Dietary Rehabilitation in Severely Acutely Malnourished Children

NCT05009823 | Completed

• 1 other identifier: BC-09443
• Study Type: observational
• Target: 1,959
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Severe Acute Malnutrition; Kwashiorkor; Nutritional Edema; Marasmus

Keywords

Severe acute malnutrition; Nutritional rehabilitation; F75; F100; Ready to use therapeutic food (RUTF); Stabilization phase; Transition phase; Kwashiorkor; Marasmus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Anorexia

  Through study completion, an average of 15 days

• Mortality

  Through study completion, an average of 15 days

• Diarrhea

  Through study completion, an average of 15 days

• Vomiting

  Through study completion, an average of 15 days

• Adherence to the dietary treatment

  Through study completion, an average of 15 days

Other Outcomes (7)

• HIV/AIDS

  Through study completion, an average of 15 days

• Hepatitis

  Through study completion, an average of 15 days

• Tuberculosis

  Through study completion, an average of 15 days

Study Arms (2)

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; Dietary Supplement: Alternative F75 With CMV; Dietary Supplement: Alternative F75 Without CMV

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; Dietary Supplement: Standard F75 + RUTF; Dietary Supplement: Alternative F75 with CMV + RUTF; Dietary Supplement: Alternative F75 without CMV + RUTF

Interventions

Standard F75 DIETARY_SUPPLEMENT

F-75 contains 75 kcal and 0.9 g protein per 100 ml.

Stabilization phase

Alternative F75 With CMV DIETARY_SUPPLEMENT

Cereal flour, oil, sugar, powdered milk with complex mineral-vitamin.

Stabilization phase

Alternative F75 Without CMV DIETARY_SUPPLEMENT

Cereal flour, oil, sugar, powdered milk without complex mineral-vitamin.

Stabilization phase

F100 DIETARY_SUPPLEMENT

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)

Transition phase

Standard F75 + RUTF DIETARY_SUPPLEMENT

Standard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive

Transition phase

Alternative F75 with CMV + RUTF DIETARY_SUPPLEMENT

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

Transition phase

Alternative F75 without CMV + RUTF DIETARY_SUPPLEMENT

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

Transition phase

Eligibility Criteria

• Age: 0 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator
• University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso): collaborator
• Centre Muraz: collaborator

Study Sites (1)

Centre Hospitalier Universitaire Souro

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (4)

• 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.

  PMID: 32060161 BACKGROUND

• 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.

  PMID: 24606092 BACKGROUND

• 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.

  PMID: 12764489 BACKGROUND

• 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.

  PMID: 25937927 BACKGROUND

Related 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

MeSH Terms

Conditions

Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Protein Deficiency; Deficiency Diseases

Study Officials

• Stefaan De Henauw, Md. PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Souheila Abbeddou, MSc. PhD

  University 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 18, 2021
• Study Start: August 10, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)