Single aortic sinus repair with double annular sutures in acute type A aortic dissection: a single center case series of seven patients.

Randomised controlled trials are the gold standard for evaluating clinical interventions, and obtaining informed consent is a fundamental ethical requirement for their conduct. In neonatal trials, consent is typically provided by parents on behalf of their infants. When randomisation is required soon after birth or in the delivery room, obtaining ethically valid prospective consent can present a major challenge in conducting neonatal trials []. Preterm birth is often rapid and unpredictable, and in such situations, time is critical. Seeking consent at the time of delivery has challenges. Mothers may be in pain, recovering from birth or receiving treatment, and both parents may experience considerable distress. Therefore, approaching families for trial participation and obtaining valid, informed consent under these circumstances can be challenging []. They may not be able to engage in a comprehensive consent procedure, while lengthy discussions can delay treatment allocation and compromise infant outcomes. Consequently, traditional written informed consent is not always feasible in trials involving preterm infants, especially in the delivery room setting. As such, alternative or complementary approaches are necessary to ensure equitable inclusion while maintaining ethical standards. One alternative is to use antenatal consent for women identified as at risk of preterm birth. Although this offers an important opportunity to support informed decision-making in advance, this approach has several challenges. Firstly, many infants identified as high risk antenatally may not ultimately require enrolment at birth, which can lead to inefficiencies in recruitment processes and the use of limited research staff in resource-constrained settings []. Secondly, even when consent is appropriately targeted to at-risk women, antenatal discussion of potential interventions may contribute to parental anxiety regarding complications that may ultimately never occur. Thirdly, restricting consent solely to the antenatal period excludes infants born unexpectedly or precipitously, as is common in preterm birth. Such infants are often the most critically ill and stand to benefit most from advances in care, and their exclusion may introduce selection bias [–]. Importantly, however, the possibility that an anticipated event may not occur does not negate the ethical value of offering antenatal information and consent, which can support respect for maternal autonomy when appropriately implemented within a risk-stratified approach.