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

NCT04698070 | Completed DMC

• 1 other identifier: 35237
• Study Type: interventional
• Target: 2,304
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Malnutrition in Infancy (Disorder)

Keywords

Acute malnutrition; Randomized Clinical Trial; Child Malnutrition; Severe acute malnutrition; Moderate acute malnutrition; Niger; Sub-Saharan Africa; MUAC

Outcome Measures

Primary Outcomes (1)

• Success rate

  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.

  6-month after randomisation

Secondary Outcomes (2)

• Recovery rate in children with SAM WHO definition

  Throughout the 6-month observation period

• Recovery rate in children with MUAC<115mm

  Throughout the 6-month observation period

Other Outcomes (9)

• Assess the cost-effectiveness of OptiMA and ComPAS strategies compared to the national protocol of acute malnutrition treatment in Niger

  At 6 month

• Outpatient recovery rate

  Throughout the 16-weeks outpatient follow up.

• Consumption of RUTF

  At the visit of recovery status occuring through the 6 month study completion

Study Arms (3)

Standard

ACTIVE COMPARATOR

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.

Other: National nutritional Strategy (Niger)

OptiMA

EXPERIMENTAL

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.

Dietary Supplement: Nutritional Strategy - OptiMA

ComPAS

EXPERIMENTAL

RUTF 1000 kcal/d for children with nutritional edema or MUAC \< 115 mm and 500 kcal/day for MUAC 115-124 mm.

Dietary Supplement: Nutritional Strategy - ComPAS

Interventions

Nutritional Strategy - OptiMA DIETARY_SUPPLEMENT

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).

OptiMA

Nutritional Strategy - ComPAS DIETARY_SUPPLEMENT

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.

ComPAS

National nutritional Strategy (Niger) OTHER

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).

Standard

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alliance for International Medical Action: lead
• Harvard School of Public Health (HSPH): collaborator
• University of Bordeaux: collaborator

Study Sites (4)

Diney

Mirriah, Zinder Region, Niger

Location

Droum

Mirriah, Zinder Region, Niger

Location

Gada

Mirriah, Zinder Region, Niger

Location

Gaffati

Mirriah, Zinder Region, Niger

Location

Related Publications (1)

• Daures M, Hien J, Phelan K, Boubacar H, Atte S, Aboubacar M, Aly AAGM, Mayoum B, Azani JC, Koffi JJ, Seri B, Beuscart A, Gabillard D, Hubert V, Cazes C, Kinda M, Anglaret X, Kangas S, Shepherd S, Becquet R. Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger. Trials. 2022 Jan 28;23(1):89. doi: 10.1186/s13063-021-05955-6.

  PMID: 35090531 DERIVED

Related Links

• Description ALIMA website

MeSH Terms

Conditions

Child Nutrition Disorders; Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition

Study Officials

• Susan Shepherd, MD

  Alliance for International Medical Action

  PRINCIPAL INVESTIGATOR

• Renaud Becquet, MPH,PhD,HDR

  Inserm U1219 Bordeaux Population Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: January 6, 2021
• Study Start: March 22, 2021
• Primary Completion: March 22, 2022
• Study Completion: June 24, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: SAP : before end of the study on ClinicalTrials.gov Individual participant data : Beginning 6 months and ending 36 months following article publication. After 36 months the data will be available in our University's data warehouse
• Access Criteria: Study Protocol and ICF(both in french) can be shared on request Individual participant data : researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee

Locations

NI (4)