Pediatric Emergency MedicineNCT06577207
Pattern and Outcome of Children Admitted in Emergency Unit of Assuit Children University Hospital Hospital
An observational study of Pediatric Emergency Medicine, run by Assiut University.
Trial summary
In the present work, we aim to 1. Describe the pattern of patients admitted to Emergency unite at Assiut University Child Hospital (AUCH) and classify them according to age ,distribution ,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to… Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Pediatric Emergency Medicine
- What is being tested?
- Initial investigations for all cases
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The present study is a cross-sectional study.study will be carried out on patients admitted to Emergency unite at Assiut University Child Hospital (AUCH) .An informed consent will be obtained from all patients. The study will be conducted in Assiut university child hospital, during the period from Jan 2025 to Jan 2026 .The purpose and nature of the study will be explained to all patients. At least 94 patients will be included in the present study. The sample size was calculated using Epi-info version 7software,Based on previous studies, the confidence limits of 5% , a confidence level =80% ,and the rate of pediatric patients emergency admission as 50% , and allocation ratio of 1.
Who may be able to join
- All patients from 28 day till 18 years who will be admitted to emergency unite at (AUCH) during duration of the study,data of the patients will be collected in the form of :
- Full history taking:
- Personal history: (age, sex, gestational age), residence and socioeconomic status.
- Cause of admission and clinical characteristic of patients (medical or surgical condition).
- Triage and acuity : rapidly screening of sick children in order to identify: • those with emergency signs, who require immediate emergency treatment; • those with priority signs, who are at higher risk of dying.
- These children should be assessed without unnecessary delay. • non-urgent cases, who have neither emergency nor priority signs. Emergency signs include: obstructed or absent breathing, severe respiratory distress, central cyanosis, signs of shock, coma, convulsions, signs of severe dehydration . The priority signs include: any sick child aged < 2 months, very high temperature, severe pallor, history of poisoning, severe pain, restless or continuously irritable, edema of both feet
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- Associated symptoms of different systems involved.
- Provisional diagnosis.
- 1 st admission or not
- Referring center , time and seasonal variation to detect most peak area and months
- Fate
- Complete physical examination: Including body temperature , respiratory rate, heart rate, pallor, weight loss, and evidence of dehydration. Chest, cardiac , abdominal and neurological examination.
- Investigations and Imaging: Initial investigations for all cases: 1. Pulse oximetry. 2. Complete blood count. 3. Electrolytes. 4. Kidney function test. 5. Random blood glucose 6. Other investigations ordered for certain cases according to clinical manifestation \& previous findings > Lines of treatment will be recorded
- Patients will be followed during their stay in ER and till discharge patient to home or refer him to specific unit in pediatric hospital with monitoring of factors affecting their prognosis.
Who cannot join
- Neonates
- patients which their age are more than 18 years
- Patients which have recent trauma
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pattern and Outcome of Children Admitted in Emergency Unit of Assuit Children University Hospital
In the present work, we aim to
- Describe the pattern of patients admitted to Emergency unite at Assiut University Child Hospital (AUCH) and classify them according to age ,distribution ,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to home or refer him to specific unit in pediatric hospital and associated chronic disease.
- Describe factors affecting mortality rate
Read the detailed description
Emergency department (ED) is the essential and important front line of medical care provided by the hospital. Child mortality rates remain high globally; mortality rate is a reflection of the severity of illness and the quality of treatment of patients in pediatric emergency departments . In Africa, the childhood mortality rate is 92 per 1000 live births which are 15 times more than that of well-resourced countries. In pediatric departments, early child mortality is commonly caused by preventable and reversible diseases, so urgent treatment and resuscitation are required to avoid poor outcomes . Overcrowding in ED has also been a global urgent problems , overcrowded could be brought by multiple factors as a facility with rapid diagnostic modalities and early initiation of therapy and patients can expect a higher possibility to be admitted to the hospital by the ED attendant . Early identification and treatment of pneumonia, sepsis, heart failure (secondary to anemia), acute respiratory tract infections, and diarrheal diseases has been shown to reduce childhood mortality in acute pediatric hospitals. Critical clinical issues, such as shortness of breath, fast breathing and fever with seizure are some of the preventable causes contributing to childhood mortality. Effective intervention and good emergency care and classification of children requires effort and coordination starting from the bedside up to the governmental level .
- Conditions
- Pediatric Emergency Medicine
- Being tested
- Initial investigations for all cases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial investigations for all casesOther
Initial investigations for all cases: 1. Pulse oximetry. 2. Complete blood count. 3. Electrolytes. 4. Kidney function test. 5. Random blood glucose 6. Other investigations ordered for certain cases according to clinical manifestation \& previous findings > Lines of treatment will be recorded
What is being measured
The primary outcome is the main question the study is designed to answer.
classification of pediatric patient in emergency room
classification of pediatric patient in emergency room according to age distribution
,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to home or refer him to specific unit in pediatric hospital and associated chronic disease.
