Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo
Condition: Severe Acute Malnutrition; Moderate Acute Malnutrition; Child Malnutrition; Acute Malnutrition; Congo, The Democratic Republic of the; Africa; Randomized Clinical Trial
MeSH terms: Malnutrition; Severe Acute Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition
      contributes to nearly half of all child deaths each year, with the forms characterized by
      wasting or oedema (acute malnutrition) associated with the highest risk of death.

      Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe
      and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs
      overseen by different UN agencies, and using different protocols and products. Such
      separation complicates delivery of care, contributes to high default and low coverage, and
      creates confusion among caregivers. Often treatment is only available for SAM children
      resulting in lives lost and costly hospitalisation that could be averted if nutritional
      support were available earlier in the wasting process. If we are to reduce the health and
      mortality burden from malnutrition, the effectiveness and cost-effectiveness of current
      protocols need dramatic improvements.

      The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not
      changed since introduction of out-patient protocols in the mid-2000s. Children classified as
      SAM in these protocols are determined by three independent criteria: the presence of
      nutritional oedema or MUAC < 115 mm or weight-height Z score <-3. The RUTF dosage in these
      protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases
      of treatment is often less than that given as the child nears recovery, because the number of
      packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day)
      is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of
      increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a
      more rational use of RUTF.

      The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying
      management of acute malnutrition through the use of a single anthropometric admission
      criterion (mid upper arm circumference [MUAC] < 125 mm or nutritional oedema) - one that best
      captures children's anthropometry related mortality risk- and by optimizing the use of RUTF
      by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d
      for the most severely wasted (MUAC < 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema
      resolves and MUAC increases > 120 mm.

      The investigators hypothesize that this strategy could double the number of children in care
      compared to current SAM programs without substantially increasing the amount of RUTF or
      staffing required while maintaining a recovery rate in line with current programs. OptiMA may
      also improve coverage and reduce the need for hospitalization through early identification of
      malnourished children.

      The investigators propose to conduct a community-based non-inferiority clinical trial with
      individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo
      standard nutritional protocol for SAM. Study children will be randomly assigned to the
      intervention arm or control arm - with children at MUAC < 125 mm or oedema eligible for RUTF
      in the intervention arm and those meeting current WHO SAM definition eligible in the control
      group. All participants will be followed for 9 months post-randomization to assess
      non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional
      status (MUAC ≥ 125 mm and WHZ >-3, no oedema) and no relapse to acute malnutrition for those
      who were treated with RUTF. The main secondary outcome will assess the non-inferiority of
      OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to
      children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.
    

Detailed description: 
      The OptiMA strategy proposes a new malnutrition management approach, grounded in 3 main
      principles.

      Firstly, the diagnosis of acute malnutrition is refined to target those at highest mortality
      risk within the CMAM definition of acute malnutrition (WHZ < -2 or MUAC < 125 mm or oedema),
      by targeting treatment to children with a MUAC < 125 mm or oedema. The simplicity of MUAC
      measure allows families to screen children and check for oedema at home and identify
      malnourished children at an earlier stage. The diagnosis is quickly confirmed by clinicians
      at the health center. MUAC progression is also used to monitor recovery and determine
      discharge thus eliminating the discrepancies that occur when both MUAC and WHZ are used to
      diagnose acute malnutrition.

      Secondly, RUTF dosage is rationalized, and calibrated to the child's degree of wasting. The
      WHZ tables and dosing tables are replaced by a single table that determines the child's RUTF
      ration based on MUAC category and weight. Larger rations, on a per kilo basis, are given to
      the most severely malnourished and the ration is reduced as the child progresses to recovery.

      Thirdly, supply chain is simplified to a single RUTF and data management from 2 programs are
      merged into one. This streamlined programme should result in better coverage, a high
      proportion of children detected before MUAC<115 mm, lower RUTF consumption per child and
      fewer acute malnutrition related hospitalisations.
    

Intervention name(s): Nutritional Strategy - OptiMA; Effective nutritional standard strategy
Intervention type(s): Other; Other
Intervention description(s): All children with a MUAC<125mm or oedema will be treated with the same RUTF, according to a new dosage table based on the evolution of MUAC and weight during recovery (RUTF dosage prescribed is gradually reduced as weight and MUAC increase).
All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet discharge criteria, and then a bimonthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated).; Children presenting with MUAC<115 or WHZ<-3 or nutritional oedema, will be treated with RUTF, according to the usual dosage table based on weight at each visit.
All children (whether eligible for RUTF or not) will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). Children not eligible for RUTF at randomization will benefit from this same monthly community-based follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 parallel arms stratified on site and degree of acute malnutrition. 890 participants for the principal objective 480 participants with severe acute malnutrition for the secondary main objective
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Malnutrition; Severe Acute Malnutrition; Moderate Acute Malnutrition; Child Malnutrition; Congo, The Democratic Republic of the; Randomized Clinical Trial; Africa