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Clinical trials

Parental Consent in Neonatal Clinical Studies: New Insights

Strategic Insights

— 1 min read

A new study published in Acta Paediatrica has shed light on the reasons behind parental decline of participation in neonatal clinical studies. The research, conducted between June 2022 and April 2023, aimed to explore the factors influencing parents' decisions to decline participation in a study investigating the transfer of faecal filtrate for the prevention of necrotising enterocolitis. The study found that emotional, logistical, and societal factors played a significant role in parents' decision-making.

Key Takeaways:

  • The study involved 10 parents, all first-time parents, who declined participation in the PrePhage study, a study investigating the transfer of faecal filtrate for the prevention of necrotising enterocolitis.
  • Three themes were identified: uncertainty of the unknown, challenges and discomfort related to sample collection, and balancing societal expectations.
  • The study found that early parenthood influenced willingness to engage in research, with parents expressing uncertainty about the unknown consequences of participating in clinical studies.
  • The burden of sample collection, particularly for faecal samples, was a significant challenge for parents, leading to discomfort and reluctance to participate.
  • Societal expectations also played a role, with parents feeling pressure to participate in research while also expressing guilt for declining participation.

Statistics:

  • 10 parents participated in the study, all of whom were first-time parents.
  • The study was conducted between June 2022 and April 2023.
  • 5 mothers and 5 fathers participated in the study.
  • 3 themes were identified through thematic analysis of the qualitative data.
  • 10 different newborn infants were involved in the study.
  • The PrePhage study was a clinical trial investigating the transfer of faecal filtrate for the prevention of necrotising enterocolitis (NCT05272579 and NCT05272566).

Sources:

  • NewsRp. Findings from Copenhagen University Hospital Provide New Insights into Science (Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations). Clinical Trials Week. October 20, 2025; p 1037.
  • Parental Consent to a Neonatal Clinical Study: The Roles of Uncertainty, Burden of Sample Collection and Societal Expectations. Acta Paediatrica, 2025.
  • Wiley. Acta Paediatrica. (www.wiley.com;) (onlinelibrary.wiley.com/journal/10.1111/(ISSN)1651-2227)

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