Ahmed H Shafeeq
Bangalore Medical College and Research Institute, Bengaluru, India.
J Paediatr Child Health. 2025 Mar;61(3):306-315. doi: 10.1111/jpc.16787. Epub 2025 Jan 26.
Bubble Continuous Positive Airway Pressure (bCPAP) has become a crucial intervention in neonatal care, particularly in resource-limited settings where access to advanced respiratory support is scarce. While bCPAP offers a cost-effective solution for neonatal respiratory distress, conducting clinical trials in these settings presents significant ethical challenges. Issues of justice, beneficence, and autonomy arise due to disparities in healthcare infrastructure, complexities surrounding informed consent, and the potential exploitation of vulnerable populations.
In this study, I examine the ethical principles essential to the design and implementation of bCPAP trials, focusing on justice, beneficence, and autonomy within the constraints of resource-limited settings. A normative analysis was conducted, drawing on key ethical frameworks to establish guiding principles for conducting ethically sound bCPAP trials.
Applying frameworks such as Rawls' theory of distributive justice and Sen's capability approach, I argue for prioritizing neonatal populations in low-resource settings while addressing the potential for exploitation. Autonomy underscores the need for informed consent processes that are culturally appropriate and accessible, empowering caregivers in decision-making. Beneficence and non-maleficence are evaluated through both utilitarian and deontological perspectives, balancing the potential benefits of innovation against the risks to participants. Structural inequities that complicate neonatal care and research are also critically examined.
I advocate for the integration of ethical safeguards, including community-centered consent processes, rigorous trial protocols, and international collaboration to mitigate systemic inequities. By incorporating these ethical considerations, bCPAP research can better serve the interests of neonates and their families while ensuring their safety and dignity are upheld.
气泡式持续气道正压通气（bCPAP）已成为新生儿护理中的一项关键干预措施，尤其是在资源有限的环境中，那里获得先进呼吸支持的机会稀缺。虽然bCPAP为新生儿呼吸窘迫提供了一种具有成本效益的解决方案，但在这些环境中进行临床试验存在重大的伦理挑战。由于医疗保健基础设施的差异、知情同意的复杂性以及对弱势群体的潜在剥削，出现了公正、行善和自主等问题。
在本研究中，我审视了bCPAP试验设计和实施所必需的伦理原则，重点关注资源有限环境限制下的公正、行善和自主。进行了规范性分析，借鉴关键的伦理框架来确立开展符合伦理的bCPAP试验的指导原则。
应用诸如罗尔斯的分配正义理论和森的能力方法等框架，我主张在低资源环境中优先考虑新生儿群体，同时应对潜在的剥削问题。自主性强调需要有符合文化且可及的知情同意程序，使护理人员在决策中有权力。通过功利主义和道义论的视角对行善和不伤害进行评估，平衡创新的潜在益处与对参与者的风险。还对使新生儿护理和研究复杂化的结构性不平等进行了批判性审视。
我主张整合伦理保障措施，包括以社区为中心的同意程序、严格的试验方案和国际合作，以减轻系统性不平等。通过纳入这些伦理考量，bCPAP研究能够更好地服务于新生儿及其家庭的利益，同时确保维护他们的安全和尊严。
