The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy

This is a prospective, randomized, pilot trial of term and near term (≥ 36 weeks gestation)
infants with encephalopathy or seizures comparing a "EEG Seizure Treatment Group" or ESG
with a "Clinical Seizure Treatment Group" or CSG. Eligibility is based on clinical criteria
for moderate/severe encephalopathy or seizures. We will recruit near term or term infants (≥
36 weeks gestation) with a diagnosis of seizures or encephalopathy admitted to the neonatal
intensive care unit (NICU) at St. Louis Children's Hospital within the first 72 hours of
life. Infants will be randomized into an EEG Seizure Treatment Group (ESG) or a Clinical
Seizure Treatment Group (CSG) (n=20 in each group). Patients in both groups will have EEG
monitoring. While treating physicians will have access to EEG data in the ESG, no EEG data
in the CSG will be available to the clinician for treatment of seizures. AED treatment will
be initiated/escalated using stringent EEG seizure criteria (EST) or clinical criteria (CST)
with the goal being seizure cessation. The specific AED, dosage, and duration of treatment
is standardized in both groups. Monitoring will continue for a period of upto 96 hours in
both arms. Other than the anticonvulsant drugs, treatment thresholds and dosing schedules,
treatment in both arms will be at the discretion of the bedside physician.All infants will
undergo an assessment of neuromotor disability and neurodevelopmental evaluation at 18 to 24
months.

Inclusion Criteria:

- Term or near term infants ≥ 36 weeks gestation admitted to the neonatal intensive
care unit

- ≤ 72 hours of age

- Screening for the "at risk" infant by the clinical team to include any one of the
following:

- Apgar score <5 at 5 min

- Cord blood or postnatal gas with pH <7.0 or BE > -12

- Need for respiratory support at 10 min of life

- Suspected or definite seizures

- Encephalopathy defined by recognition of altered neurological behavior

- Infants identified in the above screen will be examined by the research team and will
be eligible if they satisfy at least one of the following:

- Moderate-severe neonatal encephalopathy (3 out of 6 criteria)

- Suspected or definite neonatal seizures

Exclusion criteria:

- Infants < 36 weeks gestation

- > 72 hours of age

- Infants with congenital anomalies of the central nervous system

- Moribund infants for whom no further aggressive treatment is planned

- Metabolic disorders or documented CNS infection

- Neuro-muscular blockade