EECNCT06106425
Diagnostic and Prognostic Criteria of EEG in Neonatal Convulsions at Assiut University Children Hospital
An observational study of EEC, run by Assiut University.
Trial summary
Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- EEC
- What is being tested?
- EEG
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2024
- Phase
- Observational
- 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 Up to 28 days
- All sexes
- Child
Study population: 95 cases
Who may be able to join
- - Neonates (< 28 days) presenting with a convulsive attack in the form of a paroxysmal alteration in motor function.
Who cannot join
- Non- seizure events as Tremors, Jitteriness or Clonus or Neonatal Apnea
- Normal Newborn Behaviour such as stretching, coughing or gagging,
- Physiological Benign Neonatal Myoclonus during sleep
About this study
Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital
Read the detailed description
The electroencephalogram (EEG) was invented almost 100 years ago and is still a method of choice for many research questions. It is a graphic representation of the difference in voltage between two different cerebral locations plotted over time. The scalp EEG signal generated by cerebral neurons is modified by electrical conductive properties of the tissues between the electrical source and the recording electrode on the scalp, conductive properties of the electrode itself, as well as the orientation of the cortical generator to the recording electrode, (Olejniczak, P et al 2006).
EEG is best used to study the response of the brain to events in the environment or to internal changes during a seizure. EEG is one of the main tools for obtaining electrophysiological information about cerebral function, (Fowle AJ, Binnie CD et al 2000).
Research using neonatal electroencephalography (EEG) has been limited by a lack of a standardized classification system and interpretation terminology.
Electroencephalography (EEG) is an important tool to assess brain function in neonates, for whom clinical observation alone is often insufficient to accurately evaluate cerebral function. EEG is used to assess the severity of brain dysfunction in neonates with known or suspected brain injury; abnormal EEG background features may serve as indicators of unfavorable long-term prognosis, (Wusthoff CJ, Sullivan J et al 2017).
Seizures are the most frequent neurological event in newborns and clinical data suggest that etiology is the dominant factor in long term outcome. However, there are consistent background EEG abnormalities associated to neonatal seizures that are usually related to unfavorable outcome. For example, the burst - suppression pattern may appear related to many neonatal neurological disorders and is associated with early and refractory neonatal seizures, (Nunes ML, Giraldes MM et al 2005).
Also, a normal EEG in a term newborn with hypoxic ischemic encephalopathy (HIE) is associated with good neurological outcome. (Jose A, Matthai J et al 2013).
The chances of survival of preterm infants have increased markedly during recent decades. However, despite this improved survival prognosis, several studies have pointed towards the poor psychomotor outcome of these infants. For example, periventricular leukomalacia is the most common type of hypoxic-ischaemic brain damage causing poor psychomotor development in usually very preterm infants. Diagnostic procedures for detecting brain damage in newborn infants are of two types: bedside and non-bedside techniques. The neuro-developmental outcome is correlated with the number of positive Rolandic sharp waves seen on the EEG recording,
- Conditions
- EEC
- Being tested
- EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
diagnostic tool
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the role of EEG as a diagnostic as well as prognostic tool in neonatal convulsions.
Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
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 EECStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mahrous Mohammedein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106425
- Sponsor's protocol ID
- EEG in neonatal convulsions
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12.
PubMed 28711233
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Criteria of EEG in Neonatal Convulsions at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06106425
- Acronym / sponsor ID
- EEG in neonatal convulsions
- Conditions
- EEC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 30 Oct 2023 (actual)
- 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.
Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital
Detailed description
The electroencephalogram (EEG) was invented almost 100 years ago and is still a method of choice for many research questions. It is a graphic representation of the difference in voltage between two different cerebral locations plotted over time. The scalp EEG signal generated by cerebral neurons is modified by electrical conductive properties of the tissues between the electrical source and the recording electrode on the scalp, conductive properties of the electrode itself, as well as the orientation of the cortical generator to the recording electrode, (Olejniczak, P et al 2006).
EEG is best used to study the response of the brain to events in the environment or to internal changes during a seizure. EEG is one of the main tools for obtaining electrophysiological information about cerebral function, (Fowle AJ, Binnie CD et al 2000).
Research using neonatal electroencephalography (EEG) has been limited by a lack of a standardized classification system and interpretation terminology.
Electroencephalography (EEG) is an important tool to assess brain function in neonates, for whom clinical observation alone is often insufficient to accurately evaluate cerebral function. EEG is used to assess the severity of brain dysfunction in neonates with known or suspected brain injury; abnormal EEG background features may serve as indicators of unfavorable long-term prognosis, (Wusthoff CJ, Sullivan J et al 2017).
Seizures are the most frequent neurological event in newborns and clinical data suggest that etiology is the dominant factor in long term outcome. However, there are consistent background EEG abnormalities associated to neonatal seizures that are usually related to unfavorable outcome. For example, the burst - suppression pattern may appear related to many neonatal neurological disorders and is associated with early and refractory neonatal seizures, (Nunes ML, Giraldes MM et al 2005).
Also, a normal EEG in a term newborn with hypoxic ischemic encephalopathy (HIE) is associated with good neurological outcome. (Jose A, Matthai J et al 2013).
The chances of survival of preterm infants have increased markedly during recent decades. However, despite this improved survival prognosis, several studies have pointed towards the poor psychomotor outcome of these infants. For example, periventricular leukomalacia is the most common type of hypoxic-ischaemic brain damage causing poor psychomotor development in usually very preterm infants. Diagnostic procedures for detecting brain damage in newborn infants are of two types: bedside and non-bedside techniques. The neuro-developmental outcome is correlated with the number of positive Rolandic sharp waves seen on the EEG recording,
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- 95 cases
Key inclusion criteria (1 listed)
- - Neonates (< 28 days) presenting with a convulsive attack in the form of a paroxysmal alteration in motor function.
Key exclusion criteria (3 listed)
- Non- seizure events as Tremors, Jitteriness or Clonus or Neonatal Apnea
- Normal Newborn Behaviour such as stretching, coughing or gagging,
- Physiological Benign Neonatal Myoclonus during sleep
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 |
|---|---|---|
| EEGdiagnostic tool | Diagnostic test | – |
Primary outcome
evaluate the role of EEG as a diagnostic as well as prognostic tool in neonatal convulsions.
Time frame: Baseline
Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Background: PubMed 28711233Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of EEC, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
evaluate the role of EEG as a diagnostic as well as prognostic tool in neonatal convulsions. (time frame: Baseline). 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 NCT06106425, 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 30 Oct 2023.