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J Obstet Gynecol Neonatal Nurs. 2011 Sep-Oct;40(5):555-65. doi: 10.1111/j.1552-6909.2011.01276.x.

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

Author information

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

Abstract

OBJECTIVE:

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

DESIGN:

A qualitative study using semistructured interviews.

SETTING:

Participants were identified from neonatal intensive care unit (NICU) clinical registers and from responses to an advertisement put on the website of United Kingdom special care baby charity, BLISS. Interviews were conducted with parents face-to-face in their homes or over the telephone.

PARTICIPANTS:

Sixteen parents of 12 infants born prematurely or with complications at full term and who had participated in one of three RCTs while receiving intensive care in one of seven NICUs.

METHODS:

Interviews were audio-taped or digitally recorded, transcribed verbatim, and analyzed using systematic thematic analysis using WinMax qualitative software.

RESULTS:

Five main themes emerged from the data. The themes were parents' immediate reactions to being approached about RCT enrollment, interactions between parents and clinicians upon the approach of enrollment and during the RCT, making the decision to enroll their infants, implications of the RCT for parents, and effects of the RCT on the infants.

CONCLUSIONS:

Clinicians should be encouraged to approach parents about enrollment of their infants in clinical research given that parents reported mostly positive experiences related to this participation. However, appropriate measures should be taken to ensure that the individual needs of parents are being met throughout the entire research process from enrollment to follow-up.

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