Citrate-functionalized manganese oxide nanoparticles in neonates ≥35 weeks gestation at risk of acute bilirubin encephalopathy: a phase 1 observational trial
In compliance with institutional processes, we initiated a three-step project proposal that would eventually lead to a single-center, placebo-controlled, randomized controlled trial of this experimental nanodrug. We initiated a request to the Indian Council of Medical Research (ICMR, New Delhi) to sponsor our clinical research proposal seeking a multi-center investigation. Concurrently, anticipating a lengthy process, we also sought institutional approval…
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