Outcome After 24 Months of Participants in the TOBY Xenon Study

Guy's and St Thomas' NHS Foundation Trust

Status: Completed

Conditions: Perinatal Asphyxia; Encephalopathy

Treatments: Drug: Xenon

Study type: Observational

Funder types: Other

Identifiers

NCT03968861

IRAS157755

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 2 to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Surviving participants in the TOBY Xenon study

Exclusion criteria

Lack of consent to participate

Trial design

69 participants in 2 patient groups

Standard care with moderate hypothermia

Description:

Surviving children allocated to standard care with moderate hypothermia in the TOBY-Xe trial

30% Xenon for 24 hours combined with moderate hypothermia

Description:

Surviving children allocated to inhaled xenon combined with moderate hypothermia in the TOBY-Xe trial

Treatment:

Drug: Xenon