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Published on: January 12, 2018
Parental views on prospective consent: Experience from a pilot randomised trial recruiting extremely preterm infants
Hannah Skelton1,2, Traci-Anne Goyen1, Patricia Viola1
1Neonatal Intensive Care Unit, Westmead Hospital, Sydney, New South Wales, Australia.
Insights
Parents found the informed consent process acceptable for extremely premature infants. A deferred consent approach may be suitable for future low-risk neonatal studies.
Area of Science:
- Neonatal Research
- Clinical Trials
- Informed Consent
Background:
- Recruiting extremely premature infants (<29 weeks' gestation) for clinical trials presents unique challenges for obtaining informed consent.
- Parental understanding and perceptions of the consenting process are crucial for ethical research conduct.
Purpose of the Study:
- To explore parental perceptions of the informed consenting process in a pilot randomized controlled trial for extremely premature infants.
- To assess parental understanding of a low-risk intervention study conducted within the first 72 hours of life.
Main Methods:
- Prospective survey of parents who consented, declined consent, or were eligible but not consented in the "Positioning Preterm Infants for Neuroprotection" study.
- Structured interviews assessed the acceptability and parental knowledge of the consenting approach.
- Verbatim transcription of additional parent comments.
Main Results:
- Most parents (62 surveyed) reported good understanding of the study prior to consent.
- Verbal explanations by medical practitioners were perceived as beneficial.
- The 4-hour window for postnatal consent in the birthing unit was considered potentially too short, suggesting deferred consent as an alternative.
Conclusions:
- The consenting process was acceptable to parents, who felt adequately informed.
- Deferred consent should be explored for future low-risk intervention studies involving immediate neonatal recruitment.
Aim:
To explore parental perceptions of the consenting process and understanding of the study in a pilot randomised controlled trial wherein extremely premature infants (<29 weeks' gestation) were recruited either antenatally or by 4 h of life.
Methods:
We prospectively surveyed parents who had consented, declined consent or were eligible infants in the Positioning Preterm Infants for Neuroprotection study, a low-risk intervention study in the first 72 h of life. Structured interview questions explored the process and acceptability of the consenting approach by the parents and their knowledge of the study. Additional comments made by the parents were transcribed verbatim.
Results:
Sixty-two parents participated in the surveys; of those, 41 had provided their consent, 8 declined consent and 13 were parents of missed eligible infants. Overall, most parents reported they understood the study well before providing their consent and approaching them for consenting did not create a burden for them. A verbal explanation of the study by the study team, especially by the medical practitioners, was viewed as beneficial. Where consent was obtained in the birthing unit (imminent births and within 4 h of birthing), it was suggested that the 4-h period for obtaining post-natal consent may be too short. A deferred consent with a follow-up opportunity for obtaining informed consent could be a suitable alternative.
Conclusion:
Parents found the consenting process acceptable and indicated they had sufficient understanding of the study to provide an informed consent. Deferred consent should be explored for future, low-risk intervention studies as an alternative to prospective consent where extremely preterm infants need to be recruited in the immediate neonatal period.
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