The ethics of neonatal research: A trialists' perspective.

We are neonatal physicians who strive to practice evidence-based medicine. We conduct and promote randomized trials in preterm and critically ill infants to improve their care and outcomes. Controlled clinical trials are ethical and essential because randomization is the best strategy to minimize bias when evaluating therapies of uncertain benefit. Perinatal and neonatal randomized trials have identified better care practices, uncovered useless or harmful therapies, and revealed new knowledge gaps. We are convinced that neonatal randomized trials can be done safely and in partnership with the infants' families.