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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04698070
Recruitment Status : Completed
First Posted : January 6, 2021
Last Update Posted : September 23, 2022
Sponsor:
Collaborators:
Harvard School of Public Health (HSPH)
University of Bordeaux, INSERM, Bordeaux Population Health
Information provided by (Responsible Party):
Alliance for International Medical Action

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.


Condition or disease Intervention/treatment Phase
Acute Malnutrition in Infancy (Disorder) Dietary Supplement: Nutritional Strategy - OptiMA Dietary Supplement: Nutritional Strategy - ComPAS Other: National nutritional Strategy (Niger) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Two Optimizing and Simplifying Strategies on Acute Malnutrition Treatment in Children Aged 6 to 59 Months in Mirriah District, Zinder, Niger
Actual Study Start Date : March 22, 2021
Actual Primary Completion Date : March 22, 2022
Actual Study Completion Date : June 24, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: 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.
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).


Experimental: 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.
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).


Experimental: ComPAS
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Recovery rate in children with SAM WHO definition [ Time Frame: Throughout the 6-month observation period ]
    The secondary priority outcome n°1 is the recovery rate in participants with severe acute malnutrition (WHO definition)defined as follows: absence of bipedal oedema and MUAC > 125 mm during two consecutive weeks, a 4-week minimum duration of treatment as clinically well, i.e. axillary temperature <37.5°C. This outcome will be measured throughout the 6-month observation period. All children reaching these criteria during outpatient treatment our during the home visit will be defined recovered.

  2. Recovery rate in children with MUAC<115mm [ Time Frame: Throughout the 6-month observation period ]
    The secondary priority outcome n°2 is the recovery rate in participants with MUAC<115mm defined as follows: absence of bipedal oedema and MUAC > 125 mm during two consecutive weeks, a 4-week minimum duration of treatment as clinically well, i.e. axillary temperature <37.5°C. This outcome will be measured throughout the 6-month observation period. All children reaching these criteria during outpatient treatment our during the home visit will be defined recovered.


Other Outcome Measures:
  1. Assess the cost-effectiveness of OptiMA and ComPAS strategies compared to the national protocol of acute malnutrition treatment in Niger [ Time Frame: At 6 month ]
    The ICER (Incremental cost-effectiveness Ratio) will be estimated in each arm.

  2. Outpatient recovery rate [ Time Frame: Throughout the 16-weeks outpatient follow up. ]
    Recovery rate defined as follows: as follows: absence of bipedal oedema and MUAC > 125 mm during two consecutive weeks, a 4-week minimum duration of treatment as clinically well, i.e. axillary temperature <37.5°C will be estimated at the end of the outpatient follow up.

  3. Consumption of RUTF [ Time Frame: At the visit of recovery status occuring through the 6 month study completion ]
    The average number of RUTF sachets per child recovered and per child successfully treated

  4. Recovered children by RUTF quantity [ Time Frame: At the visit of recovery status occuring through the 6 month study completion ]
    The average number of successful and cured children for a given amount of RUTF.

  5. Relapse rate to a new episode of AM and to a new episode of SAM [ Time Frame: Throughout the 6-month observation period ]
    Comparison of the proportion of children who relapse to a new episode of AM and to a new episode of SAM in SAM children at inclusion and in children with AM at inclusion between each arms and risk factors analysis.

  6. Non-response rate [ Time Frame: At 16 weeks after inclusion ]
    Comparison of the proportion of non response (children who did not recovered after 16 weeks under supplementation) in each arms and risk factors analysis.

  7. Recovery rate of children without supplementation [ Time Frame: Throughout the 6-month observation period ]
    Describe the recovery of children not receiving nutritional supplementation with RUTF when included in the standard protocol.

  8. Recovery rate of WaST children [ Time Frame: Throughout the 6-month observation period ]
    Comparison of the recovery rate of children with acute malnutrition associated with severe or moderate stunting in each arms.

  9. Hospitalisation rate [ Time Frame: Throughout the 6-month observation period ]
    Comparaison of the hospitalisation rate in children with AM at inclusion between both arms in each population



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698070


Locations
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Niger
Diney
Mirriah, Zinder, Niger
Droum
Mirriah, Zinder, Niger
Gada
Mirriah, Zinder, Niger
Gaffati
Mirriah, Zinder, Niger
Sponsors and Collaborators
Alliance for International Medical Action
Harvard School of Public Health (HSPH)
University of Bordeaux, INSERM, Bordeaux Population Health
Investigators
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Principal Investigator: Susan Shepherd, MD Alliance for International Medical Action
Principal Investigator: Renaud Becquet, MPH,PhD,HDR Inserm U1219 Bordeaux Population Health Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alliance for International Medical Action
ClinicalTrials.gov Identifier: NCT04698070    
Other Study ID Numbers: 35237
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: September 23, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The research findings will be disseminated in peer-reviewed journals, meetings and international conferences.

Individual participant data will be accessible through controlled access repositories, after deidentification (text, tables, figures, and appendices).

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alliance for International Medical Action:
Acute malnutrition
Randomized Clinical Trial
Child Malnutrition
Severe acute malnutrition
Moderate acute malnutrition
Niger
Sub-Saharan Africa
MUAC
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders