Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials.
Journal
American journal of perinatology
ISSN: 1098-8785
Titre abrégé: Am J Perinatol
Pays: United States
ID NLM: 8405212
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
pubmed:
1
11
2018
medline:
28
5
2020
entrez:
1
11
2018
Statut:
ppublish
Résumé
The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates. We included neonatal drug trials published between 2009 and 2014 and compared parental consent rates among the following characteristics: phase type, gestational age, randomization type, drug administration route, drug dosing frequency, blood sampling, control type, length of study, funding source, and length of treatment. We compared characteristics using chi-square, Fisher's exact, one-way analysis of variance or Kruskal-Wallis tests. We identified 52 trials: 38 trials (73%) reported data of parental consent. Median percentage (interquartile range) of parental consent was 79% (62, 89). Higher rates were observed in studies that used active comparators (87%) and shorter study lengths (81% for studies <24 hours). Parental consent rates for neonatal drug trials varied by study characteristics. Information on proportion of parents consented is valuable to assess generalizability of trial results and for preparing trial protocols.
Identifiants
pubmed: 30380581
doi: 10.1055/s-0038-1675157
pmc: PMC8565499
mid: NIHMS1748424
doi:
Types de publication
Comparative Study
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
759-764Subventions
Organisme : NHLBI NIH HHS
ID : K24 HL143283
Pays : United States
Informations de copyright
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Déclaration de conflit d'intérêts
None.
Références
Ned Tijdschr Geneeskd. 2004 Jan 24;148(4):186-90
pubmed: 14974312
Cochrane Database Syst Rev. 2009 Jan 21;(1):MR000006
pubmed: 19160345
BMJ. 2010 Mar 23;340:c332
pubmed: 20332509
BMJ Open. 2013 May 28;3(5):
pubmed: 23793670
Arch Dis Child Fetal Neonatal Ed. 2006 Sep;91(5):F374-6
pubmed: 16923938
J Paediatr Child Health. 2001 Feb;37(1):51-4
pubmed: 11168870
Pediatrics. 2004 Apr;113(4):727-32
pubmed: 15060219
Arch Dis Child Fetal Neonatal Ed. 2005 May;90(3):F267-9
pubmed: 15846021
Arch Pediatr Adolesc Med. 2004 Jun;158(6):551-5
pubmed: 15184218
Pediatrics. 1997 Jan;99(1):E6
pubmed: 9096174
J Med Ethics. 1992 Jun;18(2):86-93
pubmed: 1619628
J Pediatr Health Care. 2011 Jan-Feb;25(1):1-2
pubmed: 21147401
Pediatrics. 2003 May;111(5 Pt 1):1037-41
pubmed: 12728085
Pediatrics. 2008 Mar;121(3):e590-6
pubmed: 18310179
Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F321-3
pubmed: 15210665
BMJ. 1990 May 26;300(6736):1372-5
pubmed: 2372582
Curr Opin Pediatr. 2005 Feb;17(1):20-4
pubmed: 15659958