title: Clinical research in newborn infants: difficulties and specificity.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Neonatology, La Conception Hospital, Assistance Publique-Hôpitaux de Marseille and Faculté de Médecine, Université de la Méditerranée, Marseille, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Ligi
authors.forename: Farid
authors.initials: F
authors.lastname: Boubred
authors.forename: Isabelle
authors.initials: I
authors.lastname: Grandvuillemin
authors.forename: Umberto
authors.initials: U
authors.lastname: Simeoni
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000379:methods*; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods*; D006801:Humans; D007231:Infant, Newborn; D009359:Neonatology / Q000941:ethics* / Q000379:methods*