Dietary Rehabilitation in Severely Acutely Malnourished Children

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Malnutrition; Kwashiorkor; Marasmus; Nutritional Edema
• Intervention / Treatment: Dietary supplement: Standard F75; Dietary supplement: Alternative F75 With CMV; Dietary supplement: Alternative F75 Without CMV; Dietary supplement: F100; Dietary supplement: Standard F75 + RUTF; Dietary supplement: Alternative F75 with CMV + RUTF; Dietary supplement: Alternative F75 without CMV + RUTF

Detailed 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 Type: Observational
• Enrollment (Actual): 1959

Contacts and Locations

Study Locations

• Burkina Faso
  • Bobo Dioulasso, Burkina Faso
    • Centre Hospitalier Universitaire Souro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants are children 0-59 Months of age who were hospitalized in the pediatric department for SAM with or without edema, and children hospitalized in other departments from CHUSS and received at CREN for treatment of SAM.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Older than 59 Months
• Moderate Acute Malnutrition (MAM)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stabilization phase; The dietetic treatment is given by the nurses every 2 hours on the first day; then if tolerance is good, every 3 hours the following days. No family meals during the stabilization phase. But the baby can breastfeed. A child will receive an antibiotic as per the national protocol, malaria treatment if diagnosed with malaria, Vitamin A if symptomatic eye damage, Folic acid in case of anemia, antifungal in case of candidiasis.	Dietary supplement: Standard F75; F-75 contains 75 kcal and 0.9 g protein per 100 ml.; Dietary supplement: Alternative F75 With CMV; Cereal flour, oil, sugar, powdered milk with complex mineral-vitamin.; Dietary supplement: Alternative F75 Without CMV; Cereal flour, oil, sugar, powdered milk without complex mineral-vitamin.
Transition phase; The child is assigned to one the therapeutic regimen depending on the treatment received during the stabilization phase and the results of the appetite test.	Dietary supplement: F100; 100 kcal and 3 g protein per 100 ml if the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut); Dietary supplement: Standard F75 + RUTF; Standard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive; Dietary supplement: Alternative F75 with CMV + RUTF; Alternative F75 + CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 + CMV during the stabilization phase; Dietary supplement: Alternative F75 without CMV + RUTF; Alternative F75 - CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 - CMV during the stabilization phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days during the first phase of treatment	Average number of days spent in the stabilization phase in Days	Three to Seven days
Number of days during the transition phase of treatment	Average number of days spent in the transition phase in Days	Three to Five days
Daily weight gain during the first phase of treatment	Average daily weight gain in the stabilization phase in Grams	Three to Seven days
Daily weight gain during the transition phase	Average daily weight gain in the transition phase in Grams	Three to Five days
Edema redevelopment during the transition phase	Edema redevelopment during the transition phase after starting to resolve during the stabilizing phase.	Three to Five days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anorexia	Serious severe event that occurs at anytime during the treatment	Through study completion, an average of 15 days
Mortality	Serious severe event that occurs at anytime during the treatment	Through study completion, an average of 15 days
Diarrhea	Serious severe event that occurs at anytime during the treatment	Through study completion, an average of 15 days
Vomiting	Serious severe event that occurs at anytime during the treatment	Through study completion, an average of 15 days
Adherence to the dietary treatment	Daily intake of the administered dietary treatment	Through study completion, an average of 15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV/AIDS	Detection of HIV/AIDS using polymerase chain reaction (PCR) in infants and children younger than 18 months or retroviral serology test in older children	Through study completion, an average of 15 days
Hepatitis	Test of hepatitis	Through study completion, an average of 15 days
Tuberculosis	Test of tuberculosis	Through study completion, an average of 15 days
Tumoral pathologies (benign or malignant)	Clinical diagnosis	Through study completion, an average of 15 days
Malformative pathologies	Clinical diagnosis	Through study completion, an average of 15 days
Diabetes	Clinical diagnosis	Through study completion, an average of 15 days
Renal failure.	Clinical diagnosis	Through study completion, an average of 15 days

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso; Centre Muraz; University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso)
• Investigators: Principal Investigator: Stefaan De Henauw, Md. PhD, University of Ghent; Principal Investigator: Souheila Abbeddou, MSc. PhD, University of Ghent; Principal Investigator: Jerome Some, Md. PhD, Institut de Recherche en Sciences de la Sante, Burkina Faso; Principal Investigator: Bintou Sanogo, MSc. Md., Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.

Publications and helpful links

General Publications

• Bartz S, Mody A, Hornik C, Bain J, Muehlbauer M, Kiyimba T, Kiboneka E, Stevens R, Bartlett J, St Peter JV, Newgard CB, Freemark M. Severe acute malnutrition in childhood: hormonal and metabolic status at presentation, response to treatment, and predictors of mortality. J Clin Endocrinol Metab. 2014 Jun;99(6):2128-37. doi: 10.1210/jc.2013-4018. Epub 2014 Feb 27.
• Baraki AG, Akalu TY, Wolde HF, Takele WW, Mamo WN, Derseh B, Desyibelew HD, Dadi AF. Time to recovery from severe acute malnutrition and its predictors: a multicentre retrospective follow-up study in Amhara region, north-west Ethiopia. BMJ Open. 2020 Feb 13;10(2):e034583. doi: 10.1136/bmjopen-2019-034583.
• Deen JL, Funk M, Guevara VC, Saloojee H, Doe JY, Palmer A, Weber MW. Implementation of WHO guidelines on management of severe malnutrition in hospitals in Africa. Bull World Health Organ. 2003;81(4):237-43. Epub 2003 May 16.
• Munthali T, Jacobs C, Sitali L, Dambe R, Michelo C. Mortality and morbidity patterns in under-five children with severe acute malnutrition (SAM) in Zambia: a five-year retrospective review of hospital-based records (2009-2013). Arch Public Health. 2015 May 1;73(1):23. doi: 10.1186/s13690-015-0072-1. eCollection 2015.

Helpful Links

• World Health Organization (2013) WHO guideline: updates on the management of severe acute malnutrition in infants and children.
• Enquête Nutritionnelle Nationale SMART 2016 au Burkina Faso. 2016 ; 47p.
• 10. Ministère de la Sante au Burkina Faso. Protocol National : Prise en charge intégrée de la malnutrition aigüe (PCIMA). 2014

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Severe acute malnutrition; Ready to use therapeutic food (RUTF); Nutritional rehabilitation; F75; F100; Stabilization phase; Transition phase; Kwashiorkor; Marasmus
• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Protein Deficiency; Malnutrition; Severe Acute Malnutrition; Protein-Energy Malnutrition; Kwashiorkor
• Other Study ID Numbers: BC-09443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No