Unintended Home Injuries in Under-5 ChildrenNCT05421039
Unintended Home Injuries in Under-5 Children in Sohag Governorate
An observational study of Unintended Home Injuries in Under-5 Children, run by Sohag University.
Trial summary
Child injuries are a major public health problem . Globally, unintended injury is one of the top 15 causes of death across all age groups of children aged؛ 0-19 years, In children under the age of five, the majority of injuries occur in the home. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Unintended Home Injuries in Under-5 Children
- What is being tested?
- Exposure to unintended injuries
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 30 Apr 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 2 months to 5 years
- All sexes
- Child
Study population: The study targeted under-5 children with their caregivers
Who may be able to join
- The study will be conducted through personal interview with caregivers of under-5 children who accept to participate in it .
Who cannot join
- Caregivers who refuse to participate in the study and caregivers of children who experienced intended home injuries will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Child injuries are a major public health problem . Globally, unintended injury is one of the top 15 causes of death across all age groups of children aged؛ 0-19 years, In children under the age of five, the majority of injuries occur in the home.
Injuries is a health concern in every country around the world, affecting both developed and developing countries, causing over 5.8 million deaths per year or 15,000 deaths per day .
Read more
A WHO surveillance study conducted in four developing countries showed that Egypt had a prevalence of 32 % of childhood injuries which was the highest one .
The home is the place where children spend most of their time, the home environment is the most common place for childhood injuries
Read the detailed description
There is a lack of studies related to unintended home injuries in under-5 children in Sohag Governorate , unintended home injuries may result in temporary or permanent disability and requires medical attention and continuous care .
A limited number of child home injuries lead to hospitalization , so hospital based studies may ignore small scale injuries which couldn't be registered.
Unintended home injuries may influence health, education, and family economy of the affected children.
Unintended home injuries is one of the preventable causes of child morbidity and mortality , so we should know the prevalence and factors predisposing to it .
The aim of the study is to decrease morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate by assessing prevalence and epidemiology of unintended home injuries in under-5 children in Sohag Governorate ,measuring extent of morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate , determining factors predisposing to unintended home injuries in under-5 children in Sohag Governorate .
- Being tested
- Exposure to unintended injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to unintended injuriesBehavioural
After taking a verbal consent , an explanation of the study will be given to the caregivers
, those who fulfill the inclusion criteria will be enrolled in the study. Personal interviews by the researcher will be made with individuals or groups (2-4 persons) , participants will be chosen by means of systematic random sampling among visitors ؛ every 3rd or 5th child according to density and flow of attendance .
the investigator will fill the questionnaire through personal interview with the caregivers
| Study group | Role | What they receive |
|---|---|---|
| Group (1) | With the exposure Receives: Behavioral: Exposure to unintended injuries | |
| Group (2) | Without the exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unintended Home Injuries in Under-5 Children in Sohag Governorate
Assess prevalence and epidemiology of unintended home injuries in under-5 children in Sohag Governorate
Measured: 2 months
Unintended Home Injuries in Under-5 Children in Sohag Governorate
Measure extent of morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate .
Measured: 2 months
Unintended Home Injuries in Under-5 Children in Sohag Governorate
Determine factors predisposing to unintended home injuries in under-5 children in Sohag Governorate .
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unintended Home Injuries in Under-5 ChildrenStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Gamal Salem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421039
- Sponsor's protocol ID
- Soh-med-22-06-02
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unintended Home Injuries in Under-5 Children in Sohag Governorate
- ClinicalTrials.gov ID
- NCT05421039
- Acronym / sponsor ID
- Soh-med-22-06-02
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 16 Jun 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.
Child injuries are a major public health problem . Globally, unintended injury is one of the top 15 causes of death across all age groups of children aged؛ 0-19 years, In children under the age of five, the majority of injuries occur in the home.
Injuries is a health concern in every country around the world, affecting both developed and developing countries, causing over 5.8 million deaths per year or 15,000 deaths per day .
A WHO surveillance study conducted in four developing countries showed that Egypt had a prevalence of 32 % of childhood injuries which was the highest one .
The home is the place where children spend most of their time, the home environment is the most common place for childhood injuries
Detailed description
There is a lack of studies related to unintended home injuries in under-5 children in Sohag Governorate , unintended home injuries may result in temporary or permanent disability and requires medical attention and continuous care .
A limited number of child home injuries lead to hospitalization , so hospital based studies may ignore small scale injuries which couldn't be registered.
Unintended home injuries may influence health, education, and family economy of the affected children.
Unintended home injuries is one of the preventable causes of child morbidity and mortality , so we should know the prevalence and factors predisposing to it .
The aim of the study is to decrease morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate by assessing prevalence and epidemiology of unintended home injuries in under-5 children in Sohag Governorate ,measuring extent of morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate , determining factors predisposing to unintended home injuries in under-5 children in Sohag Governorate .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1) | – | Behavioral: Exposure to unintended injuriesWith the exposure |
| Group (2) | – | –Without the exposure |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- The study targeted under-5 children with their caregivers
Key inclusion criteria (1 listed)
- The study will be conducted through personal interview with caregivers of under-5 children who accept to participate in it .
Key exclusion criteria (1 listed)
- Caregivers who refuse to participate in the study and caregivers of children who experienced intended home injuries will be excluded from the study.
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 |
|---|---|---|
| Exposure to unintended injuriesAfter taking a verbal consent , an explanation of the study will be given to the caregivers , those who fulfill the inclusion criteria will be enrolled in the study. Personal interviews by the researcher will be made with individuals or groups (2-4 persons) , participants will be chosen by means of systematic random sampling among visitors ؛ every 3rd or 5th child according to density and flow of attendance . the investigator will fill the questionnaire through personal interview with the caregivers | Behavioural | Group (1) |
Primary outcome
Unintended Home Injuries in Under-5 Children in Sohag Governorate
Time frame: 2 months
Assess prevalence and epidemiology of unintended home injuries in under-5 children in Sohag Governorate
Unintended Home Injuries in Under-5 Children in Sohag Governorate
Time frame: 2 months
Measure extent of morbidities and mortalities associated with unintended home injuries in under-5 children in Sohag Governorate .
Unintended Home Injuries in Under-5 Children in Sohag Governorate
Time frame: 2 months
Determine factors predisposing to unintended home injuries in under-5 children in Sohag Governorate .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Unintended Home Injuries in Under-5 Children, run by Sohag 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 16 Jun 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?
Contact Alaa Salem (01028293936, alaagamal@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unintended Home Injuries in Under-5 Children in Sohag Governorate (time frame: 2 months). The study lists 3 primary outcomes in all. 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 16 Jun 2022.