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Not yet recruitingNCT06146400Updated Nov 24, 2023

Role of CBC Parameters in Early Diagnosis of Pediatric Pneumonia

An observational study in Pediatric Infectious Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
1 Year to 5 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Pediatric Infectious Disease
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 100 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Sampling method
Non-probability sample

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%

Inclusion criteria

-

Newly suspected cases of pneumonia from age o 1 month to 5 years in 2 age groups

Exclusion criteria

Exclusion Criteria:

  • Age group >5 years
  • Already diagnosed patient who is under treatment
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06146400
Lead sponsor
Assiut University
Responsible party
Amira Abdeltwab saber (Principle investigator, Assiut University) — Principal investigator
First posted
Nov 24, 2023
Start date
Dec 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Nov 24, 2023

Study contacts

Amera A. Saber, Researcher
Contact
merhelsherif51@gmail.com
01027743031
Reem M. Abdelkhalik, Ass.lecturer
Contact
01030059505

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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