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

NACompletedINTERVENTIONAL
Enrollment

2,304

Participants

Timeline

Start Date

March 22, 2021

Primary Completion Date

March 22, 2022

Study Completion Date

June 24, 2022

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)."

Trial Locations (4)

Unknown

Diney, Mirriah

Droum, Mirriah

Gada, Mirriah

Gaffati, Mirriah

All Listed Sponsors
collaborator

Harvard School of Public Health (HSPH)

OTHER

collaborator

University of Bordeaux

OTHER

lead

Alliance for International Medical Action

OTHER

NCT04698070 - Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Niger (OptIMA Niger) | Biotech Hunter | Biotech Hunter