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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06106425
Other study ID # EEG in neonatal convulsions
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date October 2024

Study information

Verified date October 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital


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,


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: - - Neonates (< 28 days) presenting with a convulsive attack in the form of a paroxysmal alteration in motor function. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
EEG
diagnostic tool

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
See also
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