Neonatal Seizures in NICU of Assuit University Children's Hospital

February 24, 2022 updated by: Ahmed Mohamed Salama, Assiut University

An Overview on Neonatal Seizures in Neonatal Intensive Care Unit of Assuit University Children's Hospital, a Cross Sectional Study

A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

An Overview on neonatal seizures in neonatal intensive care unit of Assuit University Children's hospital , a cross sectional study. The aim of this study is to evaluate the clinical seizures during the neonatal period and its prevalence

Study Type

Observational

Enrollment (Anticipated)

554

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

1 day to 1 month (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ALL neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of Assiut University Children's hospital

Description

Inclusion Criteria:

  • ALL neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of Assiut University Children's hospital during the period of the study will be included

Exclusion Criteria:

  • Neonates with multiple congenital anomalies (other than CNS anomalies)

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 seizures cases
Cases of neonatal seizures
Diagnostic test: blood and CSF studies + neuroimaging studies
blood and CSF studies + neuroimaging studies
seizure-free neonates
cases that are seizure free
Diagnostic test: blood and CSF studies + neuroimaging studies
blood and CSF studies + neuroimaging studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital
Time Frame: 1 year
prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital during period of study
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients with controlled seizures during hospital admission period
Time Frame: 1 year
Short term outcomes of clinical seizures (if seizures could be controlled during hospital admission period or not)
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

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 (ANTICIPATED)

July 1, 2022

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (ACTUAL)

February 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17101539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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