Dietary Rehabilitation in Severely Acutely Malnourished Children
Condition: Severe Acute Malnutrition; Kwashiorkor; Nutritional Edema; Marasmus
MeSH terms: Malnutrition; Severe Acute Malnutrition; Kwashiorkor; Protein-Energy Malnutrition
Study type: Observational

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.
    

Intervention name(s): Standard F75; Alternative F75 With CMV; Alternative F75 Without CMV; F100; Standard F75 + RUTF; Alternative F75 with CMV + RUTF; Alternative F75 without CMV + RUTF
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): F-75 contains 75 kcal and 0.9 g protein per 100 ml.; Cereal flour, oil, sugar, powdered milk with complex mineral-vitamin.; Cereal flour, oil, sugar, powdered milk without complex mineral-vitamin.; 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); Standard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive; 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; 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
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.
      
Keywords: Severe acute malnutrition; Nutritional rehabilitation; F75; F100; Ready to use therapeutic food (RUTF); Stabilization phase; Transition phase; Kwashiorkor; Marasmus