Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801002991130 Date of Approval: 20/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title oxidative stress and attention in epilepsy
Official scientific title oxidative stress and attention in children with idiopathic epilepsy
Brief summary describing the background and objectives of the trial Children with epilepsy have impaired cognitive function including attention , memory and executive function. Oxidation stress has linked to cognitive impairment in elderly, however its role in cognitive impairment in children with epilepsy is not fully explored. The aim of the current study is to explore the association between serum level of malonaldhyde as oxidation stress marker and selective attention assessed by auditory event related potential P300 event related potential in a group of children with idiopathic epilepsy.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied epilepsy,Genetic Diseases,Mental and Behavioural Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 20/09/2017
Actual trial start date 20/09/2017
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date 30/01/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 58
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group measure serum level of malonaldhyde measure serum level of malonaldhyde using ELISA kits 28
Experimental Group auditory P300 event related potential auditory P300 event related potential latency and amplitute 28
Control Group measure serum level of malonaldhyde measure serum level of malonaldhyde using ELISA kits 30
Control Group auditory P300 event related potential auditory P300 event related potential latency and amplitute 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
case group: Children with idiopathic epilepsy Aged 6-15 years control group: healthy age and sex matched children Children with any acute or chronic medical illness Children with mental retardation children with hearing impairment children with any concomitant psychological disorders Children with developmental delay Children with physical disabilities children received any medications affecting cognitive function as antihistamines control group: fullfil the same exclusion criteria and did not have any history of neurological disorders, seizures or family history of epilepsy 6 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/11/2017 ethics committee of Egyptian national research center
Ethics Committee Address
Street address City Postal code Country
Doki Giza 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess the association between malonaldhyde level as marker of oxidative stress and selective attention assessed by p300 auditory event related potential in children with idiopathic epilepsy at the end of enrollment
Secondary Outcome assess the association between clinical characterestics of epilepsy and the serum level of malonaldhyde oxidative marker and auditory event related potential at the end of enrollment
Secondary Outcome assess the impact of proper siezure control on both oxidative stress and selective attention at the end of enrollment
Primary Outcome assess the association between clinical characterestics of epilepsy and the serum level of malonaldhyde oxidative marker and auditory event related potential at the end of enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alzahraa University hospital, Faculty of medicine for girls, Al-Azhar university abassia cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund Obor city Qalubia 11828 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Research Center, Giza, Egypt. Doki Giza 12622 Egypt Charities/Societies/Foundation
Primary Sponsor Faculty of Medicine (for girls), Al-Azhar University, Cairo, Egypt Nasr city cairo 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Marwa Elhady 131 mahalia 5, 1st unite obor city Qalubia 11828 Egypt
Eman R Youness tahrer street, Doki, cairo Giza 12622 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Elhady marwaelhady93@yahoo.com 01120977670 Faculty of medicine for girls . Al-Azhar University
City Postal code Country Position/Affiliation
cairo 11759 Egypt lecturer of pediatrics
Role Name Email Phone Street address
Public Enquiries Marwa Elhady marwaelhady93@yahoo.com 01120977670 Faculty of medicine for girls . Al-Azhar University
City Postal code Country Position/Affiliation
cairo 11759 Egypt lecturer of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Marwa Elhady marwaelhady93@yahoo.com 01120977670 Faculty of medicine for girls . Al-Azhar University
City Postal code Country Position/Affiliation
cairo 11759 Egypt lecturer of pediatrics
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information