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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00147030
• Date of registration: 05/09/2005
• Prospective Registration: No
• Primary sponsor: Imperial College London
• Public title: TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
• Scientific title: Whole Body Hypothermia for the Treatment of Perinatal Asphyxial Encephalopathy
• Date of first enrolment: December 2002
• Target sample size: 325
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00147030
• Study type: Interventional
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Denis Azzopardi, MD; FRCPCH
• Affiliation: Imperial College London

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 6 Hours
Gender: All

Health Condition(s) or Problem(s) studied

Asphyxia Neonatorum

Encephalopathy

Seizures

Hypoxia

Intervention(s)

Procedure: Whole body mild induced hypothermia

Primary Outcome(s)

Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors [Time Frame: 18 months]

Secondary Outcome(s)

Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment) [Time Frame: 18 months]

Bayley Psychomotor Developmental Index Score (PDI) [Time Frame: 18 months]

Duration of Hospitalisation [Time Frame: Duration of hospital stay, on average 22 days]

Multiple Handicap [Time Frame: 18 months]

Pneumonia [Time Frame: Before discharge from hospital]

Renal Failure Treated With Dialysis [Time Frame: Duration of hospital stay, on average 22 days]

Thrombocytopenia [Time Frame: Duration of hospital stay, on average 22 days]

Culture Proven Sepsis [Time Frame: Duration of hospital stay, on average 22 days]

Sensorineural Hearing Loss [Time Frame: 18 months]

Pulmonary Airleak [Time Frame: Duration of hospital stay, on average 22 days]

Microcephaly [Time Frame: 18 months]

Prolonged Blood Coagulation Time [Time Frame: Duration of hospital stay, on average 22 days]

Major Venous Thrombosis [Time Frame: Duration of hospital stay, on average 22 days]

Persistent Hypotension [Time Frame: Duration of hospital stay, on average 22 days]

Cardiac Arrhythmia [Time Frame: Duration of hospital stay, on average 22 days]

Intracranial Haemorrhage [Time Frame: Duration of hospital stay, on average 22 days]

Mortality [Time Frame: 18 months]

Necrotising Enterocolitis [Time Frame: Duration of hospital stay, on average 22 days]

Pulmonary Haemorrhage [Time Frame: Duration of hospital stay, on average 22 days]

Pulmonary Hypertension [Time Frame: Duration of hospital stay, on average 22 days]

Severe Neurodevelopmental Disability [Time Frame: 18 months]

Secondary ID(s)

ISRCTN89547571(1)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Council

Results

• Results available: Yes
• Date Posted: 11/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00147030