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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

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General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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