Clinical Profile And Outcomes Of Neonatal Convulsions In The Neonatal Intensive Care Unit At Assiut University Children's Hospital

November 28, 2025 updated by: zeinab ahmed abdel sabour, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Children aged between 0 to 30day.
  • Children diagnosed with neonatal seizures
  • All newborn fullterm,preterm.males and females with neonatal convulsions.

Exclusion Criteria:

  • Children above age of 30 day and those with mimic condition as
  • jitteriness, benign neonatal sleep myoclonus, motor automatisms,
  • hyperekplexia, and Sandifer syndrome..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neonatal Convulsions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of neonatal convulsions in newborns admitted to the NICU
Time Frame: During NICU stay (up to 30 days of age)
The proportion of neonates diagnosed with convulsions confirmed clinically and by EEG during hospitalization in the neonatal intensive care unit.
During NICU stay (up to 30 days of age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC-ASSIUT-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Seizures

Clinical Trials on Management of Neonatal Convulsions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe