NCT05257889

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

February 7, 2022

Last Update Submit

February 24, 2022

Conditions

Neonatal Seizure

Outcome Measures

Primary Outcomes (1)

  • prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital

    prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital during period of study

    1 year

Secondary Outcomes (1)

  • number of patients with controlled seizures during hospital admission period

    1 year

Study Arms (2)

neonatal seizures cases

Cases of neonatal seizures

Diagnostic Test: blood and CSF studies + neuroimaging studies

seizure-free neonates

cases that are seizure free

Diagnostic Test: blood and CSF studies + neuroimaging studies

Interventions

blood and CSF studies + neuroimaging studiesDIAGNOSTIC_TEST

blood and CSF studies + neuroimaging studies

neonatal seizures casesseizure-free neonates

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

* CBC * Serum electrolytes (Serum Glucose, Serum Calcium , Serum Magnesium ) * Liver function tests * Blood urea and Serum Creatinine * Blood gases * CSF only (in suspected cases of CNS infections) * Serum ammonia and lactate levels for neonates suspected to have inborn errors of metabolism (extended metabolic screen if possible) * TORCH screening

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 25, 2022

Study Start

July 1, 2022

Primary Completion

August 1, 2023

Study Completion

October 1, 2023

Last Updated

February 25, 2022

Record last verified: 2022-02