Am J Perinatol 2019; 36(07): 759-764
DOI: 10.1055/s-0038-1675157
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials

I. Blaire Hanvey
1   Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina
,
Sofia Aliaga
1   Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina
,
Matthew M. Laughon
1   Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina
,
Daniela Testoni
2   Escola Paulista de Medicina–Universidade Federal de São Paulo, Brazil
,
P. Brian Smith
3   Department of Pediatrics, Duke University Medical Center, Durham, North Carolina
4   Duke Clinical Research Institute, Durham, North Carolina
,
Melissa Bauserman
1   Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina
› Institutsangaben
Funding None.
Weitere Informationen

Publikationsverlauf

09. Oktober 2017

02. September 2018

Publikationsdatum:
31. Oktober 2018 (online)

Abstract

Objective The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates.

Study Design 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.

Results 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).

Conclusion 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.

Authors' Contributions

I.B.H. and S.A. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: M.M.L., I.B.H., M.B., S.A., D.T. Acquisition, analysis, or interpretation of data: I.B.H., S.A., M.B., D.T. Drafting of the manuscript: I.B.H. Critical revision of the manuscript for important intellectual content: M.B., M.M.L., S.A., P.B.S., D.T. Statistical analysis: I.B.H. Administrative, technical, or material support: M.B., M.M.L. Study supervision: M.B., M.M.L., P.B.S.


 
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