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Parents' perceptions of their infants' participation in randomized controlled trials

Kim Cartwright1, Liam Mahoney, Susan Ayers

  • 1Developmental Brain Behaviour Laboratory, School of Psychology, University of Southampton, Highfield, Southampton, UK. klc3g08@soton.ac.uk

Journal of Obstetric, Gynecologic, and Neonatal Nursing : JOGNN
|January 26, 2012
PubMed

Insights

Parents generally had positive experiences when their infants participated in randomized control trials (RCTs). Ensuring parents

Area of Science:

  • Neonatal Research Ethics
  • Clinical Trial Participation
  • Parental Perceptions

Background:

  • Infant participation in randomized control trials (RCTs) is crucial for advancing neonatal care.
  • Understanding parental perspectives on infant involvement in clinical research is essential for ethical and effective trial conduct.

Purpose of the Study:

  • To explore parents' perceptions of their infants' participation in randomized control trials (RCTs).
  • To understand the implications of RCT participation for both the infant and the parents themselves.

Main Methods:

  • A qualitative study employing semistructured interviews with parents of infants who participated in RCTs.
  • Participants were recruited from neonatal intensive care units (NICUs) and via a charity's website.
  • Data were analyzed using systematic thematic analysis.

Main Results:

  • Five key themes emerged: initial reactions to enrollment approach, parent-clinician interactions, decision-making process, implications for parents, and effects on infants.
  • Parents reported mostly positive experiences regarding their infants' participation in RCTs.
  • The study highlighted the importance of addressing parents' individual needs throughout the research process.

Conclusions:

  • Clinicians should be encouraged to approach parents for infant enrollment in clinical research due to generally positive parental experiences.
  • Emphasizes the need for comprehensive support and attention to parents' individual needs from enrollment through follow-up in neonatal RCTs.
Abstract

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