NCT06106425

Brief Summary

Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 24, 2023

Last Update Submit

October 24, 2023

Conditions

EEC

Outcome Measures

Primary Outcomes (1)

  • evaluate the role of EEG as a diagnostic as well as prognostic tool in neonatal convulsions.

    Diagnostic and prognostic criteria of EEG in neonatal convulsions at Assiut University Children Hospital

    Baseline

Interventions

EEGDIAGNOSTIC_TEST

diagnostic tool

Eligibility Criteria

AgeUp to 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

95 cases

You may qualify if:

  • \- Neonates (\< 28 days) presenting with a convulsive attack in the form of a paroxysmal alteration in motor function.

You may not qualify if:

  • Non- seizure events as Tremors, Jitteriness or Clonus or Neonatal Apnea
  • Normal Newborn Behaviour such as stretching, coughing or gagging,
  • Physiological Benign Neonatal Myoclonus during sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12.

    PMID: 28711233BACKGROUND

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 24, 2023

First Posted

October 30, 2023

Study Start

October 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

October 30, 2023

Record last verified: 2023-10