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

Launched by IMPERIAL COLLEGE LONDON · Sep 5, 2005

Keywords

ClinConnect Summary

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:

Te...

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• The infant will be assessed sequentially by criteria A, B and C listed below:
• A. Infants =\>36 completed weeks gestation admitted to the Neonatal Intensive Care Unit (NICU) with at least one of the following:
• • Apgar score of =\<5 at 10 minutes after birth
• • Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
• • Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH \<7.00)
• • Base Deficit =\>16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth
• Infants that meet criteria A will be assessed for whether they meet the neurological abnormality entry criteria (B) by trained personnel:
• B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:
• • hypotonia
• • abnormal reflexes including oculomotor or pupillary abnormalities
• • absent or weak suck
• • clinical seizures
• Infants that meet criteria A \& B will be assessed by amplitude-integrated electroencephalogram (aEEG) (read by trained personnel):
• C. At least 30 minutes duration of amplitude integrated EEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
• • normal background with some seizure activity
• • moderately abnormal activity
• • suppressed activity
• • continuous seizure activity
• • Exclusion criteria
• • Infants expected to be \> 6 hours of age at the time of randomisation
• • Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis

Trial Officials