Clinical Trials Logo

Clinical Trial Summary

Severe acute malnutrition (SAM) is a life threatening condition and is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 World Health Organization (WHO) growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. SAM results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children. Children with complicated SAM require inpatient treatment in specialized centers. The "Rehabilitation and Nutritional Education Center" (CREN) is a specialized center in Burkina Faso receiving on average 10 SAM children per day. Recovery rate is lower than international standards; and adverse events and mortality remain strikingly high. The main objective of this study is to assess the underlying risk factors affecting the effectiveness of the nutritional therapeutic treatment protocol for complicated SAM children under 5 years of age who have been referred to the CREN, at the Centre Hôspitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso. The specific objective of this study is 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05009823
Study type Observational
Source University Ghent
Contact
Status Completed
Phase
Start date August 10, 2021
Completion date August 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT03360877 - Prevention of Nosocomial Infections (CleanKids) N/A
Completed NCT04715204 - Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100 N/A
Not yet recruiting NCT06061484 - Modified Dosage for Severe Acute Malnutrition N/A
Not yet recruiting NCT06038071 - Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC) N/A
Completed NCT03666572 - Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition Phase 2
Completed NCT05015257 - Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor. N/A
Completed NCT05020847 - Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM N/A
Recruiting NCT06123390 - Evaluating RISQ System Implementation in Acutely Malnourished Children in Chad (CRIMSON) N/A
Completed NCT03370003 - Non-routine Use of Antibiotics (Amoxi-light)
Completed NCT03303131 - SAM: Discharge Based on the Use of a MUAC-based Criterion to N/A
Recruiting NCT06002438 - Eggs for Gut Health N/A
Terminated NCT05473234 - Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria Phase 3
Completed NCT01613547 - The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications N/A
Completed NCT01331044 - Ready to Use Therapeutic Food (RUTF) in Severe Malnourished Children N/A
Completed NCT03094247 - Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development N/A
Recruiting NCT04240990 - Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition N/A
Completed NCT01958905 - Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children N/A
Completed NCT05737472 - High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting N/A
Completed NCT03716115 - Therapeutic Approaches to Malnutrition Enteropathy Phase 2
Completed NCT01593969 - A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition Phase 2