Acute Respiratory Distress SyndromeNCT07149389
Assessment of Acute Respiratory Distress in Children Presenting to the Emergency Department: Clinical, Epidemiological, and Etiological Insights
An observational study of Acute Respiratory Distress Syndrome, run by Assiut University.
Trial summary
This study investigates the clinical and epidemiological characteristics of children with acute respiratory distress presenting to the emergency unit at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of pediatric patients from urban and rural areas of Upper Egypt who seek emergency care for acute respiratory distress. The cohort reflects diverse socioeconomic backgrounds, maternal education levels, and environmental exposures such as household air quality and passive smoking. The children present with various severities of respiratory distress caused by multiple etiologies including pulmonary, cardiac, infectious, metabolic, and neurological factors. Nutritional assessments and developmental milestones are documented as potential modifiers of disease presentation and outcomes. Comprehensive laboratory tests and imaging help confirm diagnoses and severity, with particular attention to those at higher risk of complications. As such, this population offers a representative sample of pediatric ARD patients in a regional tertiary care center.
Who may be able to join
- Children aged 1 month to 18 years
- children presenting to the emergency department with acute respiratory distress.
Who cannot join
- Patients older than 18 years or younger than 1 month.
About this study
Official title: A Clinical and Epidemiological Study of Children With Acute Respiratory Distress Presenting to the Emergency Unit at Assiut University Children Hospital, Egypt
This study investigates the clinical and epidemiological characteristics of children with acute respiratory distress presenting to the emergency unit at Assiut University Children Hospital. It aims to determine the prevalence, causes, and risk factors to improve understanding and management of this critical pediatric condition.
Read the detailed description
This descriptive cross-sectional study will be conducted over six months in the pediatrics emergency department of Assiut University Hospital, Egypt. It enrolls children aged 1 month to 18 years presenting with acute respiratory distress (ARD). The study collects detailed demographic, clinical, environmental, nutritional, and developmental data using a structured, pre-tested case record form. It includes comprehensive patient history, physical examination, laboratory and radiological investigations to identify underlying causes, clinical features, and risk factors for ARD. Data will be analyzed statistically using SPSS software to characterize the epidemiology and clinical spectrum, inclusion of factors like exposure to passive smoking, socioeconomic status, and detailed symptomatology, aiming to contribute to better diagnosis, treatment, and prevention strategies in this resource-limited setting
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratory distress, ARD
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute respiratory distress patients | Children aged between 1 month and 18 years presenting with acute respiratory distress at the emergency department of Assiut University Children Hospital are studied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute respiratory distress among children
Measurement of how frequently ARD occurs in children presenting at the emergency department
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ayman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149389
- Sponsor's protocol ID
- Children with ARD
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kango SC, Yanza MCAS, Komba JEK, Mandé M, -Njapou, Gody JC, et al. Epidemiological, Clinical and Therapeutic Aspects of Acute Respiratory Distress in Children in Medical Emergencies at the Bangui Pediatric University Hospital. Open J Pediatr 2025;15:111-8. https://doi.org/10.4236/OJPED.2025.151011.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical and Epidemiological Study of Children With Acute Respiratory Distress Presenting to the Emergency Unit at Assiut University Children Hospital, Egypt
- ClinicalTrials.gov ID
- NCT07149389
- Acronym / sponsor ID
- Children with ARD
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratory distress, ARD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 2 Sep 2025 (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.
This study investigates the clinical and epidemiological characteristics of children with acute respiratory distress presenting to the emergency unit at Assiut University Children Hospital. It aims to determine the prevalence, causes, and risk factors to improve understanding and management of this critical pediatric condition.
Detailed description
This descriptive cross-sectional study will be conducted over six months in the pediatrics emergency department of Assiut University Hospital, Egypt. It enrolls children aged 1 month to 18 years presenting with acute respiratory distress (ARD). The study collects detailed demographic, clinical, environmental, nutritional, and developmental data using a structured, pre-tested case record form. It includes comprehensive patient history, physical examination, laboratory and radiological investigations to identify underlying causes, clinical features, and risk factors for ARD. Data will be analyzed statistically using SPSS software to characterize the epidemiology and clinical spectrum, inclusion of factors like exposure to passive smoking, socioeconomic status, and detailed symptomatology, aiming to contribute to better diagnosis, treatment, and prevention strategies in this resource-limited setting
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute respiratory distress patients | – | –Children aged between 1 month and 18 years presenting with acute respiratory distress at the emergency department of Assiut University Children Hospital are studied |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of pediatric patients from urban and rural areas of Upper Egypt who seek emergency care for acute respiratory distress. The cohort reflects diverse socioeconomic backgrounds, maternal education levels, and environmental exposures such as household air quality and passive smoking. The children present with various severities of respiratory distress caused by multiple etiologies including pulmonary, cardiac, infectious, metabolic, and neurological factors. Nutritional assessments and developmental milestones are documented as potential modifiers of disease presentation and outcomes. Comprehensive laboratory tests and imaging help confirm diagnoses and severity, with particular attention to those at higher risk of complications. As such, this population offers a representative sample of pediatric ARD patients in a regional tertiary care center.
Key inclusion criteria (2 listed)
- Children aged 1 month to 18 years
- children presenting to the emergency department with acute respiratory distress.
Key exclusion criteria (1 listed)
- Patients older than 18 years or younger than 1 month.
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
Incidence of acute respiratory distress among children
Time frame: Baseline
Measurement of how frequently ARD occurs in children presenting at the emergency department
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- BackgroundKango SC, Yanza MCAS, Komba JEK, Mandé M, -Njapou, Gody JC, et al. Epidemiological, Clinical and Therapeutic Aspects of Acute Respiratory Distress in Children in Medical Emergencies at the Bangui Pediatric University Hospital. Open J Pediatr 2025;15:111-8. https://doi.org/10.4236/OJPED.2025.151011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Assiut 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 2 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: opening soon, as of the sponsor's last update on 2 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute respiratory distress among children (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149389, which also lists 1 linked publication.
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 2 Sep 2025.