Respiratory IllnessesNCT05691127
Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome
An observational study of Respiratory Illnesses, run by Sohag University at 1 site in Egypt.
Trial summary
Acute respiratory infections (ARI) are an important cause of mortality and morbidity among children; one-fifths of under-five mortality being contributed by them (predominantly pneumonias ). Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Respiratory Illnesses
- What is being tested?
- Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, Creatinine
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2023to Jan 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness
Who may be able to join
- Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness
Who cannot join
- Post trauma case. Postoperative cases (developing respiratory complications during PICU stay).
Trial locations and contacts
1 site in 1 country.
Shaimaa M Mahmoud, Assistant professor contact
About this study
Acute respiratory infections (ARI) are an important cause of mortality and morbidity among children; one-fifths of under-five mortality being contributed by them (predominantly pneumonias ).
About 11.9 million episodes of severe and 3.0 million episodes of very severe acute lower respiratory infections (ALRI) result in hospital admissions in young children worldwide.
Respiratory infections and illnesses in children thus form a substantial disease burden in Pediatric intensive care unit. With this is mind, we studied clinical profile and risk factors contributing to mortality, and outcome of children with acute respiratory infections.
- Conditions
- Respiratory Illnesses
- Being tested
- Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, Creatinine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, CreatinineDiagnostic test
I will use these investigations in my study
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Diseased children | Not described Receives: Diagnostic Test: Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, Creatinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of respiratory illnesses
incidence of respiratory illnesses in PICU among other children
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory IllnessesStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadier Khaled Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691127
- Sponsor's protocol ID
- soh-Med-22-12-08
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khilnani P, Sarma D, Singh R, Uttam R, Rajdev S, Makkar A, Kaur J. Demographic profile and outcome analysis of a tertiary level pediatric intensive care unit. Indian J Pediatr. 2004 Jul;71(7):587-91. doi: 10.1007/BF02724117.
PubMed 15280607Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
PubMed 23369797Tan GH, Tan TH, Goh DY, Yap HK. Risk factors for predicting mortality in a paediatric intensive care unit. Ann Acad Med Singap. 1998 Nov;27(6):813-8.
PubMed 10101556
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Respiratory Illnesses in Pediatric Intensive Care Unit and Its Outcome
- ClinicalTrials.gov ID
- NCT05691127
- Acronym / sponsor ID
- soh-Med-22-12-08
- Conditions
- Respiratory Illnesses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Jan 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.
Acute respiratory infections (ARI) are an important cause of mortality and morbidity among children; one-fifths of under-five mortality being contributed by them (predominantly pneumonias ).
About 11.9 million episodes of severe and 3.0 million episodes of very severe acute lower respiratory infections (ALRI) result in hospital admissions in young children worldwide.
Respiratory infections and illnesses in children thus form a substantial disease burden in Pediatric intensive care unit. With this is mind, we studied clinical profile and risk factors contributing to mortality, and outcome of children with acute respiratory infections.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Diseased children | – | Diagnostic Test: Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, Creatinine |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness
Key inclusion criteria (1 listed)
- Children with pneumonia, bronchiolitis, bronchial asthma, chemical pneumonitis, cystic fibrosis and other respiratory diseases, Cardiorespiratory cases and Neurological cases with respiratory illness
Key exclusion criteria (1 listed)
- Post trauma case. Postoperative cases (developing respiratory complications during PICU stay).
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 |
|---|---|---|
| Complete blood count (CBC), C reactive protein (CRP(., Chest x ray, ABG, Electrolytes, Random blood sugar, CreatinineI will use these investigations in my study | Diagnostic test | Respiratory Diseased children |
Primary outcome
incidence of respiratory illnesses
Time frame: one year
incidence of respiratory illnesses in PICU among other children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 15280607Khilnani P, Sarma D, Singh R, Uttam R, Rajdev S, Makkar A, Kaur J. Demographic profile and outcome analysis of a tertiary level pediatric intensive care unit. Indian J Pediatr. 2004 Jul;71(7):587-91. doi: 10.1007/BF02724117.
- Background: PubMed 23369797Nair H, Simoes EA, Rudan I, Gessner BD, Azziz-Baumgartner E, Zhang JSF, Feikin DR, Mackenzie GA, Moiisi JC, Roca A, Baggett HC, Zaman SM, Singleton RJ, Lucero MG, Chandran A, Gentile A, Cohen C, Krishnan A, Bhutta ZA, Arguedas A, Clara AW, Andrade AL, Ope M, Ruvinsky RO, Hortal M, McCracken JP, Madhi SA, Bruce N, Qazi SA, Morris SS, El Arifeen S, Weber MW, Scott JAG, Brooks WA, Breiman RF, Campbell H; Severe Acute Lower Respiratory Infections Working Group. Global and regional burden of hospital admissions for severe acute lower respiratory infections in young children in 2010: a systematic analysis. Lancet. 2013 Apr 20;381(9875):1380-1390. doi: 10.1016/S0140-6736(12)61901-1. Epub 2013 Jan 29.
- Background: PubMed 10101556Tan GH, Tan TH, Goh DY, Yap HK. Risk factors for predicting mortality in a paediatric intensive care unit. Ann Acad Med Singap. 1998 Nov;27(6):813-8.
- Individual participant dataSharing planned: Undecided
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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.
Shaimaa M Mahmoud, Assistant professor contact
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 Respiratory Illnesses, run by Sohag 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 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 3 Feb 2023. 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 Hadier K Mahmoud, resident (01061158888, hader011218@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of respiratory illnesses (time frame: one year). 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 NCT05691127, which also lists 3 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 Feb 2023.