Neonatal Intensive Care Unit, Westmead Hospital, Sydney, New South Wales, Australia.
School of Nursing and Midwifery, Western Sydney University, Sydney, New South Wales, Australia.
J Paediatr Child Health. 2024 Oct;60(10):561-568. doi: 10.1111/jpc.16645. Epub 2024 Aug 14.
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.
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.
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.
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.
在一项先导性随机对照试验中探索家长对同意过程的看法以及对研究的理解，该试验纳入的极早产儿（<29 周妊娠）是在产前或生后 4 小时内招募的。
我们前瞻性地调查了 Positioning Preterm Infants for Neuroprotection 研究中的已同意、拒绝同意或符合条件的婴儿的父母，该研究是一项在生命最初 72 小时内进行的低风险干预研究。结构访谈问题探讨了父母同意过程的可接受性及其对研究的了解。家长的其他意见则逐字转录。
62 位家长参与了调查；其中，41 位家长提供了同意，8 位家长拒绝了同意，13 位家长的婴儿不符合条件。总体而言，大多数家长表示在提供同意并同意之前，他们已经很好地理解了研究，并且同意过程并没有给他们带来负担。研究小组，特别是医疗从业者的口头解释被认为是有益的。在分娩单位（即将分娩和分娩后 4 小时内）获得同意时，获得产后同意的 4 小时期限可能太短。延迟同意并提供后续机会获得知情同意可能是一种合适的替代方案。
家长认为同意过程是可以接受的，并表示他们对研究有足够的了解，可以提供知情同意。对于未来的低风险干预研究，应该探讨延迟同意作为替代方案，以替代在新生儿期需要招募极早产儿的前瞻性同意。
