Critically IllNCT02925988
Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates
A study testing EEG monitoring in people with Critically Ill, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Over the past decade, technical advances have improved the efficiency of continuous EEG recording and remote review, leading to a steep increase in the number of continuous EEGs performed, and to an emerging change in what is considered the standard of care with regards to brain monitoring. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Critically Ill
- What is being tested?
- EEG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Jan 2017to 22 Apr 2018
- 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 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates admitted to our NICU
- Neonates identified to require aEEG monitoring as per current NICU guidelines (all neonates receiving therapeutic hypothermia as well as neonates with clinical events suggestive of seizures)
Who cannot join
- Neonates not eligible for EEG monitoring (e.g. patients with extensive cephalhematoma or subgaleal hemorrhage, interfering with the application of electrodes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates: A Pilot Study
Over the past decade, technical advances have improved the efficiency of continuous EEG recording and remote review, leading to a steep increase in the number of continuous EEGs performed, and to an emerging change in what is considered the standard of care with regards to brain monitoring. Critically ill patients are at high risk for CNS insults, which can result in permanent neurologic disability if untreated. Non-convulsive status epilepticus and other secondary brain injuries are often unrecognized without continuous EEG monitoring. There is increasing evidence that continuous EEG monitoring facilitates early identification and management of changes in brain function, and a recent consensus statement concludes that "each center should provide critical care continuous EEG at the highest level that local resources allow". Neonatal neuro-intensive care is a rapidly developing field with a focus on monitoring of the developing brain. Without continuous EEG monitoring, neonates with paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for many months, with inherent risks of side effects. Because paroxysmal events in neonates may or may not represent seizures, and electrographic seizures may have no discernable clinical correlate, this approach fails to adequately diagnose seizures and exposes neonates to possible harm, either by medication overuse for paroxysmal events that have no electrographic correlate, or by under-treatment of seizures without clinical manifestations. Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring method, using fewer numbers of electrodes and usually being interpreted by a neonatologist or trainee. This model has been implemented at the investigators NICU. However, a recent systematic review came to the conclusion that amplitude-integrated EEG has relatively low and variable sensitivity and specificity, and therefore should not be the mainstay for diagnosis and management of neonatal seizures. Continuous video EEG monitoring is recommended as the gold standard for critically ill neonates, but is a very expensive and resource-intense method. An approach combining both techniques in a standardized algorithm may provide improved patient care in a resource-restricted environment. The investigators are planning to test this hypothesis in a pilot project.
Read the detailed description
HYPOTHESIS
An algorithm combining conventional and amplitude-integrated EEG monitoring will increase specificity and sensitivity of seizure detection in critically ill high-risk neonates in a resource-restricted environment.
OBJECTIVES
- To describe the sensitivity and specificity of amplitude-integrated EEG (aEEG) relative to conventional EEG (cEEG) monitoring in high-risk critically ill neonates
- To evaluate the feasibility of an algorithm combining amplitude-integrated and conventional EEG monitoring in high-risk critically ill neonates
Long-term Objectives
The proposed pilot research project will provide fundamental information essential for designing a future larger scale study analyzing a standardized algorithm of combined continuous EEG monitoring for high-risk critically ill neonates at the investigators NICU, with the ultimate goal of preventing secondary brain injury in these patients.
Parents of potentially eligible patients will be approached by a study team member and will receive study information.
Consent will be attained after sufficient time to review the consent form and to ask questions.
This is a prospective study. We are aiming to enroll 20 neonates at high risk for seizures, consecutively.
Monitoring
Electrode positioning:
The aEEG and the cEEG consist of 3 to 5 and of 8 to 14 electrodes respectively.
Neonatal EEG application and set up will follow the international standard protocol in use at the investigators NICU.
The electrodes will not be replaced unless there is a signal interruption. A local skin lesions might occur, in very rare cases, when prolonged EEG ( over 2-3 days).
Monitoring protocol:
Neonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel, as soon as an EEG technician is available, which should usually be within less than 16 hours, in many cases within 1-4 hours.
