Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Niger (OptIMA Niger)

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.

Conditions

• Acute Malnutrition in Infancy (Disorder)

Interventions

DIETARY_SUPPLEMENT

Nutritional Strategy - OptiMA

All children randomized to this arm will be treated with a RUTF, with weekly ration determined according to MUAC, weight and presence of nutritional edema. Ration will be adjusted weekly according to the change in MUAC and weight throughout the outpatient follow-up until the child achieves nutritional recovery. RUTF dosage will 170 kcal/kg/d for the most severely wasted (MUAC \< 115 mm or edema) and reduced to 125 kcal/kg/d for children with MUAC 115-119mm and 75 kcal/kg/d for children with MUAC 120-124 mm. All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet nutritional recovery criteria, and then a monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition). Referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected).

DIETARY_SUPPLEMENT

Nutritional Strategy - ComPAS

All children randomized to this arm will be treated with RUTF, with weekly ration determined according to MUAC and presence of nutritional edema. Children enrolled with MUAC \< 115 mm or edema will receive 1000 kcal/d (2 sachets/day) RUTF until MUAC has surpassed 115 mm and/or edema is resolved for 2 weeks at which time ration will be reduced to 500 kcal/d (1 sachet/day) until MUAC \> or = to 125 mm is achieved for 2 consecutive weeks. Children enrolled with MUAC 115-124 mm will receive 1 sachet/day until MUAC \> or = 125 mm is achieved for 2 consecutive weeks and clinically well. Following nutritional recovery, a study nurse will conduct monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition) with referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected) for the remainder of the 6 month period following inclusion.

OTHER

National nutritional Strategy (Niger)

Different protocols for SAM and MAM comprise the Niger National Nutrition Protocol: 1. SAM: Children with MUAC\<115 or WHZ\<-3 or nutritional edema, will be treated with RUTF, according to a dosage table based on weight at each visit. 2. MAM: Children aged between 6-24 months with MUAC between 115 -124 mm and WHZ\>-3 will be treated with RUSF. Children with the same anthropometry but age 24-59 m will only receive supplementation if they develop criteria for SAM during the 6 month study period. They will be monitored via monthly home visits by a study nurse. All children 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).

Sponsors & Collaborators

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• University of Bordeaux

  collaborator OTHER

• Alliance for International Medical Action

  lead OTHER

Principal Investigators

• Susan Shepherd, MD · Alliance for International Medical Action

• Renaud Becquet, MPH,PhD,HDR · Inserm U1219 Bordeaux Population Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-22

Primary Completion

2022-03-22

Completion

2022-06-24

Countries

• Niger

Study Locations