Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03588858
Status:
UNKNOWN
Last Update Posted:
2018-07-17
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Child Labour at Al-Sadat Neighborhood, Assiut City
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-15', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-07-15', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pulmonary function tests', 'timeFrame': 'Baseline', 'description': 'by using spirometry device'}], 'primaryOutcomes': [{'measure': 'Hemoglobin level measurements by using Mission Hb Hemoglobin Meter', 'timeFrame': 'Baseline', 'description': 'gm/dl'}], 'secondaryOutcomes': [{'measure': 'measurements (weight by weighing scale and height by height scale)', 'timeFrame': 'Baseline', 'description': 'weight in kilograms and height in centimeters will be combined to report Body Mass Index in kg/m\\^2).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Work-Related Condition']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'ILO. What is child labour, International Labour Organization'}]}, 'descriptionModule': {'briefSummary': 'General objective: To promote proper health status of working children in Assiut city.\n\nSpecific objectives:\n\n1. To describe the socio-demographic characteristics of children working in car repair workshops in Al-Sadat area of Assiut city.\n2. To describe the work environment.\n3. To identify work related injuries and diseases among those working children.', 'detailedDescription': 'Study population: Children working in car repair workshops in Al-Sadat area of Assiut city. Male children aged from 5 to 17 years will be included in this study.\n\nInstrument: Data collection will be performed by using structured interview questionnaires. The questionnaire used for data collection will cover the following modules:\n\n* Module (1): Socio-demographic characteristics (for example: age, family size, family residence, education and occupation of the parents, number of sibling, family income, etc).\n* Module (2) :Occupational history : (Housing conditions and occupational features; age at the beginning of working, duration of working, working hours/day, weekend vacation, weekly income, causes of child work, nature of work, work hazards, type of exposure, health habits and practices such as smoking in addition to causes of school dropout…. etc)\n* Module (3): Presence of work related injuries and diseases by history and observation.\n* Module (4): Food frequency questionnaires (FFQ) during the past week: It will show the diet of working children if have a healthy and nutritious pattern or not.\n* Module (5): Mental health screening: Self-reporting questionnaire 20 questions for assessment of mental health status of children.\n* After collection of data the children will subjected to the following investigations:\n\nHB level measurements - anthropometric measurements (weight and height) - pulmonary function tests (spirometry) and hearing level assessment by audiometry will be done only for children more than 12 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted at the workshops of car repair in Al-Sadat area of Assiut city. The number of these workshops is 130 and the number of working children in these workshops about 150 child.', 'genderDescription': 'Male children aged from 5 to 17 years will be included in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children working in car repair workshops in Al-Sadat area of Assiut city. Male children aged from 5 to 17 years\n\nExclusion Criteria:\n\n* Children outside the age range (below 5 years),\n* Female children'}, 'identificationModule': {'nctId': 'NCT03588858', 'briefTitle': 'Child Labour at Al-Sadat Neighborhood, Assiut City', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Child Labour at Al-Sadat Neighborhood, Assiut City', 'orgStudyIdInfo': {'id': 'Child labour at Assiut city'}}, 'armsInterventionsModule': {'interventions': [{'name': 'structured interview questionnaires', 'type': 'OTHER', 'description': '* Module (1): Socio-demographic characteristics\n* Module (2) :Occupational history\n* Module (3): Presence of work related injuries and diseases by history and observation.\n* Module (4): Food frequency questionnaires (FFQ) during the past week.\n* Module (5): Mental health screening: Self-reporting questionnaire 20 questions for assessment of mental health status of children.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hisham Ali', 'role': 'CONTACT', 'email': 'dr_his_1980@hotmail.com', 'phone': '+201003881661'}], 'overallOfficials': [{'name': 'Sabra Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hisham Ragab Ali', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician at Public Health and Community Medicine department', 'investigatorFullName': 'Hisham Ragab Ali', 'investigatorAffiliation': 'Assiut University'}}}}