TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Incidence of Mortality and Severe Neurodevelopmental Disability in Survivors |
74; 86 | — |
| SECONDARY Intracranial Haemorrhage |
25; 21 | — |
| SECONDARY Persistent Hypotension |
126; 134 | — |
| SECONDARY Pulmonary Haemorrhage |
5; 3 | — |
| SECONDARY Pulmonary Hypertension |
16; 9 | — |
| SECONDARY Prolonged Blood Coagulation Time |
67; 72 | — |
| SECONDARY Culture Proven Sepsis |
20; 20 | — |
| SECONDARY Necrotising Enterocolitis |
1; 0 | — |
| SECONDARY Cardiac Arrhythmia |
8; 3 | — |
| SECONDARY Thrombocytopenia |
94; 80 | — |
| SECONDARY Major Venous Thrombosis |
2; 1 | — |
| SECONDARY Renal Failure Treated With Dialysis |
0; 0 | — |
| SECONDARY Pneumonia |
5; 5 | — |
| SECONDARY Pulmonary Airleak |
9; 3 | — |
| SECONDARY Duration of Hospitalisation |
12; 13 | — |
| SECONDARY Mortality |
42; 44 | — |
| SECONDARY Severe Neurodevelopmental Disability |
32; 42 | — |
| SECONDARY Multiple Handicap |
21; 33 | — |
| SECONDARY Bayley Psychomotor Developmental Index Score (PDI) |
27; 37 | — |
| SECONDARY Sensorineural Hearing Loss |
110; 97 | — |
| SECONDARY Epilepsy (Defined as Recurrent Seizures Beyond the Neonatal Period, Requiring Anticonvulsant Therapy at the Time of Assessment) |
12; 16 | — |
| SECONDARY Microcephaly |
24; 28 | — |
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 = 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
Data sourced from ClinicalTrials.gov (NCT00147030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.