Neonatal SeizureNCT05257889
Neonatal Seizures in NICU of Assuit University Children's Hospital
An observational study of Neonatal Seizure, run by Assiut University.
Trial summary
A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Neonatal Seizure
- What is being tested?
- blood and CSF studies + neuroimaging studies
- How many people
- 554 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- Neonates with multiple congenital anomalies (other than CNS anomalies)
About this study
Official title: 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.
Read the 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
- Conditions
- Neonatal Seizure
- Being tested
- blood and CSF studies + neuroimaging studies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and CSF studies + neuroimaging studiesDiagnostic test
blood and CSF studies + neuroimaging studies
| Study group | Role | What they receive |
|---|---|---|
| neonatal seizures cases | Cases of neonatal seizures Receives: Diagnostic Test: blood and CSF studies + neuroimaging studies | |
| seizure-free neonates | cases that are seizure free Receives: Diagnostic Test: blood and CSF studies + neuroimaging studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
number of patients with controlled seizures during hospital admission period
Short term outcomes of clinical seizures (if seizures could be controlled during hospital admission period or not)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study startJul 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal SeizureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Salama, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257889
- Sponsor's protocol ID
- 17101539
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Overview on Neonatal Seizures in Neonatal Intensive Care Unit of Assuit University Children's Hospital, a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05257889
- Acronym / sponsor ID
- 17101539
- Conditions
- Neonatal Seizure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neonatal seizures cases | – | Diagnostic Test: blood and CSF studies + neuroimaging studiesCases of neonatal seizures |
| seizure-free neonates | – | Diagnostic Test: blood and CSF studies + neuroimaging studiescases that are seizure free |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Neonates with multiple congenital anomalies (other than CNS anomalies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and CSF studies + neuroimaging studiesblood and CSF studies + neuroimaging studies | Diagnostic test | neonatal seizures cases, seizure-free neonates |
Primary outcome
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 secondary outcome
number of patients with controlled seizures during hospital admission period
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Seizure, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.