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Clinical Profile And Outcome Of Neonatal Convulsions Among Newborns Admitted To The Neonatal Intensive Care Unit At Assiut University Children's Hospital: A Prospective Cohort Study
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Start Date
December 1, 2025
Primary Completion Date
December 1, 2026
Completion Date
January 1, 2027
Last Updated
December 10, 2025
139
ESTIMATED participants
Management of Neonatal Convulsions
OTHER
Lead Sponsor
Assiut University
NCT05077904
NCT05667142
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07234695