Pediatric Infectious DiseaseNCT06146400
Role of CBC Parameters in Early Diagnosis of Pediatric Pneumonia
An observational study of Pediatric Infectious Disease, run by Assiut University.
Trial summary
Detection of the role of Complete Blood Count (CBC) parameters in early diagnosis of pediatric pneumonia -Testing the ability of Complete Blood Count (CBC) parameters (N/L ratio, PLT /MPV ratio, MPV and other parameters) to differentiate between viral and bacterial pneumonia. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Pediatric Infectious Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Feb 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 year to 5 years
- All sexes
- Child
Study population: * Based on determining the main outcome variable, the estimated minimum required sample size is 80 suspected cases of pneumonia and 80 controls. * The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is the role of Complete Blood Count (CBC) parameters in early diagnosis of pediatric pneumonia. Based on previous studies (put reference) the percentage children of under 5 years who had pneumonia was 25.6% and based on the percentage confidence limits of 6% and a Confidence level =80%
Who may be able to join
- -
- Newly suspected cases of pneumonia from age o 1 month to 5 years in 2 age groups
Who cannot join
- Age group >5 years
- Already diagnosed patient who is under treatment
Trial locations and contacts
No sites are listed yet.
Reem M. Abdelkhalik, Ass.lecturer contact
About this study
Official title: Role of CBC Parameters in Early Diagnosis of Bacterial and Viral Pediatric Pneumonia
Detection of the role of Complete Blood Count (CBC) parameters in early diagnosis of pediatric pneumonia
-Testing the ability of Complete Blood Count (CBC) parameters (N/L ratio, PLT /MPV ratio, MPV and other parameters) to differentiate between viral and bacterial pneumonia.
Read the detailed description
Pneumonia is the leading cause of hospitalizations and death among children with nearly 120 million new cases and one million deaths every year.
- Viruses are the main cause of pneumonia in infants and toddlers between 30 days and 2 years old.
- Children 2 to 5 years old, respiratory viruses are also common with the rise of cases related to S. pneumoniae and H. influenzae type B and other bacterial organisms.
Viral pneumonia caused by , respiratory syncytial virus, which are the most common cause of community- acquired pneumonia in children younger than 5 years. Streptococcus pneumoniae is the most common bacterial cause across all age groups. Other important bacterial causes in children younger than 5 years include Hemophilus influenzae, Streptococcus pyogenes, Staphylococcus aureus, and Moraxella catarrhalis.
Parapneumonic effusion/empyema (PPE/EP), necrosis of lung parenchyma (NC), and lung abscess (AB), are serious complication of pediatric pneumonia. Because of these serious complications, early diagnosis of the causative organism is very important to start the proper treatment and avoid these serious complications.
Complete Blood Picture (CBC) is one of the most important preliminary routine investigations for diagnosis and monitoring of infection.
Recently, CBC parameters, especially Total Leucocyte Count (TLC), ANC, and platelet count all showed significant associations with neonatal sepsis. Besides, the TLC,Absolute neutrophils count (ANC), and platelet counts had good sensitivity and specificity in diagnosing neonatal sepsis
Another study have assessed the utility of C-reactive protein (CRP), White Cell Count (WCC), Neutrophil/Lymphocyte ratio (N/L), Platelets/ Mean Platelets Volume ratio (PLT/MPV ratio), Mean Platelets Volume (MPV), Monocyte Distribution Width (MDW) and many other CBC ratios to differentiate probable bacterial infections from non-bacterial infections and also assessed the severity of illness.
- In this study, we are going to test the role of Complete Blood Picture (CBC) parameters and ratios as an early detection tool of bacterial and viral pneumonia. This might have a role in early prediction and diagnosis of the causative organism. Which in turn leads to rapid intervention, and better prognosis.
- Conditions
- Pediatric Infectious Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
role of CBC parameters and ratios in early diagnosis of pediatric pneumonia - Detecting the role of Complete Blood Picture parameters and ratios in early diagnosis of pediatric pneumonia CBC Parameters in diagnosis pediatric pneumonia
CBC parameters and ratios N/L Ratio PLT/MPV ratio ,MPV in differentiation between bacterial and viral pneumonia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study startDec 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Infectious DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Abdeltwab saber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146400
- Sponsor's protocol ID
- pediatric pneumonia
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CBC Parameters in Early Diagnosis of Bacterial and Viral Pediatric Pneumonia
- ClinicalTrials.gov ID
- NCT06146400
- Acronym / sponsor ID
- pediatric pneumonia
- Conditions
- Pediatric Infectious Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 24 Nov 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.
