Critical issues with clinical research in children: The example of premature infants

Another crucial practical issue in pediatric research is how to power studies so that interventions can be studied adequately. In the US, large neonatal networks have been formed so that large databases can be created and large multi-center trials can be performed. The practical issues associated with these network studies is the center to center variability in patient care may dwarf the beneficial effect of the intervention on the disease process, so that a “negative” study of an intervention may not represent the true effect of the intervention in the disease process. These practical issues among others will be the focus of this review.