Inflammatory Markers and Cbc Indices in Severely Malnourished Children

August 13, 2021 updated by: Meret Michael Fahmy, Assiut University

Correlation Between Inflammatory Markers and Complete Blood Film Indices (White Blood Cells and Platelets ) in Severely Malnourished Children

The main objectives of this study were to correlate between inflammatory markers and cbc indices in severly malnourished children and to determine whether children with SAM can mount an acute phase reactant response namely CRP and to evaluate the usefulness of quantitative CRP as a predictor of severe infections in children with SAM.

And to correlate between inflammatory markers and CBC indices (mainly white blood cells and platelets in those children .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Malnutrition remains one of the most common causes of morbidity and mortality among children throughout the world.

Malnutrition is a pathological state resulting from a relative or absolute deficiency or excess of one or more essential nutrients it may be clinically manifested or detected by biochemical ,anthropometric measurements In 2009, the World Health Organization (WHO) estimated that 20 million children under 5 years suffered from severe acute malnutrition (SAM) worldwide, which is associated to more than half of their deaths each year in developing countries.

Severe acute malnutrition is defined by a very low weight for height ( below -3z scores of the median WHO growth standards ,by visible severe wasting or by presence of nutritional edema It diminishes immune function and prevents the host from mounting an adequate protective response to infectious agents. In turn, infections alter nutrient status and can create a deficiency state. Thus, malnutrition and infection often act synergistically to increase morbidity and mortality, particularly among infants and children The usual signs of infection are absent or nonspecific in children with acute severe malnutrition (SAM), Furthermore, laboratory diagnostic capacity is often limited in regions with the highest burdens of malnutrition.

Malnourished patients maintain the capacity to release inflammatory markers such as CRP & Interleukin-6 which can be considered favorable for combating infections.

Malnourished patients maintain the capacity to release inflammatory markers such as CRP which can be considered favorable for combating infections.

(CRP) as a diagnostic tool of infection in children by the fact that SAM, particularly edematous malnutrition, can be associated with reduced levels of acute phase proteins.

Malnutrition results in various changes in the body including changes in haematologic profile of the body. White cell changes seen in protein energy malnutrition varies and such changes have been attributed to various factors.

These include the synergist relationship which protein energy malnutrition has with infections and thymic atrophy seen in children with PEM also platlet count and function affected in SAM Various authors correlate blood platelet activation with infections and concluded that Platelet destruction occurs in infection and hypercoagulable state . Moreover, blood platelet has immunological functions and participate in the interaction between pathogens and host defenses . Other studies revealed that some platelets functions (ADP and collagen - induced platelets aggregations) have been decreased in protein energy malnutrition .

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients who are included with inclusion criteria

Description

Inclusion Criteria:

- All children aged 6 months up to 5 years who were admitted with the diagnosis of SAM .

The diagnosis of SAM was made using the recent WHO criteria measuring weight for length/height and mid-upper arm circumference (MUAC) and the presence of bilateral pitting oedema and severe wasting. Two forms of SAM exist in children: nonoedematous malnutrition, also known as marasmus, characterized by severe wasting and currently defined by weight for length/height z score < -3 of the WHO growth standard, or MUAC <11.5 cm; and edematious malnutrition defined by bilateral pitting edema also known as Kwashiorkor.10 The term marasmic kwashiorkor, has been used to describe children with both wasting and edema.

Exclusion Criteria:

  • 1. Children below 6 months or above 5 years 2. Children with mild and moderate malnutrition, 3. Children with malnutrition secondary to serious underlying conditions including

    • Congenital anomalies, inborn errors of metabolism, malignancies, inherited autosomal disorders like cystic fibrosis, chronic diarrhial diseases like coeliac disease,
    • Congenital cardiac diseases, chronic kidney disease were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlate between inflammatory markers and cbc indices in severly malnourished children
Time Frame: baseline

to determine whether children with SAM can mount an acute phase reactant response namely CRP and to evaluate the usefulness of quantitative CRP as a predictor of severe infections in children with SAM.

And to correlate between inflammatory markers and CBC indices (mainly WBCS and platelets in those children .
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 24, 2020

First Submitted That Met QC Criteria

October 24, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • infection in malnutrition

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Response

Clinical Trials on CBC _inflammatory markers _ platelet function test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe