Encephalopathy Clinical Trial
Official title:
Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
The objective of this study is to document the outcome at 2-3 years of age of participants of
the TOBY Xe trial, to provide preliminary information about the later clinical effects of
treatment with Xenon gas combined with moderate hypothermia following perinatal asphyxia. The
TOBY Xe trial was a randomised controlled trial of inhaled xenon gas combined with
hypothermia for the treatment of perinatal asphyxia. The trial primary outcome was changes on
magnetic resonance parameters examined prior to discharge from hospital.
Continuing clinical follow-up of trial participants is important following any therapeutic
trial and is essential in early phase trials where information on the clinical effects of the
intervention are lacking. Therefore, we have set up this study to determine the major
clinical and neurological outcomes of participants of the TOBY Xe trial and to determine
whether the magnetic resonance parameters in that trial are qualified to predict outcome
following neural rescue therapy. This information is necessary for planning further studies
of this intervention.
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