This is a pilot study which will test the safety and feasibility of hypothermia treatment as adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates versus conventional treatment (dialysis, nutritional therapy, and ammonia scavenging drugs) only. The endpoint of the pilot study will be reached when either 24 patients have been enrolled and no serious adverse events were observed, when no patient has been enrolled in 5 years, or when serious adverse events occur which are clearly linked to the use of hypothermia. These would be serious complications not seen in patients on conventional therapy (dialysis , nutritional therapy, ammonia scavenging drugs) for HAE.
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Number of Participants with unexpected Serious Adverse Events as a Measure of Safety and Tolerability
Timeframe: Participants will be followed for the duration of the hospital stay, an expected average of 5 weeks
Feasibility of hypothermia therapy as adjunct therapy to the complex standard of care therapy
Timeframe: During the first 72h of treatment