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Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond (OptiDiag)

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ClinicalTrials.gov Identifier: NCT03400930
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Duke University
University Ghent
AgroParisTech
University College, London
Humanitarian Innovation Fund
European Commission's Directorate-General for European Civil Protection and Humanitarian Aid Operations
Information provided by (Responsible Party):
Action Contre la Faim

Brief Summary:

INTRODUCTION

In 2014, 50 million children under 5 suffered from acute malnutrition, of which 16 million suffered from SAM, most of them living in sub-Saharan Africa and Southeast Asia. SAM children have higher risk of mortality (relative risk between 5 and 20). It is an underlying factor in over 50% of the 10 - 11 million preventable deaths per year among children under five. At present, 65 countries have implemented WHO recommendations for SAM treatment (both in-patient for complicated cases and outpatient for uncomplicated cases) but these programs have very low coverage, reaching only around 10 - 15 % of SAM children.

In 2009 the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) issued a joint statement in an effort to harmonize the application of anthropometric criteria for SAM diagnosis and monitoring in child aged 6 - 59 months; the statement presents recommended cut-offs, and summarizes the rational for the adoption, of the following two anthropometric criteria:

  1. Weight-for-Height Z-Score (WHZ): "WHO and UNICEF recommend the use of a cut-off for weight-for-height of below -3 standard deviations (SD) of the WHO standards to identify infants and children as having SAM." Additionally, analysis of existing data show that children with a WHZ < -3 have a highly elevated risk of death.
  2. Mid-Upper Arm Circumference (MUAC): "WHO standards for the MUAC-for-age show that in a well-nourished population there are very few children aged 6 - 59 months with a MUAC less than 115 mm. Children with a MUAC less than 115 mm have a highly elevated risk of death compared to those who are above. Thus it is recommended to [use] the cut-off point [of] 115 mm to define SAM with MUAC."

GENERAL OBJECTIVE

To generate new evidence on pathophysiological process, nutritional needs and risks associated with different types of anthropometric deficits in children under 5, in order to optimize the diagnosis and treatment of SAM.

SPECIFIC OBJECTIVES

  • To compare nutritional status, metabolism, pathophysiological process and risks in different types of SAM anthropometric diagnosis, with or without concomitant stunting (growth retardation).
  • To analyze the extent to which current SAM treatment is promoting recovery and healthy growth in different categories of children.
  • To evaluate the relevance of current discharge criteria used in nutrition programs and their association with metabolic recovery, in different age groups and among those who are stunted.
  • To test novel rapid tests of emerging biomarkers predicting long-term outcomes and mortality risk in the field.

METHODOLOGY

A wide range of supplementary information related to nutritional status, body composition, metabolic and immune status, including emerging biomarkers of metabolic deprivation and vulnerability, will be collected besides anthropometry during prospective observational studies. They will be collected with minimum level of invasiveness, compatible with field work requirements in the humanitarian context.

Phase 1: Cross-sectional surveys. Phase 2: Prospective cohort studies involving SAM children between 6 months and 5 years old.

Children admitted as SAM at the nutrition centers will be enrolled into the cohort. The follow up duration will be at least three months.

EXPECTED OUTCOMES

  • Confirmation of current hypotheses related to:

    1. possible misdiagnosis of SAM made by MUAC or WHZ criteria,
    2. varying degree of severity and need for admission to treatment of the different types of diagnosis,
    3. underlying heterogeneity of the pathophysiology.
  • Generation of new algorithms for the assessment and classification of malnourished children, based on the combined use of emerging biomarkers and anthropometric measures, or on the modification of anthropometric criteria.
  • Generation of new treatment paradigms based on the predictive value of biomarkers in combination with traditional anthropometric measures. This will enable us to assess the power of current treatment regimens to promote long-term weight gain and growth and will allow us to tailor treatment to the physiological needs of the child.

Condition or disease Intervention/treatment
Severe Acute Malnutrition Other: Severe Acute Malnutrition

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OptiDiag: Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort Intervention/treatment
OptiDiag-Cohort, Liberia
A respresentative population of 275 Liberian children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).
Other: Severe Acute Malnutrition
OptiDiag/MANGO-Cohort, Burkina Faso
A respresentative population of 275 Burkinabé children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).
Other: Severe Acute Malnutrition
OptiDiag-cohort, Bangladesh
A respresentative population of 275 Bangladeshi children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).
Other: Severe Acute Malnutrition



Primary Outcome Measures :
  1. Leptin [ Time Frame: At admission ]
    Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin.

