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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01027715
First received: December 8, 2009
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Seizures
Encephalopathy
Other: EEG monitoring and treatment of EEG seizures

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
Arms Assigned Interventions
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.
Other Names:
  • EEG monitoring
  • Anti-epileptic drugs
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.

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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027715

Locations
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Amit Mathur Washington University in Saint Louis
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01027715     History of Changes
Other Study ID Numbers: 08-0888
Study First Received: December 8, 2009
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Neonatal Seizures
Neonatal encephalopathy

Additional relevant MeSH terms:
Seizures
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Poisoning
Substance-Related Disorders
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014