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.
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.
Authors: April V P Clyburne-Sherin; Pravheen Thurairajah; Mufiza Z Kapadia; Margaret Sampson; Winnie W Y Chan; Martin Offringa Journal: Trials Date: 2015-09-18 Impact factor: 2.279