Measured: baseline
Secondary outcomes (1)
search for factors affect mortality rate
search for factors affect mortality rate
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pediatric Emergency MedicineStudies 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
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ereeny louiz Azmy Sorieal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577207
- Sponsor's protocol ID
- children in Emergency Unit
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rothman RE, Irvin CB, Moran GJ, Sauer L, Bradshaw YS, Fry RB Jr, Josephson EB, Ledyard HK, Hirshon JM; Public Health Committee of the American College of Emergency Physicians. Respiratory hygiene in the emergency department. Ann Emerg Med. 2006 Nov;48(5):570-82. doi: 10.1016/j.annemergmed.2006.05.018. Epub 2006 Aug 23.
PubMed 17052558Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
PubMed 25280870
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern and Outcome of Children Admitted in Emergency Unit of Assuit Children University Hospital
- ClinicalTrials.gov ID
- NCT06577207
- Acronym / sponsor ID
- children in Emergency Unit
- Conditions
- Pediatric Emergency Medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Aug 2024 (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.
In the present work, we aim to
- Describe the pattern of patients admitted to Emergency unite at Assiut University Child Hospital (AUCH) and classify them according to age ,distribution ,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to home or refer him to specific unit in pediatric hospital and associated chronic disease.
- Describe factors affecting mortality rate
Detailed description
Emergency department (ED) is the essential and important front line of medical care provided by the hospital. Child mortality rates remain high globally; mortality rate is a reflection of the severity of illness and the quality of treatment of patients in pediatric emergency departments . In Africa, the childhood mortality rate is 92 per 1000 live births which are 15 times more than that of well-resourced countries. In pediatric departments, early child mortality is commonly caused by preventable and reversible diseases, so urgent treatment and resuscitation are required to avoid poor outcomes . Overcrowding in ED has also been a global urgent problems , overcrowded could be brought by multiple factors as a facility with rapid diagnostic modalities and early initiation of therapy and patients can expect a higher possibility to be admitted to the hospital by the ED attendant . Early identification and treatment of pneumonia, sepsis, heart failure (secondary to anemia), acute respiratory tract infections, and diarrheal diseases has been shown to reduce childhood mortality in acute pediatric hospitals. Critical clinical issues, such as shortness of breath, fast breathing and fever with seizure are some of the preventable causes contributing to childhood mortality. Effective intervention and good emergency care and classification of children requires effort and coordination starting from the bedside up to the governmental level .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The present study is a cross-sectional study.study will be carried out on patients admitted to Emergency unite at Assiut University Child Hospital (AUCH) .An informed consent will be obtained from all patients. The study will be conducted in Assiut university child hospital, during the period from Jan 2025 to Jan 2026 .The purpose and nature of the study will be explained to all patients. At least 94 patients will be included in the present study. The sample size was calculated using Epi-info version 7software,Based on previous studies, the confidence limits of 5% , a confidence level =80% ,and the rate of pediatric patients emergency admission as 50% , and allocation ratio of 1.
Key inclusion criteria (14 listed)
- All patients from 28 day till 18 years who will be admitted to emergency unite at (AUCH) during duration of the study,data of the patients will be collected in the form of :
- These children should be assessed without unnecessary delay. • non-urgent cases, who have neither emergency nor priority signs. Emergency signs include: obstructed or absent breathing, severe respiratory distress, central cyanosis, signs of shock, coma, convulsions, signs of severe dehydration . The priority signs include: any sick child aged < 2 months, very high temperature, severe pallor, history of poisoning, severe pain, restless or continuously irritable, edema of both feet
Key exclusion criteria (3 listed)
- Neonates
- patients which their age are more than 18 years
- Patients which have recent trauma
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 |
|---|---|---|
| Initial investigations for all casesInitial investigations for all cases: 1. Pulse oximetry. 2. Complete blood count. 3. Electrolytes. 4. Kidney function test. 5. Random blood glucose 6. Other investigations ordered for certain cases according to clinical manifestation \& previous findings > Lines of treatment will be recorded | Other | – |
Primary outcome
classification of pediatric patient in emergency room
Time frame: baseline
classification of pediatric patient in emergency room according to age distribution ,most common presenting complain, effect of seasonal variation on causes of admission ,prognosis till discharge of the patient to home or refer him to specific unit in pediatric hospital and associated chronic disease.
1 secondary outcome
search for factors affect mortality rate
Time frame: baseline
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 3 Sep 2024.
- Background: PubMed 17052558Rothman RE, Irvin CB, Moran GJ, Sauer L, Bradshaw YS, Fry RB Jr, Josephson EB, Ledyard HK, Hirshon JM; Public Health Committee of the American College of Emergency Physicians. Respiratory hygiene in the emergency department. Ann Emerg Med. 2006 Nov;48(5):570-82. doi: 10.1016/j.annemergmed.2006.05.018. Epub 2006 Aug 23.
- Background: PubMed 25280870Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Emergency Medicine, 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 14 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: opening soon, as of the sponsor's last update on 3 Sep 2024. 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?
Contact Ereeny louiz Azmy, master (+201025898896, ereny.louiz.azmy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
classification of pediatric patient in emergency room (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 NCT06577207, which also lists 2 linked publications.
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 3 Sep 2024.