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

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.

Conditions

• Severe Acute Malnutrition

Interventions

OTHER

Severe Acute Malnutrition

Sponsors & Collaborators

• Duke University

  collaborator OTHER

• University Ghent

  collaborator OTHER

• AgroParisTech

  collaborator OTHER

• University College, London

  collaborator OTHER

• Humanitarian Innovation Fund

  collaborator UNKNOWN

• European Commission

  collaborator OTHER

• Action Contre la Faim

  lead OTHER

Principal Investigators

• Patrick Kolsteren, MD, PhD · UGent

Eligibility

Min Age

6 Months

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2018-04-25

Completion

2018-04-25

Countries

• Bangladesh
• Burkina Faso
• Liberia

Study Locations