  2. Stable Isotope Analysis (SIA) [ Time Frame: At admission ]
    Describe and compare the different types of SAM anthropometric diagnoses based on Stable Isotope Analysis (SIA)

  3. Clinical Signs [ Time Frame: At admission ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs at admission; these include: dehydration, visible signs of wasting, pulse, signs of micronutrient deficiency, acute resipiratory infections, respiratory rate, temperature, dermatosis and hair changes and diarrhea.

  4. Micronutrient status [ Time Frame: At admission ]
    Describe and compare the different types of SAM anthropometric diagnoses based on micronutrient status.

  5. Bioelectric impedance (BI) [ Time Frame: At admission ]
    Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance (BI).

  6. Patient's health and nutritional status (caretaker's perception) [ Time Frame: At admission ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the caretaker's perception of the patient's health and nutritional status.


Secondary Outcome Measures :
  1. Stable Isotope Analysis (SIA) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks & 8 after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the history of lipid and protein catabolism (δ13C and δ15N isotopes in hair) reversed throughout nutritional rehabilitation.

  2. Clinical signs: dehydration [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs for dehydration at admission and the development of clinical signs of dehydration during treatment.

  3. Clinical signs: visible wasting [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of visible wasting at admission and the development of clinical signs of visible wasting during treatment.

  4. Clinical signs: pulse [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal pulse at admission and the development of abnormal pulse during treatment.

  5. Clinical signs: micronutrient deficiency [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of micronutrient deficency at admission and the development of clinical signs of micronutrient deficency during treatment.

  6. Clinical signs: acute respiratory infection [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of acute respiratory infection at admission and the development of clinical signs of acute respiratory infection during treatment.

  7. Clinical signs: respiratory rate [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal respiratory rate at admission and the development of clinical signs of abnormal respiratory rate during treatment.

  8. Clinical signs: temperature [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal temperature at admission and the development of clinical signs of abnormal temperature during treatment.

  9. Clinical signs: dermatosis [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of dermatosis at admission and the development of clinical signs of dermatosis during treatment.

  10. Clinical signs: hair changes [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of hair change (color and consistency) linked to acute malnutrition at admission and the development of clinical signs of of hair change (color and consistency) during treatment.

  11. Clinical signs: diarrhea [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the severity of diarrhea at admission and the development of diarrhea during treatment.

  12. Treatment outcomes [ Time Frame: Events occuring up to maximum treatment duration as per national protocol (up to 12 weeks in Bangladesh, up to 16 weeks in Burkina Faso, and up to 12 weeks in Liberia). ]
    Describe and compare the different types of SAM anthropometric diagnoses based on negative and positive treatment outcomes; these include: discharged from program as recovered [mid-upper arm circumference (MUAC) ≥ 125 and weight-for-height Z-score (WHZ) ≥ -2], defaulted from program (caretaker confirmation of unwillingness to participate), death, transfer to an in-patient facility (developement of medical complications as per national protocol, loss of or static weight), transfer to another out-patient facility outside of the program catchment area and facility and non-response to treatment (cure criteria unattained before maximum treatment duration).

  13. Early weight gain [ Time Frame: After 2 weeks and 4 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on early weight gain.

  14. Leptin [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin

  15. Micronutrient status [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on micronutrient status.

  16. Patient's health and nutritional status (caretaker's perception) [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on the caretaker's perception of the patient's health and nutritional status.

  17. Bioelectric impedance (BI) [ Time Frame: At 2 weeks & 8 weeks after admission. ]
    Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance.


Other Outcome Measures:
  1. Socio-economic index [ Time Frame: At 3 weeks after admission. ]
    Measures of household wealth reflected by durable assets, source of water supply, sanitation favility, type of floor material, type of cooking fuel, transportation, livestock, homestead or land area, bank account, number of family members per sleeping room.

  2. Household food insecurity access scale (HFIAS) [ Time Frame: At 1 weeks after admission. ]
    The HFIAS is composed of a set of nine questions that have been used in several countries and appear to distinguish food insecure from food secure households across different cultural contexts.

