One newborn who received the drug died after his family decided to transition to palliative care, a choice parents sometimes make when their child has important brain damage. No child in the placebo group died.The study therefore concludes that sildenafil is safe and well absorbed by babies who have developed brain damage due to neonatal encephalopathy and in whom therapeutic hypothermia has proved ineffective. This is the first proof-of-concept study to attempt to repair the brain damage caused by neonatal encephalopathy.
Between 2016 and 2019, Dr. Wintermark and her team were finally able to proceed with the first phase of the clinical study involving 24 babies born at 36 weeks of gestation or more, with moderate to severe neonatal encephalopathy, who had been placed on therapeutic hypothermia and had brain damage despite treatment. Using sildenafil in babies with such sequelae despite therapeutic hypothermia was found “feasible and safe”.
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