NCT04608643

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

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

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

October 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 16, 2021

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

October 24, 2020

Last Update Submit

August 13, 2021

Conditions

Inflammatory Response

Keywords

inflammatory markers in severly malnourished children

Outcome Measures

Primary Outcomes (1)

  • 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 .

    baseline

Interventions

CBC _inflammatory markers _ platelet function testDIAGNOSTIC_TEST

CBC , Erythrocte sedimentation rate (ESR) ,CRP, platlet functions tests ( adhesions, 'aggregations ristocetin).

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all patients who are included with inclusion criteria

You may qualify if:

  • \- 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Calder PC, Jackson AA. Undernutrition, infection and immune function. Nutr Res Rev. 2000 Jun;13(1):3-29. doi: 10.1079/095442200108728981.

    PMID: 19087431BACKGROUND

  • Chisti 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.

    PMID: 19772545BACKGROUND

  • Page 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.

    PMID: 23874731BACKGROUND

  • Delgado 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.

    PMID: 18568246BACKGROUND

  • Jahoor 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.

    PMID: 18510818BACKGROUND

  • Speth 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.

    PMID: 24199802BACKGROUND

Related Links

Central Study Contacts

meret michael, doctor

CONTACT

01024189397meretmichael@gmail.com

emad el daly, professor

CONTACT

01223559943emadeldeen.ail@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 24, 2020

First Posted

October 29, 2020

Study Start

September 1, 2021

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

August 16, 2021

Record last verified: 2020-10