Inflammatory ResponseNCT04608643
Inflammatory Markers and Cbc Indices in Severely Malnourished Children
An observational study of Inflammatory Response, run by Assiut University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- CBC _inflammatory markers _ platelet function test
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2022
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: all patients who are included with inclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Inflammatory Response
- Being tested
- CBC _inflammatory markers _ platelet function test
- Keywords
- inflammatory markers in severly malnourished children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC _inflammatory markers _ platelet function testDiagnostic test
CBC , Erythrocte sedimentation rate (ESR) ,CRP, platlet functions tests ( adhesions, 'aggregations ristocetin).
What is being measured
The primary outcome is the main question the study is designed to answer.
correlate between inflammatory markers and cbc indices in severly malnourished children
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 .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study startSep 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meret Michael Fahmy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608643
- Sponsor's protocol ID
- infection in malnutrition
- Status last verified
- Oct 2020
- First submitted
- 24 Oct 2020
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Calder PC, Jackson AA. Undernutrition, infection and immune function. Nutr Res Rev. 2000 Jun;13(1):3-29. doi: 10.1079/095442200108728981.
PubMed 19087431Chisti MJ, Tebruegge M, La Vincente S, Graham SM, Duke T. Pneumonia in severely malnourished children in developing countries - mortality risk, aetiology and validity of WHO clinical signs: a systematic review. Trop Med Int Health. 2009 Oct;14(10):1173-89. doi: 10.1111/j.1365-3156.2009.02364.x.
PubMed 19772545Page AL, de Rekeneire N, Sayadi S, Aberrane S, Janssens AC, Rieux C, Djibo A, Manuguerra JC, Ducou-le-Pointe H, Grais RF, Schaefer M, Guerin PJ, Baron E. Infections in children admitted with complicated severe acute malnutrition in Niger. PLoS One. 2013 Jul 17;8(7):e68699. doi: 10.1371/journal.pone.0068699. Print 2013.
PubMed 23874731Delgado AF, Okay TS, Leone C, Nichols B, Del Negro GM, Vaz FA. Hospital malnutrition and inflammatory response in critically ill children and adolescents admitted to a tertiary intensive care unit. Clinics (Sao Paulo). 2008 Jun;63(3):357-62. doi: 10.1590/s1807-59322008000300012.
PubMed 18568246Jahoor F, Badaloo A, Reid M, Forrester T. Protein metabolism in severe childhood malnutrition. Ann Trop Paediatr. 2008 Jun;28(2):87-101. doi: 10.1179/146532808X302107.
PubMed 18510818Speth C, Loffler J, Krappmann S, Lass-Florl C, Rambach G. Platelets as immune cells in infectious diseases. Future Microbiol. 2013 Nov;8(11):1431-51. doi: 10.2217/fmb.13.104.
PubMed 24199802
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Inflammatory Markers and Complete Blood Film Indices (White Blood Cells and Platelets ) in Severely Malnourished Children
- ClinicalTrials.gov ID
- NCT04608643
- Acronym / sponsor ID
- infection in malnutrition
- Conditions
- Inflammatory Response
- Keywords
- inflammatory markers in severly malnourished children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Oct 2020 (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.
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 .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all patients who are included with inclusion criteria
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC _inflammatory markers _ platelet function testCBC , Erythrocte sedimentation rate (ESR) ,CRP, platlet functions tests ( adhesions, 'aggregations ristocetin). | Diagnostic test | – |
Primary outcome
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Background: PubMed 19087431Calder PC, Jackson AA. Undernutrition, infection and immune function. Nutr Res Rev. 2000 Jun;13(1):3-29. doi: 10.1079/095442200108728981.
- Background: PubMed 19772545Chisti MJ, Tebruegge M, La Vincente S, Graham SM, Duke T. Pneumonia in severely malnourished children in developing countries - mortality risk, aetiology and validity of WHO clinical signs: a systematic review. Trop Med Int Health. 2009 Oct;14(10):1173-89. doi: 10.1111/j.1365-3156.2009.02364.x.
- Background: PubMed 23874731Page AL, de Rekeneire N, Sayadi S, Aberrane S, Janssens AC, Rieux C, Djibo A, Manuguerra JC, Ducou-le-Pointe H, Grais RF, Schaefer M, Guerin PJ, Baron E. Infections in children admitted with complicated severe acute malnutrition in Niger. PLoS One. 2013 Jul 17;8(7):e68699. doi: 10.1371/journal.pone.0068699. Print 2013.
- Background: PubMed 18568246Delgado AF, Okay TS, Leone C, Nichols B, Del Negro GM, Vaz FA. Hospital malnutrition and inflammatory response in critically ill children and adolescents admitted to a tertiary intensive care unit. Clinics (Sao Paulo). 2008 Jun;63(3):357-62. doi: 10.1590/s1807-59322008000300012.
- Background: PubMed 18510818Jahoor F, Badaloo A, Reid M, Forrester T. Protein metabolism in severe childhood malnutrition. Ann Trop Paediatr. 2008 Jun;28(2):87-101. doi: 10.1179/146532808X302107.
- Background: PubMed 24199802Speth C, Loffler J, Krappmann S, Lass-Florl C, Rambach G. Platelets as immune cells in infectious diseases. Future Microbiol. 2013 Nov;8(11):1431-51. doi: 10.2217/fmb.13.104.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response, 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 3 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 16 Aug 2021. 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 meret michael, doctor (01024189397, meretmichael@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlate between inflammatory markers and cbc indices in severly malnourished children (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608643, which also lists 6 linked publications.
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 16 Aug 2021.