Amplitude-integrated EEGs will be read and interpreted continuously, as currently standard of care at the investigators NICU. Conventional EEGs will be interpreted by a neurologist. During the review process, the neurology conventional EEG interpretation team will be blinded to the results of the amplitude-integrated EEG read by the neonatology team, and vice versa.
Electrographic seizure events or other clinically relevant findings (e.g. abnormalities of background activity) will be communicated to the NICU staff (in accordance with current practice).
EEG monitoring will be performed for as long as current NICU guidelines require.
Measures captured will include:
- Time and duration of seizures as per clinical observation
- Time and duration of seizure as per amplitude integrated EEG
- Time and duration of seizure as per conventional EEG
- Time and duration of background activity abnormality as per amplitude integrated EEG
- Time and duration of background activity abnormality as per conventional EEG
- Other relevant findings on amplitude integrated EEG (e.g. localization-related)
- Other relevant findings on conventional EEG (e.g. localization-related)
- Conditions
- Critically Ill
- Being tested
- EEG monitoring
- Keywords
- Critically ill, High risk neonates
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDevice
Neonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel.
| Study group | Role | What they receive |
|---|---|---|
| EEG monitoring | Other | Neonates will receive their aEEG monitoring as soon as the indication for monitoring is established, and cEEG electrodes will be applied in parallel, as soon as an EEG technician is available, which should usually be within less than 16 hours, in many cases within 1-4 hours. Receives: Device: EEG monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seizures detected
- Number of seizures detected via conventional, but not amplitude-integrated EEG
- Number of seizures detected via amplitude-integrated EEG that in fact were not seizures on interpretation via conventional EEG
Measured: Through study completion, an average of 3 days
Secondary outcomes (1)
Number of events providing treatment-relevant information
- Number of events where cEEG monitoring provide treatment-relevant information that would not have been available with aEEG monitoring alone
- Number of events where cEEG monitoring provide clinically relevant information that would not have been available with aEEG monitoring alone (e.g. abnormality of background activity, localization findings)
Measured: Through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start5 Jan 2017
- Primary completion22 Apr 2018
- Study completion22 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dror Mandel, MD, Principal investigator, Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925988
- Sponsor's protocol ID
- 0319-16-TLV-DM
- Status last verified
- Jun 2020
- First submitted
- 28 Sep 2016
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Amplitude-integrated and Conventional EEG Monitoring in High-risk Critically Ill Neonates: A Pilot Study
- ClinicalTrials.gov ID
- NCT02925988
- Acronym / sponsor ID
- 0319-16-TLV-DM
- Conditions
- Critically Ill
- Keywords
- Critically ill, High risk neonates
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 22 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 6 Oct 2016 (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.
Over the past decade, technical advances have improved the efficiency of continuous EEG recording and remote review, leading to a steep increase in the number of continuous EEGs performed, and to an emerging change in what is considered the standard of care with regards to brain monitoring. Critically ill patients are at high risk for CNS insults, which can result in permanent neurologic disability if untreated. Non-convulsive status epilepticus and other secondary brain injuries are often unrecognized without continuous EEG monitoring. There is increasing evidence that continuous EEG monitoring facilitates early identification and management of changes in brain function, and a recent consensus statement concludes that "each center should provide critical care continuous EEG at the highest level that local resources allow". Neonatal neuro-intensive care is a rapidly developing field with a focus on monitoring of the developing brain. Without continuous EEG monitoring, neonates with paroxysmal events that are suspicious for seizures are treated with phenobarbital, often for many months, with inherent risks of side effects. Because paroxysmal events in neonates may or may not represent seizures, and electrographic seizures may have no discernable clinical correlate, this approach fails to adequately diagnose seizures and exposes neonates to possible harm, either by medication overuse for paroxysmal events that have no electrographic correlate, or by under-treatment of seizures without clinical manifestations. Amplitude-integrated EEG technology is now increasingly used as a simplified monitoring method, using fewer numbers of electrodes and usually being interpreted by a neonatologist or trainee. This model has been implemented at the investigators NICU. However, a recent systematic review came to the conclusion that amplitude-integrated EEG has relatively low and variable sensitivity and specificity, and therefore should not be the mainstay for diagnosis and management of neonatal seizures. Continuous video EEG monitoring is recommended as the gold standard for critically ill neonates, but is a very expensive and resource-intense method. An approach combining both techniques in a standardized algorithm may provide improved patient care in a resource-restricted environment. The investigators are planning to test this hypothesis in a pilot project.
