Status:
COMPLETED
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Medical Research Council
Conditions:
Asphyxia Neonatorum
Hypoxia
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief 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 bod...
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 di...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00147030
Start Date
December 1 2002
End Date
August 1 2008
Last Update
May 11 2016
Active Locations (1)
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1
Hammersmith Hospital
London, United Kingdom, W12 0NN