NCT03968861

Outcome After 24 Months of Participants in the TOBY Xenon Study

Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 2 Years – 3 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Perinatal Asphyxia
• Encephalopathy

Interventions

Type	Name	Description
DRUG	Xenon	Inhaled xenon gas given via purposely designed ventilator

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-06-01
• Completion: 2018-05-01
• First posted: 2019-05-30
• Last updated: 2019-05-30

Locations

3 sites across 1 country: United Kingdom