Clinical trial NCT05009823: Dietary Rehabilitation in Severely Acutely Malnourished Children
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso)
name: Centre Muraz
First posted: 2021-08-18
Enrollment: 1959
Sex: ALL
Minimum age (years): 0
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of days during the first phase of treatment
timeFrame: Three to Seven days
measure: Number of days during the transition phase of treatment
timeFrame: Three to Five days
measure: Daily weight gain during the first phase of treatment
timeFrame: Three to Seven days
measure: Daily weight gain during the transition phase
timeFrame: Three to Five days
measure: Edema redevelopment during the transition phase
timeFrame: Three to Five days
Secondary outcomes:
measure: Anorexia
timeFrame: Through study completion, an average of 15 days
measure: Mortality
timeFrame: Through study completion, an average of 15 days
measure: Diarrhea
timeFrame: Through study completion, an average of 15 days
measure: Vomiting
timeFrame: Through study completion, an average of 15 days
measure: Adherence to the dietary treatment
timeFrame: Through study completion, an average of 15 days
Other outcomes:
measure: HIV/AIDS
timeFrame: Through study completion, an average of 15 days
measure: Hepatitis
timeFrame: Through study completion, an average of 15 days
measure: Tuberculosis
timeFrame: Through study completion, an average of 15 days
measure: Tumoral pathologies (benign or malignant)
timeFrame: Through study completion, an average of 15 days
measure: Malformative pathologies
timeFrame: Through study completion, an average of 15 days
measure: Diabetes
timeFrame: Through study completion, an average of 15 days
measure: Renal failure.
timeFrame: Through study completion, an average of 15 days
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: Centre Hospitalier Universitaire Souro
Study officials:
affiliation: University Ghent
name: Stefaan De Henauw, Md. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Souheila Abbeddou, MSc. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: Jerome Some, Md. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.
name: Bintou Sanogo, MSc. Md.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.