Abstract
BackgroundAlthough recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial.MethodsParents of former participants of five neonatal interventional drug trials were surveyed at long term (3–13 years ago) after participation. The survey assessed parental contentment with trial participation, perceived influence of the trial on care and health, emotional consequences of participation, and awareness of typical clinical trial characteristics on 6-point Likert scales.ResultsComplete responses were received from 123 parents (52% of involved families). Twenty percent of parents did not remember participation. Those who remembered participation reported high contentment with overall trial participation (median 5.00), but not with follow-up (median 3.00). Most parents did not perceive any influence of the trial on care (median 2.00) and health (median 2.43). Almost all parents reported satisfaction and pride (median 4.40), while a minority of parents reported anxiety and stress (median 1.44) or guilt (median 1.33) related to trial participation. A relevant minority was unaware of typical trial characteristics (median 4.20; 27% being unaware).ConclusionsOverall, parents reported positive experiences and little emotional distress long term after participation. Future efforts to improve the practice of neonatal clinical trials should focus on ensuring effective communication about the concept and characteristics of a clinical trial during consent discussions and on the follow-up after the trial.
Highlights
Recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care
Remembering trial participation was not significantly correlated to sex, age, parental education, or outcome of the child (Supplementary Table 4)
Remembrance was strongly correlated to the trial (p = 0.016), with especially lower remembrance (61%) in NEOPROP, the most recent clinical trial (Supplementary Table 5)
Summary
Recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their neonate in a clinical trial, especially at long term. The objective of this study is to assess experiences and emotions of parents, long term after trial participation in an interventional drug trial. Enrollment in trials in the neonatal intensive care unit (NICU) often occurs at a moment when parents are Salaets et al Trials (2020) 21:907 overwhelmed by stress and emotions. There is a lack of empirical data on how parents evaluate participation in a neonatal drug trial and on how the trial affects their emotional well-being [6]. We assessed the perspectives and emotions of parents long term after participation in an interventional drug trial conducted in the NICU. Parental understanding of the trial was assessed and neonatal outcome data collected in order to evaluate possible correlations
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