Neonatal selection of study design and clinical follow-up outcomes are usually defined by the scientific community, without any parental input. This investigation aimed to inquire on parental perspectives prior to implementation of new trials of mild hypoxic ischemic encephalopathy (HIE).

Neonatal neuroprotection strategies are still in development and few therapies have withstood the long transition from pre-clinical to Phase III trials. Therapeutic hypothermia (TH) has transformed the landscape of treatment of HIE and remains the only proven intervention to mitigate poor neurodevelopmental outcomes in infants with moderate and severe encephalopathy. However, for infants with mild HIE who were not included in the trials, the fundamental question of how to manage remains problematic.1 While this topic persisted in yearly panels, commentaries, and opinions, no new randomized clinical trial (RCT) data have emerged to support or refute treatment. An increasing therapeutic drift is rendering a multicenter neonatal RCT for mild HIE challenging to perform, and the loss of equipoise may be difficult to accept.2 Some scientists believe that only RCTs can provide efficacy evidence as they have the advantage of strong internal validity, while others justify effectiveness of more pragmatic approaches as applicable for a real-world setting, seeing external validity and feasibility as justifiable trade-offs.

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