Acute GastroenteritisNCT06038305
Prevalence of Anemia and Growth Assessment in Acute Gastroenteritis
An observational study of Acute Gastroenteritis, run by Assiut University at 1 site in Egypt.
Trial summary
1. Assessment of the growth parameters in infants admitted with acute gastroenteritis. 2. Determine the prevalence of anemia in infants admitted with acute gastroenteritis. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Acute Gastroenteritis
- How many people
- 297 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Feb 2025
- 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 1 month to 2 years
- All sexes
- Child
Study population: infants aged 1 month up to 2 years with acute gastroenteritis
Who may be able to join
- Infants with acute gastroenteritis.
- Infants aged from 1 month and up to 2 years.
Who cannot join
- Infants aged less than 1 month and more than 2 years.
- Infants with persistent and chronic diarrhea.
- Infants with acute gastroenteritis in association with chronic disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Ashraf M El-saghier, Professor, +201026746762, Shereif@aun.edu.eg
About this study
Official title: Prevalence of Anemia and Growth Assessment of Children Admitted With Acute Gastroenteritis in Assiut University Children Hospital
- Assessment of the growth parameters in infants admitted with acute gastroenteritis.
- Determine the prevalence of anemia in infants admitted with acute gastroenteritis.
Read the detailed description
Gastroenteritis is inflammation of the stomach, small intestine, or large intestine, leading to a combination of abdominal pain, cramping, nausea, vomiting, and diarrhea. Acute gastroenteritis usually lasts fewer than 14 days. Worldwide, gastroenteritis affects 3 to 5 billion children each year. Up to 40% of children aged less than 5 years with diarrhea are hospitalized with rotavirus. Also, some microorganisms have been found predominantly in resource-constrained nations, including Shigella spp, Vibrio cholerae, and the protozoan infections. Malnutrition, immunosuppression, young age, and an increase in the preceding diarrhea burdens are risk factors for the development of persistent diarrhea. A substantial proportion of global malnutrition is due to impaired intestinal absorptive function resulting from multiple and repeated enteric infections. These include recurrent acute infections as well as persistent infections, even those without overt liquid diarrhea.
Child growth is internationally recognized as the best global indicator of physical well-being in children because poor feeding practices-both in quantity and quality-and infections, or more often a combination of the two, are major factors that affect physical growth and mental development in children. The most important measurements needed for growth assessment are recumbent length or height, weight and head circumference. These fundamental anthropometric measures should be obtained and interpreted at each well child visit, and are typically sufficient for growth assessment.
In this study, the prevalence of anemia and growth of infants admitted with acute gastroenteritis at Assiut University Children Hospital will be assessed. Anemia is a global public health problem, with important consequences for human health and the social and economic development of each nation. It results from single or multiple causes that act simultaneously, influencing children's health, their cognitive and physical development, and immunity, increasing the risk of infections and infant mortality.
- Conditions
- Acute Gastroenteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine association between anemia and acute gastroenteritis in infants and children.
assess anemia in children with acute gastroenteritis and if anemia affect severity of acute gastroenteritis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Jan 2024
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Ali Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038305
- Sponsor's protocol ID
- anemia and growth in AGE
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anemia and Growth Assessment of Children Admitted With Acute Gastroenteritis in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06038305
- Acronym / sponsor ID
- anemia and growth in AGE
- Conditions
- Acute Gastroenteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 14 Sep 2023 (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.
- Assessment of the growth parameters in infants admitted with acute gastroenteritis.
- Determine the prevalence of anemia in infants admitted with acute gastroenteritis.
Detailed description
Gastroenteritis is inflammation of the stomach, small intestine, or large intestine, leading to a combination of abdominal pain, cramping, nausea, vomiting, and diarrhea. Acute gastroenteritis usually lasts fewer than 14 days. Worldwide, gastroenteritis affects 3 to 5 billion children each year. Up to 40% of children aged less than 5 years with diarrhea are hospitalized with rotavirus. Also, some microorganisms have been found predominantly in resource-constrained nations, including Shigella spp, Vibrio cholerae, and the protozoan infections. Malnutrition, immunosuppression, young age, and an increase in the preceding diarrhea burdens are risk factors for the development of persistent diarrhea. A substantial proportion of global malnutrition is due to impaired intestinal absorptive function resulting from multiple and repeated enteric infections. These include recurrent acute infections as well as persistent infections, even those without overt liquid diarrhea.
Child growth is internationally recognized as the best global indicator of physical well-being in children because poor feeding practices-both in quantity and quality-and infections, or more often a combination of the two, are major factors that affect physical growth and mental development in children. The most important measurements needed for growth assessment are recumbent length or height, weight and head circumference. These fundamental anthropometric measures should be obtained and interpreted at each well child visit, and are typically sufficient for growth assessment.
In this study, the prevalence of anemia and growth of infants admitted with acute gastroenteritis at Assiut University Children Hospital will be assessed. Anemia is a global public health problem, with important consequences for human health and the social and economic development of each nation. It results from single or multiple causes that act simultaneously, influencing children's health, their cognitive and physical development, and immunity, increasing the risk of infections and infant mortality.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- infants aged 1 month up to 2 years with acute gastroenteritis
Key inclusion criteria (2 listed)
- Infants with acute gastroenteritis.
- Infants aged from 1 month and up to 2 years.
Key exclusion criteria (3 listed)
- Infants aged less than 1 month and more than 2 years.
- Infants with persistent and chronic diarrhea.
- Infants with acute gastroenteritis in association with chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine association between anemia and acute gastroenteritis in infants and children.
Time frame: baseline
assess anemia in children with acute gastroenteritis and if anemia affect severity of acute gastroenteritis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastroenteritis, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dalia G Mahran (+201007120821 ext. Professor, Daliaym2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine association between anemia and acute gastroenteritis in infants and children. (time frame: baseline). 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 1 Nov 2024.