Completed

The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso

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What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Severe Acute Malnutrition+5

+ Deficiency Diseases

+ Kwashiorkor

Until 59 Months
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: August 2021
See protocol details

Summary

Principal SponsorUniversity Ghent
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 10, 2021

Actual date on which the first participant was enrolled.

Severe acute malnutrition (SAM), defined as severe wasting \[weight-to-height Z-score < -3 standard deviations (SD), based on the WHO Child Growth Standards\] and / or the presence of nutritional edema, and / or mid-upper arm circumference (MUAC) <115 mm, is a condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. Management of SAM children without complications is provided at the community level. Hospitalization in specialized care centers is necessary for SAM children with complications. SAM children with comorbidities have a greater risk of mortality and treatment failure. The knowledge of the specific adequate nutritional needs of SAM is limited. For the treatment of SAM in hospital, the WHO recommends the use of therapeutic milk low in protein 'F75' in the stabilization phase; and more protein-rich F100 or F75 combined with ready-to-use therapeutic foods (RUTF) in the transition phase. The WHO also recommends using as an alternative formula made of cereal flour, skimmed milk powder, oil, sugar, and a therapeutic vitamin and mineral complex (CMV), in case of shortage of the standard therapeutic milk F75 / F100 or in case of signs of intolerance (vomiting, diarrhea). The Refeeding Center - Centre de Récupération et d'Education Nutritionnelle (CREN) of the Sourô Sanou University Hospital Center (CHUSS) in Burkina Faso specializes in the care of SAM children with complications. In 2018, out of 500 children aged 6-59 months admitted for SAM with complications, the CHUSS CREN registered 86.8% full recovery, 8.2% dropout and 5% death. Although the recovery rate is higher than international standards (greater than 75%), the mortality rate remains higher than the recommended 3% by international standards; in addition to the challenges that are faced locally in maintaining high standards of care. At the CREN, the investigators and the nurses observed that some SAM children with complications can have severe diarrhea and vomiting after taking F75 (first phase of the nutritional treatment). It was also observed that other SAM children with edema, whose edema resolved in the first phase of treatment under F75, redeveloped edema when they received RUTF (Plumpy Nut®) in the transition phase according to the WHO 2013 protocol. This research project, which will be subdivided into a retrospective study and two prospective clinical trials aims to assess the risk factors affecting the response to dietary treatment in this center (the CREN, Burkina Faso) and to compare alternatives for treatment during the nutritional rehabilitation. The retrospective study assesses the factors of failure of dietary treatment in the three phases of nutritional rehabilitation to better understand underlying risk factors associated with a lower recovery rate and high mortality in complicated SAM children referred to CREN for inpatient care. Risk factors associated with poor response to a standard dietary treatment at any phase will be assessed retrospectively and include: 1. Errors in the treatment (feeding) dosage that can be due to errors in anthropometric measurement and/or in reading the feeding regimen table by the CREN team; 2. Low adherence of children to the therapeutic dietary regimen 3. Comorbidities associated with malnutrition that can have an effect on the dietary treatment effectiveness 4. Types of dietary regimen selected during the first phase of treatment \[F75 vs. alternative F75 (cereal flour, oil, sugar, powdered milk) with OR without CMV)\] and during the transition phase \[F75 + RUTF ( Plumpy-Nut®), F100, alternative F75 (with and without CMV) + RUTF (Plumpy Nut®)\]. The study will use data collected during admission and follow-up of SAM children with complications admitted at the CREN of the CHUSS from January 2014 to December 2018.

Official TitleThe Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso
NCT05009823
Principal SponsorUniversity Ghent
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1959 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 59 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Severe Acute MalnutritionDeficiency DiseasesKwashiorkorNutrition DisordersNutritional and Metabolic DiseasesProtein DeficiencyProtein-Energy MalnutritionMalnutrition

Criteria

4 inclusion criteria required to participate
Severe acute malnutrition defined as Weight-for-Height Z-score (WHZ) <- 3 SD AND / OR MUAC <115 mm AND / OR with edema

With complications

Who were admitted and treated in the refeeding center (CREN) of the CHUSS from January 2014 TO December 2018

Aged between 0 and 59 Months

2 exclusion criteria prevent from participating
Older than 59 Months

Moderate Acute Malnutrition (MAM)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Centre Hospitalier Universitaire Souro

Bobo-Dioulasso, Burkina FasoOpen Centre Hospitalier Universitaire Souro in Google Maps
CompletedOne Study Center