The infant will be assessed sequentially by criteria A, B and C listed below: A. Infants ≥ 36 completed weeks gestation admitted to the 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 aEEG (read by trained personnel): C. At least 30 minutes duration of aEEG 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
Azzopardi D., Brocklehurst P., Edwards D., Halliday H., Levene M., Thoresen M, & Whitelaw A. (2008). The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: A randomised controlled trial. BMC Pediatrics, 8, 17.
Other organizations :
Imperial College London, University of Oxford, Princess Royal Maternity Hospital, Leeds General Infirmary, St Michaels Hospital, Southmead Hospital, University of Bristol
Infants ≥ 36 completed weeks gestation admitted to the 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
dependent variables
Presence of 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
Abnormal background aEEG activity or seizures (normal background with some seizure activity, moderately abnormal activity, suppressed activity, continuous seizure activity)
control variables
Infants assessed sequentially by criteria A, B and C
positive controls
Not explicitly mentioned
negative controls
Not explicitly mentioned
Annotations
Based on most similar protocols
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