and the expression of their consent; an important point is also the problem of possible claims for personal injuries following the clinical research. However, a methodologically appropriate and controlled experimentation of treatments, possibly under the verification and the guidance of well prepared and functioning Ethical Committees, is always better than the uncontrolled and unverified use of possibly efficacious but also possibly dangerous therapies.
|Translated title of the contribution||Newborns and multiple clinical experiments: Ahead with caution|
|Title of host publication||Quaderni ACP|
|Number of pages||3|
|Publication status||Published - 2009|
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health