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

Not Applicable

Completed

• Conditions: Encephalopathy; Seizures
• Interventions: Other: EEG monitoring and treatment of EEG seizures

• Registration Number: NCT01027715
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This is a prospective, randomized, single-center 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.

The investigators hypothesize that the accurate detection and treatment of EEG seizures will decrease the seizure burden and improve outcomes in newborn infants with seizures and/or hypoxic-ischemic encephalopathy (HIE).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Study Start: 2010-01
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-08
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEG seizure treatment group	EEG monitoring and treatment of EEG seizures	EEG data available to physicians. Treatment based on EEG seizures. Treatment will be dictated by the detailed treatment protocol. Standard antiepileptic medications will be used.

Primary Outcome Measures

Name	Time	Method
Presence of a single combined event: death in the first two years of life or moderate or severe disability at 18-24 months	first two years of life; 18-24 months
Seizure burden	2 to 3 years

Secondary Outcome Measures

Name	Time	Method
EEG background state	2 to 3 years
Number, duration of anticonvulsants used and cumulative dose	2 to 3 years
Duration of hospital stay	2 to 3 years
MRI measures from the Day #7-10 MRI in survivors	2 to 3 years
Time to all per oral feeding	2 to 3 years
Time to seizure cessation	2 to 3 years

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States