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Comparative Study
. 2019 Jun;36(7):759-764.
doi: 10.1055/s-0038-1675157. Epub 2018 Oct 31.

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials

I Blaire Hanvey  1 , Sofia Aliaga  1 , Matthew M Laughon  1 , Daniela Testoni  2 , P Brian Smith  3   4 , Melissa Bauserman  1
Affiliations
Comparative Study

Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials

I Blaire Hanvey et al. Am J Perinatol. 2019 Jun.

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.

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Conflict of interest statement

None.

Figures

Fig. 1
Fig. 1
Summary of systematic search presented as Consolidated Standards of Reporting Trials diagram.
See this image and copyright information in PMC

References

    1. Betan EJ, Roberts EC, McCluskey-Fawcett K. Rates of participation for clinical child and pediatric psychology research: issues in methodology. J Clin Child Psychol 1995;24(02):227–235
    1. Hamvas A, Madden KK, Nogee LM, et al. Informed consent for genetic research. Arch Pediatr Adolesc Med 2004;158(06):551–555 - PubMed
    1. Hayman RM, Taylor BJ, Peart NS, Galland BC, Sayers RM. Participation in research: informed consent, motivation and influence. J Paediatr Child Health 2001;37(01):51–54 - PubMed
    1. Stenson BJ, Becher JC, McIntosh N. Neonatal research: the parental perspective. Arch Dis Child Fetal Neonatal Ed 2004;89(04):F321–F323 - PMC - PubMed
    1. Rothmier JD, Lasley MV, Shapiro GG. Factors influencing parental consent in pediatric clinical research. Pediatrics 2003;111 (5 Pt 1):1037–1041 - PubMed