  3. Individual Dietary Diversity Score (IDDS) [ Time Frame: At 2 weeks, 4 weeks, 6 weeks & 8 after admission. ]
    Individual dietary diversity scores (IDDS) validated for age/sex groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In the effort to describe and compare nutritional needs and risks associated with the different types of anthropometric diagnoses as they are present in the community, inclusion criteria for this study are designed to create a cohort to match the population of children who will be detected and referred to treatment in the catchment areas of community-based acute malnutrition management programs.
Criteria

Inclusion Criteria:

  • Diagnosed SAM and eligible for CMAM treatment, defined as: (1) WHZ < -3 and/or MUAC < 115 mm; (2) No bilateral pitting edema; (3) Children without the general danger signs of illness as per the Integrated Management of Childhood Illness (IMCI) guidelines like lethargy, unconsciousness, convulsions or severe vomiting (WHO 2005).
  • Resident of the catchment area at the time of inclusion; and
  • Caretakers consent for the child to participate.

Exclusion Criteria:

  • Plans to leave the catchment area within the next 6 months;
  • Known peanut and/or milk allergy;
  • Admitted for SAM treatment within the past 6 months prior to recruitment (including re-admission after default, relapse or medical transfer);
  • Malformations which may affect food intake such as cleft palate, cerebral palsy, Down's syndrome; and,
  • The presence of general danger signs as per the IMCI guidelines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400930


Contacts
Contact: Trenton M Dailey-Chwalibóg, MPH, PhD Fellow +33 1 70 84 72 49 tdailey-chwalibog@actioncontrelafaim.org
Contact: Benjamin A Guesdon, MEng, PhD +33 1 70 84 73 08 bguesdon@actioncontrelafaim.org

Locations
Bangladesh
Action Against Hunger, Bangladesh Recruiting
Cox's Bazar, Chittagong, Bangladesh, 4700
Contact: Rayhan Md. Mostak, MSc, MPH    +88 01848 303052    nutpmoptidiag-cox@bd.missions-acf.org   
Burkina Faso
Action Contre la Faim, Burkina Faso Recruiting
Fada N'Gourma, Région De l'Est, Burkina Faso
Contact: Suvi Kangas, MSc, PhD Fellow    +226 77 69 97 16    rpmango-fa@bf.missions-acf.org   
Liberia
Action Against Hunger, Liberia Recruiting
Monrovia, Montserrado, Liberia, 1000
Contact: Issa A Kemokai, BSN    +231 (0)777 444 715    optidiagpm-mo@lr.missions-acf.org   
Sponsors and Collaborators
Action Contre la Faim
Duke University
University Ghent
AgroParisTech
University College, London
Humanitarian Innovation Fund
European Commission's Directorate-General for European Civil Protection and Humanitarian Aid Operations
Investigators
Principal Investigator: Patrick Kolsteren, MD, PhD UGent

Publications:
ENN, SCUK, ACF, UNHCR. Mid Upper Arm Circumference and Weight-for-Height Z-score as indicators of severe acute malnutrition: a consultation of operational agencies and academic specialists to understand the evidence, identify knowledge gaps and to inform operational guidance.
Fleming AF, de Silva PS. Haematological diseases in the tropics. In: Cook GC, Zumla AI, editors. Manson's tropical diseases. London: Saunders; 2003. pp. 169-244.
Girma T. Bioimpedance in severely malnourished children. An emerging method for monitoring hydration of children with severe acute malnutrition [dissertation]. Copenhagen: Department of Nutrition, Exercise and Sports; University of Copenhagen; 2014.
Levin HM, Pollitt E, Galloway R, McGuire J. Micronutrient deficiency disorders. In: Jamison DT, Mosley WH, Measham AR, Bobadilla JL, editors. Disease control priorities in developing countries. 2nd ed. Oxford (UK): Oxford University Press; 1993. pp. 421-451
Nemer L, Gelband H, Jha P; Commission on Macroeconomics and Health. The evidence base for interventions to reduce malnutrition in children under five and school-age children in low- and middle-income countries. CMH working paper no WG5:11. Geneva: World Health Organization; 2001
Rytter M. In-patient treatment of severe acute malnutrition - immune function, oedema and survival [dissertation]. Copenhagen: Department of Nutrition, Exercise and Sports; University of Copenhagen; 2014.

Responsible Party: Action Contre la Faim
ClinicalTrials.gov Identifier: NCT03400930     History of Changes
Other Study ID Numbers: 1061/15
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Action Contre la Faim:
Severe Acute Malnutrition

Additional relevant MeSH terms:
Malnutrition
Severe Acute Malnutrition
Nutrition Disorders