The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy
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).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Impact of Electroencephalographic (EEG) Seizure Treatment in Near Term ≥ 36 Weeks Gestation and Term Infants With Neonatal Encephalopathy|
- Seizure burden [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
- Presence of a single combined event: death in the first two years of life or moderate or severe disability at 18-24 months [ Time Frame: first two years of life; 18-24 months ] [ Designated as safety issue: No ]
- Time to seizure cessation [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
- Number, duration of anticonvulsants used and cumulative dose [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
- EEG background state [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
- Time to all per oral feeding [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
- Duration of hospital stay [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
- MRI measures from the Day #7-10 MRI in survivors [ Time Frame: 2 to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: EEG seizure treatment group
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.
Other: EEG monitoring and treatment of EEG seizures
Seizures will prompt treatment with loading doses of phenobarbital (20mg/kg), fosphenytoin (20mg/kg),and midazolam (0.05mg/kg bolus and .15mg/kg/hr infusion tapered over 48 hours)in that order for persisting seizures.
No Intervention: Clinical Seizure treatment Group
Seizure treatment in this group will be based on standard care - treating clinical seizures only. While EEG data will be collected in this group, the data will not be available to the treating physicians. A one-hour EEG report will be available to the treating team. Continuous EEG monitoring and treatment will only be allowed if the initial EEG shows status.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027715
|United States, Missouri|
|St. Louis Children's Hospital|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Amit Mathur||Washington University in Saint Louis|