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Determinants of Mortality and Severe Dehydration Among Hospitalized Children with Acute Diarrhea

ETH-20260308-0137 تاريخ التقديم: Mar 08, 2026 / Submitted: Mar 08, 2026
قيمة الرسوم / Payment Amount
21,000.00 SDG
نوع البحث / Research Type
ورقة علمية / Research Paper
فترة الدراسة / Study Period
Mar 17, 2026 - May 06, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20260308-0137
رقم الطلب
Request Number
ETH-20260308-0137
تاريخ تقديم الطلب
Date of Submission
2026-03-08

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Thoraya Salah Murtada Sidahmed
2. الجهة التي ينتمي إليها
Affiliation Type
جامعة / University: Alzaiem Alazhary University - Faculty of Medicine
Alzaiem Alazhary University - Faculty of Medicine
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
thorayagzzar@gmail.com
5. رقم الهاتف
Phone Number
-
المشرف / Supervisor
الاسم الكامل / Full Name
-
البريد الإلكتروني / Email
-
الوظيفة / اللقب العلمي / Job Title
-
رقم الهاتف / Phone
-
القسم / المؤسسة / Department
-

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Determinants of Mortality and Severe Dehydration Among Hospitalized Children with Acute Diarrhea
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☐بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☑ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☐أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
1. Introduction Diarrheal diseases remain one of the leading causes of illness and death among children under five years of age in many low-income countries. Children in resource-limited settings frequently present with complications such as dehydration, malnutrition, and electrolyte disturbances, which significantly increase the risk of mortality. Although oral rehydration therapy and standardized treatment guidelines have substantially reduced deaths globally, diarrhea continues to pose a major health burden in Sudan. Several contextual factors contribute to this persistent burden. Limited access to clean water, inadequate sanitation, poor nutritional status, and low vaccination coverage increase children’s vulnerability to severe diarrheal illness. In addition, delayed healthcare seeking behavior and socioeconomic factors such as maternal education may influence disease severity and treatment outcomes. Northern State in Sudan faces additional healthcare challenges related to infrastructure limitations and disparities in preventive healthcare services. Children admitted to hospitals with acute diarrhea often present with advanced dehydration or underlying malnutrition, which complicates management and increases the risk of adverse outcomes. Despite the clinical importance of these factors, there is limited local evidence identifying the specific determinants of mortality and severe dehydration among hospitalized children with diarrhea in this region. Understanding these determinants is essential for improving triage, clinical management, and preventive interventions. Identifying high-risk groups can support targeted nutritional programs, vaccination campaigns, and improved clinical protocols to reduce preventable deaths. Therefore, this study aims to investigate the clinical, socioeconomic, and preventive health factors associated with mortality and severe dehydration among children hospitalized with acute diarrhea in Northern State, Sudan. 2. Methodology Study Design A hospital-based prospective observational cross-sectional study will be conducted to identify determinants of mortality and severe dehydration among children admitted with acute diarrhea. Study Setting The study will be conducted in the pediatric wards of major hospitals in Northern State, Sudan, which serve as referral centers for the management of pediatric illnesses including severe diarrheal diseases. Study Population The study population will include children aged 0–59 months admitted to pediatric wards with acute diarrhea during the study period. Inclusion Criteria • Children aged 0–59 months • Hospital admission with acute diarrhea (≥3 loose stools per day with duration less than 14 days) • Parent or guardian willing to provide informed consent Exclusion Criteria • Chronic diarrhea lasting more than 14 days • Children