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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03400930
• Date of registration: 21/03/2017
• Prospective Registration: No
• Primary sponsor: Action Contre la Faim
• Public title: 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
• Scientific 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
• Date of first enrolment: January 1, 2017
• Target sample size: 473
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03400930
• Study type: Observational

Countries of recruitment

Bangladesh, Burkina Faso, Liberia

Contacts

• Name: Patrick Kolsteren, MD, PhD
• Affiliation: UGent

Key inclusion & exclusion 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.



Age minimum: 6 Months
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

Severe Acute Malnutrition

Intervention(s)

Other: Severe Acute Malnutrition

Primary Outcome(s)

Clinical Signs [Time Frame: At admission]

Bioelectric impedance (BI) [Time Frame: At admission]

Stable Isotope Analysis (SIA) [Time Frame: At admission]

Micronutrient status [Time Frame: At admission]

Patient's health and nutritional status (caretaker's perception) [Time Frame: At admission]

Leptin [Time Frame: At admission]

Secondary Outcome(s)

Micronutrient status [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: dehydration [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: acute respiratory infection [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: temperature [Time Frame: At 2 weeks & 8 weeks after admission.]

Early weight gain [Time Frame: After 2 weeks and 4 weeks after admission.]

Bioelectric impedance (BI) [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: micronutrient deficiency [Time Frame: At 2 weeks & 8 weeks after admission.]

Leptin [Time Frame: At 2 weeks & 8 weeks after admission.]

Patient's health and nutritional status (caretaker's perception) [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: dermatosis [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: diarrhea [Time Frame: At 2 weeks & 8 weeks after admission.]

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).]

Clinical signs: hair changes [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: visible wasting [Time Frame: At 2 weeks & 8 weeks after admission.]

Stable Isotope Analysis (SIA) [Time Frame: At 2 weeks, 4 weeks, 6 weeks & 8 after admission.]

Clinical signs: respiratory rate [Time Frame: At 2 weeks & 8 weeks after admission.]

Clinical signs: pulse [Time Frame: At 2 weeks & 8 weeks after admission.]

Secondary ID(s)

1061/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke University

University College, London

European Commission's Directorate-General for European Civil Protection and Humanitarian Aid Operations

Humanitarian Innovation Fund

AgroParisTech

University Ghent