NCT00147030

TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia

Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 1 Hour – 6 Hours
• Healthy volunteers: Not accepted

Summary

Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability. This study aims to determine whether whole body cooling to 33-34°C is a safe treatment that improves survival, without severe neurological or neurodevelopmental impairments at 18 months, of term infants suffering perinatal asphyxial encephalopathy.

Detailed description

This is a multicentre prospective randomised controlled trial to determine whether a reduction of body temperature by 3-4°C following perinatal asphyxia improves survival without neurodevelopmental disability. Full term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 ± 0.2°C or to whole body cooling with the rectal temperature kept at 33.5 ± 0.5°C for 72 hours followed by slow rewarming. The outcome will be assessed at 18 months of age by survival and neurological and neurodevelopmental testing. Eligibility criteria: Term infants less than 6 hours after birth with moderate or severe perinatal asphyxia (a combination of clinical and EEG criteria). Exclusion criteria: Infants expected to be 6 hours of age at the time of randomisation or infants with major congenital abnormalities. Intervention: Intensive care with whole body cooling versus intensive care without whole body cooling (babies are cooled to 33.5°C for 72 hours) Main Outcomes: Death and severe neurodevelopmental impairment at 18 months of age Secondary Outcomes: Cerebral thrombosis or haemorrhage, persistent hypotension, pulmonary hypertension, abnormal coagulation, arrhythmia and sepsis in the neonatal period. Neurological impairments at 18 months Number of patients required: 236. On 30th November 2006, when recruitment closed, 325 babies had been recruited.

Conditions

• Asphyxia Neonatorum
• Hypoxia
• Encephalopathy
• Seizures

Interventions

Type	Name	Description
PROCEDURE	Whole body mild induced hypothermia	Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia

Timeline

• Start date: 2002-12-01
• Primary completion: 2006-11-01
• Completion: 2008-08-01
• First posted: 2005-09-07
• Last updated: 2016-05-11
• Results posted: 2016-05-11

Locations

1 site across 1 country: United Kingdom