NCT06146400

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 19, 2023

Last Update Submit

November 19, 2023

Conditions

Outcome Measures

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

    Baseline

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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%

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Amera A. Saber, Researcher

CONTACT

Reem M. Abdelkhalik, Ass.lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 24, 2023

Study Start

December 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11