The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela. The main question it aims to answer is: What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ \<-2 or mid-upper-arm circumference (MUAC) \<125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery. Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.
Age range
6 Months – 59 Months
Sex
ALL
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Recovery rate
Timeframe: From date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Weight gain
Timeframe: From date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Mid-Upper Arm Circumference (MUAC) gain
Timeframe: From date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Duration of the treatment
Timeframe: From date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Prevalence of child morbidity
Timeframe: From date of enrolment until the date of recovery, last documented progression or date of death from any cause, whichever came first.
Number of RUTF delivered per child
Timeframe: From date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Cost per child
Timeframe: From date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first