An observational study in Neonatal Convulsions, Newborn Seizure Disorders and Seizures, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Assiut University · Observational
Neonatal convulsions are seizures that occur during the first 28 days of a newborn's life. They are considered a medical emergency and often indicate an underlying problem in the brain, such as lack of oxygen at birth, infections, metabolic disturbances, or structural abnormalities. Many seizures in newborns are subtle and difficult to detect without careful clinical assessment.
This study aims to determine how often neonatal convulsions occur among newborns admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children Hospital. It will describe how affected newborns present clinically, identify the main causes, and evaluate the early outcomes during hospitalization.
The study is designed as a prospective cohort study. Newborns aged 0-30 days who are diagnosed with neonatal convulsions will be enrolled and followed throughout their stay in the NICU. Each patient will undergo full clinical evaluation and standard laboratory and imaging investigations, including blood tests, neuroimaging, and other tests as clinically indicated.
The findings of this study will provide updated local data on the incidence, causes, and outcomes of neonatal convulsions in our region. This information may help improve early diagnosis, guide appropriate treatment, and enhance the quality of neonatal care.
Neonatal convulsions represent one of the most important neurological emergencies in early life and are strongly associated with underlying brain dysfunction. In many cases, the clinical manifestations are subtle, making diagnosis challenging without careful observation and appropriate diagnostic tools. Early recognition of neonatal seizures and identification of their etiologies play essential roles in preventing long-term neurological complications.
This prospective cohort study is designed to investigate the clinical profile and outcomes of neonatal convulsions among newborns admitted to the Neonatal Intensive Care Unit at Assiut University Children Hospital. The study will include newborns aged 0 to 30 days, of both sexes, who are clinically diagnosed with neonatal convulsions. Exclusion criteria include infants older than 30 days or those with movement disorders that mimic seizures, such as jitteriness, benign neonatal sleep myoclonus, hyperekplexia, motor automatisms, or Sandifer syndrome.
After obtaining informed consent from parents or caregivers, enrolled neonates will undergo a comprehensive assessment that includes detailed maternal and perinatal history, physical examination, neurological evaluation, and documentation of seizure semiology. Laboratory investigations include complete blood count, renal and liver function tests, serum electrolytes, blood glucose, metabolic screening when indicated, and infection workup. Neuroimaging such as cranial ultrasound, CT scan, or MRI will be performed based on clinical indications. Additional investigations such as EEG may be used as available.
The primary outcome is to determine the rate of neonatal convulsions among NICU admissions. Secondary outcomes include identification of the most common etiologies, description of clinical patterns, response to treatment, and early in-hospital outcomes such as seizure control, complications, and duration of NICU stay.
Data will be analyzed using standard statistical methods to generate descriptive and analytic comparisons. Findings from this study are expected to fill important knowledge gaps in the local epidemiology of neonatal convulsions and provide evidence to improve diagnostic strategies, early intervention, and quality of neonatal care.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's planned enrollment of 139 is close to the median of 150 across 235 observational studies indexed under Seizures.
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The study population includes neonates aged 0 to 30 days admitted to the Neonatal Intensive Care Unit (NICU) at Assiut University Children's Hospital who are diagnosed with neonatal convulsions. Both full-term and preterm infants of either sex will be included. Neonates with conditions mimicking seizures (e.g., jitteriness, benign neonatal sleep myoclonus, motor automatisms, hyperekplexia, Sandifer syndrome) will be excluded. The target population is expected to be representative of neonates admitted to the NICU with convulsions during the study period from March 2024 to August 2025.
Exclusion Criteria:
This cohort includes neonates aged 0-30 days who are admitted to the Neonatal Intensive Care Unit at Assiut University Children's Hospital and diagnosed with neonatal convulsions. Participants will undergo clinical evaluation, laboratory investigations, neuroimaging, and follow-up to assess seizure characteristics, underlying etiologies, management, and outcomes. No interventions will be assigned; only observational data will be collected.
Other: Management of Neonatal Convulsions
This intervention involves the clinical management of neonatal convulsions in newborns aged 0-30 days admitted to the NICU. Management includes prompt identification of seizure activity through clinical evaluation and EEG confirmation, followed by appropriate treatment using anticonvulsant medications such as phenobarbital. Supportive care includes monitoring of vital signs, glucose, and electrolytes, and performing necessary investigations like abdominal ultrasound, echocardiography, and brain imaging (MRI/CT) to identify underlying causes. The intervention aims to control seizures, minimize neurological complications, and improve short-term and long-term outcomes in affected neonates.
Rate of neonatal convulsions in newborns admitted to the NICU
The proportion of neonates diagnosed with convulsions confirmed clinically and by EEG during hospitalization in the neonatal intensive care unit.
Time frame: During NICU stay (up to 30 days of age)
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Assiut University