Detection of the role of Complete Blood Count (CBC) parameters in early diagnosis of pediatric pneumonia
-Testing the ability of Complete Blood Count (CBC) parameters (N/L ratio, PLT /MPV ratio, MPV and other parameters) to differentiate between viral and bacterial pneumonia.
Detailed description
Pneumonia is the leading cause of hospitalizations and death among children with nearly 120 million new cases and one million deaths every year.
- Viruses are the main cause of pneumonia in infants and toddlers between 30 days and 2 years old.
- Children 2 to 5 years old, respiratory viruses are also common with the rise of cases related to S. pneumoniae and H. influenzae type B and other bacterial organisms.
Viral pneumonia caused by , respiratory syncytial virus, which are the most common cause of community- acquired pneumonia in children younger than 5 years. Streptococcus pneumoniae is the most common bacterial cause across all age groups. Other important bacterial causes in children younger than 5 years include Hemophilus influenzae, Streptococcus pyogenes, Staphylococcus aureus, and Moraxella catarrhalis.
Parapneumonic effusion/empyema (PPE/EP), necrosis of lung parenchyma (NC), and lung abscess (AB), are serious complication of pediatric pneumonia. Because of these serious complications, early diagnosis of the causative organism is very important to start the proper treatment and avoid these serious complications.
Complete Blood Picture (CBC) is one of the most important preliminary routine investigations for diagnosis and monitoring of infection.
Recently, CBC parameters, especially Total Leucocyte Count (TLC), ANC, and platelet count all showed significant associations with neonatal sepsis. Besides, the TLC,Absolute neutrophils count (ANC), and platelet counts had good sensitivity and specificity in diagnosing neonatal sepsis
Another study have assessed the utility of C-reactive protein (CRP), White Cell Count (WCC), Neutrophil/Lymphocyte ratio (N/L), Platelets/ Mean Platelets Volume ratio (PLT/MPV ratio), Mean Platelets Volume (MPV), Monocyte Distribution Width (MDW) and many other CBC ratios to differentiate probable bacterial infections from non-bacterial infections and also assessed the severity of illness.
- In this study, we are going to test the role of Complete Blood Picture (CBC) parameters and ratios as an early detection tool of bacterial and viral pneumonia. This might have a role in early prediction and diagnosis of the causative organism. Which in turn leads to rapid intervention, and better prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Age groups
- Child
- Study population
- * Based on determining the main outcome variable, the estimated minimum required sample size is 80 suspected cases of pneumonia and 80 controls. * The sample size was calculated using Epi-info version 7 software, based on the following assumptions: Main outcome variable is the role of Complete Blood Count (CBC) parameters in early diagnosis of pediatric pneumonia. Based on previous studies (put reference) the percentage children of under 5 years who had pneumonia was 25.6% and based on the percentage confidence limits of 6% and a Confidence level =80%
Key inclusion criteria (2 listed)
- -
- Newly suspected cases of pneumonia from age o 1 month to 5 years in 2 age groups
Key exclusion criteria (2 listed)
- Age group >5 years
- Already diagnosed patient who is under treatment
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
role of CBC parameters and ratios in early diagnosis of pediatric pneumonia - Detecting the role of Complete Blood Picture parameters and ratios in early diagnosis of pediatric pneumonia CBC Parameters in diagnosis pediatric pneumonia
Time frame: Baseline
CBC parameters and ratios N/L Ratio PLT/MPV ratio ,MPV in differentiation between bacterial and viral pneumonia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- 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.
Reem M. Abdelkhalik, Ass.lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Infectious Disease, 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 2 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 24 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amera A. Saber, Researcher (01027743031, merhelsherif51@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
role of CBC parameters and ratios in early diagnosis of pediatric pneumonia - Detecting the role of Complete Blood Picture parameters and ratios in early diagnosis of pediatric pneumonia CBC Parameters in diagnosis pediatric pneumonia (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 24 Nov 2023.