{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,5]],"date-time":"2026-01-05T07:29:18Z","timestamp":1767598158885,"version":"3.38.0"},"reference-count":42,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,1,26]],"date-time":"2025-01-26T00:00:00Z","timestamp":1737849600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Paediatrics Child Health"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Bubble Continuous Positive Airway Pressure (bCPAP) has become a crucial intervention in neonatal care, particularly in resource\u2010limited settings where access to advanced respiratory support is scarce. While bCPAP offers a cost\u2010effective 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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\u2010limited settings. A normative analysis was conducted, drawing on key ethical frameworks to establish guiding principles for conducting ethically sound bCPAP trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Applying frameworks such as Rawls' theory of distributive justice and Sen's capability approach, I argue for prioritizing neonatal populations in low\u2010resource 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\u2010making. Beneficence and non\u2010maleficence 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>I advocate for the integration of ethical safeguards, including community\u2010centered 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.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jpc.16787","type":"journal-article","created":{"date-parts":[[2025,1,27]],"date-time":"2025-01-27T05:41:10Z","timestamp":1737956470000},"page":"306-315","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Ethical Dilemmas in Clinical Trials of Innovations in Bubble Continuous Positive Airway Pressure Models in Resource\u2010Limited Neonatal Care"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1671-8474","authenticated-orcid":false,"given":"H. Shafeeq","family":"Ahmed","sequence":"first","affiliation":[{"name":"Bangalore Medical College and Research Institute  Bengaluru India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,1,26]]},"reference":[{"key":"e_1_2_17_2_1","doi-asserted-by":"publisher","DOI":"10.1891\/0730\u20100832.35.3.125"},{"key":"e_1_2_17_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40985\u2010020\u201000124\u20107"},{"key":"e_1_2_17_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12098\u2010011\u20100651\u20102"},{"key":"e_1_2_17_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/s2213\u20102600(19)30243\u20107"},{"key":"e_1_2_17_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild\u20102013\u2010305519"},{"key":"e_1_2_17_7_1","doi-asserted-by":"publisher","DOI":"10.4159\/9780674042605"},{"key":"e_1_2_17_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/0199252653.001.0001"},{"volume-title":"Realizing Rawls","year":"1989","author":"Pogge T.","key":"e_1_2_17_9_1"},{"key":"e_1_2_17_10_1","first-page":"1","article-title":"Pathologies of Power: Health, Human Rights, and the New War on the Poor. 1st ed","volume":"6","author":"Farmer P.","year":"2003","journal-title":"University of California Press"},{"volume-title":"Development as Freedom","year":"1999","author":"Sen A.","key":"e_1_2_17_11_1"},{"key":"e_1_2_17_12_1","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9780511606250"},{"volume-title":"Groundwork of the Metaphysics of Morals","year":"1996","author":"Kant I.","key":"e_1_2_17_13_1"},{"volume-title":"Nicomachean Ethics","year":"2009","author":"Aristotle","key":"e_1_2_17_14_1"},{"volume-title":"Capital: A Critique of Political Economy","year":"1990","author":"Marx K.","key":"e_1_2_17_15_1"},{"volume-title":"Justice and the Politics of Difference","year":"1990","author":"Young I. 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