admitted with severe unrelated medical conditions requiring intensive care • Refusal of caregiver consent Sample Size A total sample size of 400 children will be targeted. This sample size is expected to provide adequate statistical power to detect significant associations between potential risk factors and the outcomes of interest. Sampling Technique A consecutive sampling method will be used. All eligible children admitted with acute diarrhea during the study period will be recruited until the required sample size is reached. Data Collection Data will be collected using a structured questionnaire administered to caregivers and clinical examination of the child. Trained data collectors will record information on: • Demographic characteristics • Socioeconomic factors • Environmental conditions • Vaccination history • Clinical presentation • Nutritional status • Treatment provided • Clinical outcomes Data will be collected using electronic forms via Kobo Toolbox, allowing both online and offline data entry. Study Variables Independent Variables • Age • Sex • Maternal education • Source of drinking water • Rotavirus vaccination status • Nutritional status • Duration of diarrhea • Presence of vomiting • Fever • Blood in stool • Suspected etiology Outcome Variables 1. Severe dehydration 2. Mortality during hospitalization Clinical Assessment • Dehydration will be classified using WHO dehydration guidelines: o No dehydration o Some dehydration o Severe dehydration • Nutritional status will be assessed using Mid-Upper Arm Circumference (MUAC): o Severe Acute Malnutrition (<11.5 cm) o Moderate Acute Malnutrition (11.5–12.4 cm) o Normal (≥12.5 cm) Data Analysis Data will be analyzed using statistical software (such as Python or SPSS). Analysis will include: 1. Descriptive statistics o Frequencies and percentages for categorical variables o Means or medians for continuous variables 2. Bivariate analysis o Chi-square tests to examine associations between variables 3. Multivariable logistic regression o To identify independent predictors of:  Severe dehydration  Mortality Results will be presented as adjusted odds ratios (aOR) with 95% confidence intervals. Statistical significance will be considered at p < 0.05. Ethical Considerations Ethical approval will be obtained from the Research Ethics Committee of the Ministry of Health in Northern State, Sudan. • Written informed consent will be obtained from parents or guardians. • Participation will be voluntary. • All data will be collected anonymously and stored securely. • The study will follow ethical principles for research involving human participants.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☑مكتوبة / Written
☐شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
First, no personal identifiers such as the child’s name, caregiver’s name, address, or phone number will be recorded in the data collection forms. Instead, each participant will be assigned a unique study identification number that will be used for all records and analyses. Second, all data will be collected using secure electronic forms on password-protected devices. Access to the data will be restricted only to the principal investigator and authorized research team members involved in the study.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
-
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
The study will generate local epidemiological evidence on the determinants of mortality and severe dehydration among children hospitalized with acute diarrhea. Such evidence is currently limited in Northern State, and the findings will help identify the most significant clinical and socioeconomic risk factors affecting disease outcomes. Also,the results may contribute to improving early identification of high-risk children at hospital admission. Recognizing predictors such as malnutrition, vaccination status, or specific clinical symptoms will allow healthcare workers to prioritize monitoring and treatment for children at greater risk of complications or death.
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☑الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Thoraya Salah Murtada Sidahmed
التوقيع / Signature
_______________________
التاريخ / Date
2026-03-08

