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

Completed · Not applicable

Conditions studied: Seizures, Encephalopathy

In brief

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).

Key facts

Study ID

NCT01027715

Run by

Washington University School of Medicine

People needed

69

Starts

2010-01-01

Expected to finish

2015-12-01

Last updated by the study team

2015-12-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Louis Children's Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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