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- W2898891447 abstract "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." @default.
- W2898891447 created "2018-11-09" @default.
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- W2898891447 date "2018-10-31" @default.
- W2898891447 modified "2023-10-03" @default.
- W2898891447 title "Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials" @default.
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- W2898891447 doi "https://doi.org/10.1055/s-0038-1675157" @default.
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