Drug studies in newborns: a therapeutic imperative

Clinics in Perinatology
George P GiacoiaAnne Zajicek

Abstract

Although some drugs have been developed for the neonate, drug development for the least mature and most vulnerable pediatric patients is lacking. Most of the drugs are off-label or off-patent and are empirically administered to newborns once efficacy has been demonstrated in adults and usefulness is suspected or demonstrated in the older pediatric population. Few drugs are approved by the Food and Drug Administration for use in this population. The factors that prevent the demonstration of efficacy and safety in the newborn are discussed and a change in the current approach for neonatal drug studies is suggested.

References

Nov 1, 1979·The Journal of Pediatrics·E BancalariJ Gannon
Jul 3, 1978·European Journal of Pediatrics·M GabrielM Albani
Sep 1, 1991·Pediatric Neurology·S P WeinerM S Scher
Dec 1, 1987·Neurology·E M Mizrahi, P Kellaway
Feb 16, 1967·The New England Journal of Medicine·W H NorthwayD Y Porter
Dec 4, 1998·BMJ : British Medical Journal·N BadawiF J Stanley
Mar 3, 2001·Pediatric Research·G L Holmes, Y Ben-Ari
Feb 1, 2002·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Imti Choonara, Sharon Conroy
Apr 30, 2002·Archives of Disease in Childhood. Fetal and Neonatal Edition·G B BoylanC D Binnie
Apr 3, 2003·Pediatrics·UNKNOWN Committee on Fetus and Newborn. American Academy of Pediatrics
Sep 13, 2003·Journal of Paediatrics and Child Health·P A SteerB G Charles
Jan 30, 2004·American Journal of Obstetrics and Gynecology·Steven P MillerJ Colin Partridge
Oct 21, 2004·The Cochrane Database of Systematic Reviews·D Henderson-Smart, P Steer
Oct 22, 2004·Pediatric Research·Agnes I BarthaDonna M Ferriero
Nov 3, 2004·Pediatrics·Michele C WalshUNKNOWN National Institute of Child Health and Human Development Neonatal Research Network
Jun 17, 2006·Pediatrics·Billie Lou ShortUNKNOWN Cardiology Group
May 8, 2007·The Journal of Pharmacology and Experimental Therapeutics·Irina KatzAlexei Kondratyev
Nov 9, 2007·The New England Journal of Medicine·Barbara SchmidtUNKNOWN Caffeine for Apnea of Prematurity Trial Group
Jun 13, 2008·Brain Research·Amy M BlackJerome Y Yager
Aug 12, 2008·Current Clinical Pharmacology·Karel AllegaertJan de Hoon
Mar 3, 2009·Drug Metabolism and Pharmacokinetics·Brian J Anderson, Nick H G Holford
Jul 18, 2009·Pharmaceutical Statistics·Pravin R JadhavJogarao V S Gobburu
Sep 17, 2009·European Journal of Clinical Pharmacology·Antje NeubertWolfgang Rascher
Jul 28, 2010·Neurotoxicity Research·Ortrud UckermannChrysanthy Ikonomidou
Sep 4, 2010·Clinics in Perinatology·Pak C Ng, Hugh S Lam
Sep 11, 2010·Genome Medicine·Richard A Polin, Tara M Randis
Oct 30, 2010·Annals of Neurology·Lex W DoyleTerrie E Inder
Jan 20, 2011·Journal of Paediatrics and Child Health·Peter H GrayUNKNOWN Caffeine Collaborative Study Group
Apr 8, 2011·American Journal of Respiratory and Critical Care Medicine·Matthew M LaughonUNKNOWN Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
Apr 30, 2011·International Journal of Developmental Neuroscience : the Official Journal of the International Society for Developmental Neuroscience·Sandra ReesDavid Walker
Jul 27, 2011·Neuroscience Bulletin·Lian ZhangXiao-Ping Luo
Nov 5, 2011·The Journal of Pediatrics·Seetha ShankaranUNKNOWN Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
Nov 19, 2011·Journal of Perinatology : Official Journal of the California Perinatal Association·M D SatputeS W Aucott
Jan 13, 2016·The Journal of Maternal-fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·Lingping ZhangXuesong Zhai

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Citations

Feb 7, 2014·European Journal of Pediatrics·Alcidésio SouzaHelena Coelho
Jan 23, 2016·BMC Pediatrics·Alcidésio Sales de SouzaHelena Lutéscia Luna Coelho
Sep 4, 2012·Thrombosis Research·A BruceM P Massicotte
Feb 22, 2014·Advanced Drug Delivery Reviews·M A TurnerUNKNOWN Global Research in Paediatrics
Sep 3, 2014·Journal of Perinatology : Official Journal of the California Perinatal Association·R M Viscardi
Sep 27, 2018·PloS One·Haline Tereza Matias de Lima CostaAntônio Gouveia Oliveira
Oct 4, 2015·The Journal of Pharmacology and Experimental Therapeutics·Sigrid BjørnstadRagnhild Elisabeth Paulsen
Jun 5, 2019·American Journal of Therapeutics·Alona Bin-NunYair M Kasirer
Feb 9, 2020·Pharmacy : Journal of Pharmacy, Education and Practice·Kate O'HaraJennifer J Schneider
May 22, 2019·Paediatrics & Child Health·Marie-Kim HérautJean-François Bussières

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