Evaluation of Two Optimizing and Simplifying Strategies on Acute Malnutrition Treatment in Children Aged 6 to 59 Months in Mirriah District, Zinder, Niger
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 2,304
- Locations
- 4
- Primary Endpoint
- Success rate
Study Overview
Brief Summary
Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Such separation complicates delivery of care, contributes to poor program performance, and creates confusion among caregivers. Reduction in the mortality burden from AM will stem from improved simplicity, efficiency and cost-effectiveness of current protocols.
Eligibility for SAM treatment in the current Niger protocol is complex. It is determined by 3 independent criteria: nutritional oedema, Mid-Upper Arm Circumference (MUAC) < 115 mm or weight-height Z score (WHZ) <-3. Also, the Ready to Use Therapeutic Food (RUTF) ration in Niger protocol (130-200 kcal/kg/d) is paradoxical. The amount of RUTF prescribed in the first weeks of treatment is often less than what given to child reaching recovery (MUAC > 125 and WHZ >-2), because weekly ration is determined by the child's weight. Rate of weight gain is highest in the first two weeks of treatment, then plateaus - suggesting no benefit of increased RUTF ration at the end of treatment. Progressive reduction is a more rational use of RUTF and this supplement is equally effective for SAM and MAM.
This community-based non-inferiority trial will compare two strategies for the treatment of AM to the Niger protocol for SAM and MAM. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy uses MUAC < 125 mm or nutritional oedema as admission criteria and optimizes RUTF by adapting doses to the degree of malnutrition. RUTF dose for MUAC < 115 mm or oedema is 170 kcal/kg/d and progressively reduces to 75 kcal/kg/d as MUAC increases. The Combined Protocol for Acute Malnutrition Study (ComPAS) uses the same eligibility criteria like OptiMA, but simplifies more the RUTF ration by providing 1000 kcal/d for children with oedema or MUAC < 115 mm and 500 kg/d for children with MUAC 115-124 mm. Children are considered recovered if they have 2 consecutive weekly MUAC measures ≥ 125 mm.
Children will be individually randomized to treatment in one of the 3 study arms and will attend clinic visits weekly until nutritional recovery. After discharged, they will be monitored monthly via a nurse-conducted home visits until 6 months post-inclusion. The trial arms will be compared using a composite outcome indicator that includes vital status, anthropometric measures and relapse following the index AM episode.
The hypothesis is that simplified strategies could substantially increase the number of children in care compared to current SAM programs without requiring additional RUTF or staffing while maintaining recovery rates in line with current programs.
Detailed Description
The main outcome, the success rate, is defined by a composite of three endpoints : alive, not acutely malnourished per the definition applied at inclusion and not having an additional episode of AM throughout the 6- month observation period. All other children are classified as 'unsuccessful'.
The secondary major outcome, the recovery rate, is defined by reaching during the 6 month follow-up a MUAC>=125 and no oedema during two consecutive weeks, a minimum RUTF treatment period of 4 weeks and good clinical condition.
Sample size:
For the main objective, the expected success rate is 68% with a statistical power of 90%. For the secondary priority objective n°1, the expected recovery rate is 82% and for the secondary priority objective n°2, the expected recovery rate is 74% with a statistical power of 80%. For all objectives, the margin of non-inferiority set is 10% with a level of significance set at 1.25% unilaterally. An inflation of 5% to account for unexploitable data was also added. The number of randomized subjects required is:
- 568 participants to meet the main objective;
- 295 participants with severe acute malnutrition to meet the secondary priority objective n°1.
- 384 participants with MUAC<115mm at admission to meet the secondary priority objective n°2.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 59 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 6 to 59 months old upon study inclusion
- •Meet one of the acute malnutrition criteria defined as follows:
- •MUAC < 125mm or
- •Weight for Length Z-score <-3 (WHO standard) or
- •Oedema grade + or ++;
- •Resident in health area where the study is conducted ;
- •Child's mother or guardian provides informed consent.
Exclusion Criteria
- •Children with medical condition requiring hospitalization or negative appetite test or oedema grade +++;
- •Children allergic to milk, peanuts and/or RUTFs ;
- •Children diagnosed with a chronic pathology such as sickle cell anemia, trisomy 21, congenital heart disease, neurological condition;
- •Children currently enrolled in another malnutrition programme.
Arms & Interventions
Standard
RUTF 130-200 kcal/kg/day for children with nutritional edema or MUAC < 115 mm or WHZ <-3 and RUSF 500 kcal/d for children 6-23 months with WHZ between -2 and -3 Z and MUAC 115-124 mm.
Intervention: National nutritional Strategy (Niger) (Other)
OptiMA
RUTF 170 kcal/kg/d for children with nutritional edema or MUAC < 115 mm; 125 kcal/kg/d for MUAC 115-119 mm and 75 kcal/kg/d for MUAC 120-124 mm.
Intervention: Nutritional Strategy - OptiMA (Dietary Supplement)
ComPAS
RUTF 1000 kcal/d for children with nutritional edema or MUAC < 115 mm and 500 kcal/day for MUAC 115-124 mm.
Intervention: Nutritional Strategy - ComPAS (Dietary Supplement)
Outcomes
Primary Outcomes
Success rate
Time Frame: 6-month after randomisation
The primary outcome is a binary composite indicator. Children classified as 'success' fulfil all of the following criteria: alive, not acutely malnourished per the definition applied at inclusion and no additional episode of acute malnutrition (inclusion criteria) throughout the 6-month observation period. All other children are classified unsuccessful.
Secondary Outcomes
- Recovery rate in children with MUAC<115mm(Throughout the 6-month observation period)
- Recovery rate in children with SAM WHO definition(Throughout the 6-month observation period)