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

NCT03400930 | Completed

• 1 other identifier: 1061/15
• Study Type: observational
• Target: 473
• Locations: 3 countries
• Sites: 3

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:

• 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:
• possible misdiagnosis of SAM made by MUAC or WHZ criteria,
• varying degree of severity and need for admission to treatment of the different types of diagnosis,
• 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.

Conditions

Severe Acute Malnutrition

Keywords

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (6)

• Leptin

  Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin.

  At admission

• Stable Isotope Analysis (SIA)

  Describe and compare the different types of SAM anthropometric diagnoses based on Stable Isotope Analysis (SIA)

  At admission

• Clinical Signs

  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.

  At admission

• Micronutrient status

  Describe and compare the different types of SAM anthropometric diagnoses based on micronutrient status.

  At admission

• Bioelectric impedance (BI)

  Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance (BI).

  At admission

• Patient's health and nutritional status (caretaker's perception)

  Describe and compare the different types of SAM anthropometric diagnoses based on the caretaker's perception of the patient's health and nutritional status.

  At admission

Secondary Outcomes (17)

• Stable Isotope Analysis (SIA)

  At 2 weeks, 4 weeks, 6 weeks & 8 after admission.

• Clinical signs: dehydration

  At 2 weeks & 8 weeks after admission.

• Clinical signs: visible wasting

  At 2 weeks & 8 weeks after admission.

• Clinical signs: pulse

  At 2 weeks & 8 weeks after admission.

• Clinical signs: micronutrient deficiency

  At 2 weeks & 8 weeks after admission.

Other Outcomes (3)

• Socio-economic index

  At 3 weeks after admission.

• Household food insecurity access scale (HFIAS)

  At 1 weeks after admission.

• Individual Dietary Diversity Score (IDDS)

  At 2 weeks, 4 weeks, 6 weeks & 8 after admission.

Study Arms (3)

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

Interventions

Severe Acute Malnutrition OTHER

OptiDiag-Cohort, Liberia; OptiDiag-cohort, Bangladesh; OptiDiag/MANGO-Cohort, Burkina Faso

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).
• Caretakers consent for the child to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Action Contre la Faim: lead
• Duke University: collaborator
• University Ghent: collaborator
• AgroParisTech: collaborator
• University College, London: collaborator
• Humanitarian Innovation Fund: collaborator
• European Commission: collaborator

Study Sites (3)

Action Against Hunger, Bangladesh

Cox’s Bāzār, Chittagong, 4700, Bangladesh

Location

Action Contre la Faim, Burkina Faso

Fada N'gourma, Région de l'Est, Burkina Faso

Location

Action Against Hunger, Liberia

Monrovia, Montserrado County, 1000, Liberia

Location

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MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Patrick Kolsteren, MD, PhD

  UGent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: January 17, 2018
• Study Start: January 1, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1); BA (1); BU (1)