NCT01027715

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

5.9 years

First QC Date

December 8, 2009

Last Update Submit

December 8, 2015

Conditions

SeizuresEncephalopathy

Keywords

Neonatal SeizuresNeonatal encephalopathy

Outcome Measures

Primary Outcomes (2)

  • Seizure burden

    2 to 3 years

  • 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

Secondary Outcomes (6)

  • Time to seizure cessation

    2 to 3 years

  • Number, duration of anticonvulsants used and cumulative dose

    2 to 3 years

  • EEG background state

    2 to 3 years

  • Time to all per oral feeding

    2 to 3 years

  • Duration of hospital stay

    2 to 3 years

  • +1 more secondary outcomes

Study Arms (2)

EEG seizure treatment group

EXPERIMENTAL

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

Clinical Seizure treatment Group

NO INTERVENTION

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.

Interventions

EEG monitoring and treatment of EEG seizuresOTHER

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.

Also known as: EEG monitoring, Anti-epileptic drugs
EEG seizure treatment group

Eligibility Criteria

Age1 Hour - 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Srinivasakumar P, Zempel J, Trivedi S, Wallendorf M, Rao R, Smith B, Inder T, Mathur AM. Treating EEG Seizures in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial. Pediatrics. 2015 Nov;136(5):e1302-9. doi: 10.1542/peds.2014-3777. Epub 2015 Oct 19.

    PMID: 26482675BACKGROUND

MeSH Terms

Conditions

SeizuresBrain Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System Diseases

Study Officials

  • Amit Mathur

    Washington University in Saint Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

US(1)