Clinical research in newborn infants: difficulties and specificity

Eur J Clin Pharmacol. 2011 May:67 Suppl 1:29-32. doi: 10.1007/s00228-010-0921-3. Epub 2010 Nov 18.

Abstract

Background: Clinical trials are essential in neonates to evaluate scientifically the efficacy and safety of drugs. However, major specificities condition clinical research in human neonates.

Objective: To review specific constraints to be taken into account in neonatal research studies.

Methods: A review of the literature and contribution of authors' opinions was carried out.

Results and conclusion: Neonatal specificities that induce obstacles in neonatal studies and proposals are detailed. This review also looks at recommendations recently developed by the European Commission to promote safe and ethical research in neonatology.

Publication types

  • Review

MeSH terms

  • Biomedical Research / ethics*
  • Biomedical Research / methods*
  • Clinical Trials as Topic / ethics*
  • Clinical Trials as Topic / methods*
  • Humans
  • Infant, Newborn*
  • Neonatology / ethics*
  • Neonatology / methods*