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

8. december 2015 opdateret af: Washington University School of Medicine

The Impact of Electroencephalographic (EEG) Seizure Treatment in Near Term ≥ 36 Weeks Gestation and Term Infants With 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63110
        • St. Louis Children's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 time til 3 dage (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andre navne:
  • EEG monitoring
  • Anti-epileptic drugs
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Seizure burden
Tidsramme: 2 to 3 years
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
Tidsramme: first two years of life; 18-24 months
first two years of life; 18-24 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Efterforskere

  • Ledende efterforsker: Amit Mathur, Washington University in Saint Louis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

8. december 2009

Først indsendt, der opfyldte QC-kriterier

8. december 2009

Først opslået (Skøn)

9. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 08-0888

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med EEG monitoring and treatment of EEG seizures

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