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.: PACTR202307508536985 Date of Approval: 26/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title passive smoking and executive functions in children
Official scientific title Impact of passive smoking on executive and pulmonary functions in school aged children
Brief summary describing the background and objectives of the trial Passive smoking is the leading preventable cause of many issues in children which has also been related to a wide range of physical, respiratory, and mental health constraints in children. This study aims to investigate the effect of passive smoking on executive and pulmonary functions in school-aged children. A cross-sectional study will carry out on school-aged children , their ages will range between 8–12 years.executive functions were evaluated using the Tower of Hanoi, Eriksen flanker test, Stroop colored word test, Trail-making test part A, and Trail-making test part B. Pulmonary functions included (forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow rate (PEFR), and FEV1/FVC were measured by the spirometer. There is now emerging evidence that intelligence and mental health involved in the inter-relationship between smoking and neurodevelopment and PS negatively impact behavior, attention, physical function, and cognition. A link between PS with cognitive and behavioral problems among children such as attention problems, cognitive and intellectual deficits were reported. As neurobehavioral tests were described as reliable and valid indicators of brain function and dysfunction and can discriminate group differences caused by chemical exposure so it can reflect early and subclinical effects of PS on childrenIdentification of the risks of passive smoking on children's mental and physical health is crucial because exposure to passive smoking among children is widespread throughout the world and continues to be a significant public health problem. It is recommended to increase awareness of society to protect the emerging generation from the hazards of passive smoking and prevent it in every possible way for the future of our home as passive smoking can affect the functions of the brain and lungs and lead to motor and mental problems so the purpose of this study is to investigate the effect of passive smoking
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/06/2023
Actual trial start date 01/06/2023
Anticipated date of last follow up 01/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 240
Recruitment status Not yet recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group passive smoking heavy smoking (more than 25 cigarettes per day) moderate smoking (15-25 cigarettes per day) for at least 9 years of passive smoking passive smoking 120
Control Group non passive smoking children not applicable not applicable healthy controls, non passive smoking 120 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
their ages will be ranged from 8 to 12 years old the passive smoking children one or both parents were smoker not less than 9 years children will be excluded if they have any of the following: history of cardio respiratory disease respiratory disorders motor developmental delay Child: 6 Year-12 Year 8 Year(s) 12 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 13/11/2022 Research Ethical Committee Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayat Street - Bein El Sarayat - Dokki - Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome executive functions not applicable
Secondary Outcome pulmonary functions not applicable
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Garfis primary school Aledara alzeraia street, Garfis village, senoris destrict. Alfayoum 63773 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Sayed Mahmoud Tolba Aledara alzeraia street, alfayoum governorate Alfayoum 63773 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded aledara alzeraayia street, alfayoum governorate alfayoum 63773 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Sayed tolba Ahmedsayedmahmoud1992@hotmail.com +201095234799 aledara alzeraia street, al fayoum governorate
City Postal code Country Position/Affiliation
alfayoum governorate 63773 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Ahmed Sayed tolba Ahmedsayedmahmoud1992@hotmail.com +201095234799 aledara alzerayia street
City Postal code Country Position/Affiliation
alfayoum 63773 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Sayed Tolba ahmedsayedmahmoud1992@hotmail.com +201095234799 aledara alzerayia
City Postal code Country Position/Affiliation
alfayoum 63773 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data will be available with the removal of any details from the personally identifiable information that the information refers to.(de-identified individual trial participant data) Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 12 months after article publication and the data will be made accessible for up to 24 months. data will be available upon request from the author
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information