Detailed description
HYPOTHESIS
An algorithm combining conventional and amplitude-integrated EEG monitoring will increase specificity and sensitivity of seizure detection in critically ill high-risk neonates in a resource-restricted environment.
OBJECTIVES
- To describe the sensitivity and specificity of amplitude-integrated EEG (aEEG) relative to conventional EEG (cEEG) monitoring in high-risk critically ill neonates
- To evaluate the feasibility of an algorithm combining amplitude-integrated and conventional EEG monitoring in high-risk critically ill neonates
Long-term Objectives
The proposed pilot research project will provide fundamental information essential for designing a future larger scale study analyzing a standardized algorithm of combined continuous EEG monitoring for high-risk critically ill neonates at the investigators NICU, with the ultimate goal of preventing secondary brain injury in these patients.
Parents of potentially eligible patients will be approached by a study team member and will receive study information.
Consent will be attained after sufficient time to review the consent form and to ask questions.
This is a prospective study. We are aiming to enroll 20 neonates at high risk for seizures, consecutively.
Monitoring
Electrode positioning:
The aEEG and the cEEG consist of 3 to 5 and of 8 to 14 electrodes respectively.
Neonatal EEG application and set up will follow the international standard protocol in use at the investigators NICU.
The electrodes will not be replaced unless there is a signal interruption. A local skin lesions might occur, in very rare cases, when prolonged EEG ( over 2-3 days).
Monitoring protocol:
Neonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel, as soon as an EEG technician is available, which should usually be within less than 16 hours, in many cases within 1-4 hours.
Amplitude-integrated EEGs will be read and interpreted continuously, as currently standard of care at the investigators NICU. Conventional EEGs will be interpreted by a neurologist. During the review process, the neurology conventional EEG interpretation team will be blinded to the results of the amplitude-integrated EEG read by the neonatology team, and vice versa.
Electrographic seizure events or other clinically relevant findings (e.g. abnormalities of background activity) will be communicated to the NICU staff (in accordance with current practice).
EEG monitoring will be performed for as long as current NICU guidelines require.
Measures captured will include:
- Time and duration of seizures as per clinical observation
- Time and duration of seizure as per amplitude integrated EEG
- Time and duration of seizure as per conventional EEG
- Time and duration of background activity abnormality as per amplitude integrated EEG
- Time and duration of background activity abnormality as per conventional EEG
- Other relevant findings on amplitude integrated EEG (e.g. localization-related)
- Other relevant findings on conventional EEG (e.g. localization-related)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG monitoring | Other | Device: EEG monitoringNeonates will receive their aEEG monitoring as soon as the indication for monitoring is established, and cEEG electrodes will be applied in parallel, as soon as an EEG technician is available, which should usually be within less than 16 hours, in many cases within 1-4 hours. |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates admitted to our NICU
- Neonates identified to require aEEG monitoring as per current NICU guidelines (all neonates receiving therapeutic hypothermia as well as neonates with clinical events suggestive of seizures)
Key exclusion criteria (1 listed)
- Neonates not eligible for EEG monitoring (e.g. patients with extensive cephalhematoma or subgaleal hemorrhage, interfering with the application of electrodes)
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 monitoringNeonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel. | Device | EEG monitoring |
Primary outcome
Number of seizures detected
Time frame: Through study completion, an average of 3 days
1. Number of seizures detected via conventional, but not amplitude-integrated EEG 2. Number of seizures detected via amplitude-integrated EEG that in fact were not seizures on interpretation via conventional EEG
1 secondary outcome
Number of events providing treatment-relevant information
Time frame: Through study completion, an average of 3 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Dror Mandel, MD principal investigator
Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
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 in people with Critically Ill, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Jun 2020. 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 Israel. 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 was stopped early. Results are not available in the source record.
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?
Number of seizures detected (time frame: Through study completion, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2020.