معلومات الباحث / Researcher Information

T

Thoraya Salah Murtada Sidahmed

thorayagzzar@gmail.com

جامعة: Alzaiem Alazhary University الكلية: Faculty of Medicine

Dongola Specialized Hospital

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

معلومات الدراسة / Study Information

ورقة علمية / Research Paper

messages.degree_research_paper - messages.degree_research_paper

21,000.00 SDG

1. Introduction Diarrheal diseases remain one of the leading causes of illness and death among children under five years of age in many low-income countries. Children in resource-limited settings frequently present with complications such as dehydration, malnutrition, and electrolyte disturbances, which significantly increase the risk of mortality. Although oral rehydration therapy and standardized treatment guidelines have substantially reduced deaths globally, diarrhea continues to pose a major health burden in Sudan. Several contextual factors contribute to this persistent burden. Limited access to clean water, inadequate sanitation, poor nutritional status, and low vaccination coverage increase children’s vulnerability to severe diarrheal illness. In addition, delayed healthcare seeking behavior and socioeconomic factors such as maternal education may influence disease severity and treatment outcomes. Northern State in Sudan faces additional healthcare challenges related to infrastructure limitations and disparities in preventive healthcare services. Children admitted to hospitals with acute diarrhea often present with advanced dehydration or underlying malnutrition, which complicates management and increases the risk of adverse outcomes. Despite the clinical importance of these factors, there is limited local evidence identifying the specific determinants of mortality and severe dehydration among hospitalized children with diarrhea in this region. Understanding these determinants is essential for improving triage, clinical management, and preventive interventions. Identifying high-risk groups can support targeted nutritional programs, vaccination campaigns, and improved clinical protocols to reduce preventable deaths. Therefore, this study aims to investigate the clinical, socioeconomic, and preventive health factors associated with mortality and severe dehydration among children hospitalized with acute diarrhea in Northern State, Sudan. 2. Methodology Study Design A hospital-based prospective observational cross-sectional study will be conducted to identify determinants of mortality and severe dehydration among children admitted with acute diarrhea. Study Setting The study will be conducted in the pediatric wards of major hospitals in Northern State, Sudan, which serve as referral centers for the management of pediatric illnesses including severe diarrheal diseases. Study Population The study population will include children aged 0–59 months admitted to pediatric wards with acute diarrhea during the study period. Inclusion Criteria • Children aged 0–59 months • Hospital admission with acute diarrhea (≥3 loose stools per day with duration less than 14 days) • Parent or guardian willing to provide informed consent Exclusion Criteria • Chronic diarrhea lasting more than 14 days • Children admitted with severe unrelated medical conditions requiring intensive care • Refusal of caregiver consent Sample Size A total sample size of 400 children will be targeted. This sample size is expected to provide adequate statistical power to detect significant associations between potential risk factors and the outcomes of interest. Sampling Technique A consecutive sampling method will be used. All eligible children admitted with acute diarrhea during the study period will be recruited until the required sample size is reached. Data Collection Data will be collected using a structured questionnaire administered to caregivers and clinical examination of the child. Trained data collectors will record information on: • Demographic characteristics • Socioeconomic factors • Environmental conditions • Vaccination history • Clinical presentation • Nutritional status • Treatment provided • Clinical outcomes Data will be collected using electronic forms via Kobo Toolbox, allowing both online and offline data entry. Study Variables Independent Variables • Age • Sex • Maternal education • Source of drinking water • Rotavirus vaccination status • Nutritional status • Duration of diarrhea • Presence of vomiting • Fever • Blood in stool • Suspected etiology Outcome Variables 1. Severe dehydration 2. Mortality during hospitalization Clinical Assessment • Dehydration will be classified using WHO dehydration guidelines: o No dehydration o Some dehydration o Severe dehydration • Nutritional status will be assessed using Mid-Upper Arm Circumference (MUAC): o Severe Acute Malnutrition (<11.5 cm) o Moderate Acute Malnutrition (11.5–12.4 cm) o Normal (≥12.5 cm) Data Analysis Data will be analyzed using statistical software (such as Python or SPSS). Analysis will include: 1. Descriptive statistics o Frequencies and percentages for categorical variables o Means or medians for continuous variables 2. Bivariate analysis o Chi-square tests to examine associations between variables 3. Multivariable logistic regression o To identify independent predictors of:  Severe dehydration  Mortality Results will be presented as adjusted odds ratios (aOR) with 95% confidence intervals. Statistical significance will be considered at p < 0.05. Ethical Considerations Ethical approval will be obtained from the Research Ethics Committee of the Ministry of Health in Northern State, Sudan. • Written informed consent will be obtained from parents or guardians. • Participation will be voluntary. • All data will be collected anonymously and stored securely. • The study will follow ethical principles for research involving human participants.

Mar 17, 2026 - May 06, 2026

Mar 24, 2026 - Apr 15, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Written

مخاطر منخفضة - Low Risk

First, no personal identifiers such as the child’s name, caregiver’s name, address, or phone number will be recorded in the data collection forms. Instead, each participant will be assigned a unique study identification number that will be used for all records and analyses. Second, all data will be collected using secure electronic forms on password-protected devices. Access to the data will be restricted only to the principal investigator and authorized research team members involved in the study.

The study will generate local epidemiological evidence on the determinants of mortality and severe dehydration among children hospitalized with acute diarrhea. Such evidence is currently limited in Northern State, and the findings will help identify the most significant clinical and socioeconomic risk factors affecting disease outcomes. Also,the results may contribute to improving early identification of high-risk children at hospital admission. Recognizing predictors such as malnutrition, vaccination status, or specific clinical symptoms will allow healthcare workers to prioritize monitoring and treatment for children at greater risk of complications or death.

Children