SeizuresNCT01027715
The Impact of Electroencephalographic (EEG) Seizure Treatment in Neonatal Encephalopathy
A study testing EEG monitoring and treatment of EEG seizures in people with Seizures and Encephalopathy, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hours
- Conditions the study is for
- Seizures, Encephalopathy
- What is being tested?
- EEG monitoring and treatment of EEG seizures
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: 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).
Read the 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.
- Conditions
- Seizures, Encephalopathy
- Being tested
- EEG monitoring and treatment of EEG seizures
- Keywords
- Neonatal Seizures, Neonatal encephalopathy
- Medical subject headings
- Seizures, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoring and treatment of EEG seizuresOther
Also called EEG monitoring, Anti-epileptic drugs
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure burden
Measured: 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
Measured: first two years of life; 18-24 months
Secondary outcomes (6)
Time to seizure cessation
Measured: 2 to 3 years
Number, duration of anticonvulsants used and cumulative dose
Measured: 2 to 3 years
EEG background state
Measured: 2 to 3 years
Time to all per oral feeding
Measured: 2 to 3 years
Duration of hospital stay
Measured: 2 to 3 years
MRI measures from the Day #7-10 MRI in survivors
Measured: 2 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Mathur, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027715
- Sponsor's protocol ID
- 08-0888
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2009
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26482675
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Electroencephalographic (EEG) Seizure Treatment in Near Term ≥ 36 Weeks Gestation and Term Infants With Neonatal Encephalopathy
- ClinicalTrials.gov ID
- NCT01027715
- Acronym / sponsor ID
- 08-0888
- Conditions
- Seizures, Encephalopathy
- Keywords
- Neonatal Seizures, Neonatal encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG seizure treatment group | Experimental | Other: EEG monitoring and treatment of EEG seizuresEEG data available to physicians. Treatment based on EEG seizures. Treatment will be dictated by the detailed treatment protocol. Standard antiepileptic medications will be used. |
| 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. |
Who may qualify
- Ages
- 1 hour to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG monitoring and treatment of EEG seizuresAlso: EEG monitoring, Anti-epileptic drugsSeizures 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 | EEG seizure treatment group |
Primary outcome
Seizure burden
Time frame: 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
Time frame: first two years of life; 18-24 months
6 secondary outcomes
Time to seizure cessation
Time frame: 2 to 3 years
Number, duration of anticonvulsants used and cumulative dose
Time frame: 2 to 3 years
EEG background state
Time frame: 2 to 3 years
Time to all per oral feeding
Time frame: 2 to 3 years
Duration of hospital stay
Time frame: 2 to 3 years
MRI measures from the Day #7-10 MRI in survivors
Time frame: 2 to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Background: PubMed 26482675Srinivasakumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Mathur principal investigator
Washington University in Saint Louis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG monitoring and treatment of EEG seizures in people with Seizures and Encephalopathy, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure burden (time frame: 2 to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01027715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.