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.
The general objective of the 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 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in outpatient care services in the states Bolívar, Capital District, La Guaira, and Miranda of Venezuela. This will be a multicentric and prospective cohort study assessing the Simplified Protocol with the Standard Protocol, among children with uncomplicated acute malnutrition. Children will be prospectively followed until their recovery or for a maximum of 16 weeks. The study will be implemented in 4 Venezuelan states chosen based on their acute malnutrition prevalence and operational constraints. The protocol will be implemented by health professionals from each institution, duly previously trained in applying the study protocol.
Study Type
OBSERVATIONAL
Enrollment
299
MUAC-based dosing: * SAM \[MUAC \<115mm or WHZ \<-3 or oedema (+/++)\] = Two 92g sachets Ready to use Therapeutic Food (RUTF)/day (Approx. 1000 kcal/day). * MAM \[MUAC 115mm\<125mm or WHZ \<-2\] = One 92g sachet RUTF/day (Approx. 500 kcal/day).
Weight-based dosing * SAM: Mid-upper-arm circumference (MUAC) \<115mm or Weight-Height/length Z Score \<-3 or mild or moderate bipedal oedema: 150-185 kcal/kg/day is offered using RUTF until the patient passes to MAM and then the dose is reduced to 100 -130 kcal/kg/day using RUTF until recovery. * MAM: MUAC 115-\<125mm or Weight-Height/length Z Score \<-2: 100-130 kcal/kg/day is offered using RUTF until recovery.
Bolivar State Centers
Puerto Ordaz and San Felix, Bolívar, Venezuela
Ditrict Capital centers
Caracas, Distrito Federal, Venezuela
Miranda State Centers
Santa Lucía, Miranda, Venezuela
La Guaira State Centers
La Guaira, Venezuela
Recovery rate
This indicator is defined as the number of children who recovered from SAM and MAM (WHZ\>-2 and MUAC\>=125mm and the absence of bilateral edema for two consecutive visits, within 16 weeks of enrollment in the program, divided by the total number of treated children.
Time frame: 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
Average weight change in each protocol.
Time frame: 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
Average Mid-Upper Arm Circumference (MUAC) change in each protocol.
Time frame: 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
Defined as the average number of weeks spent on treatment (enrollment and recovery) in children 6-59 months of age at enrollment, according to health registers
Time frame: 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
Defined by the number of days with symptoms of acute respiratory infections, fever, diarrhea (three or more loose or liquid stools per day) and malaria divided by the total number of days observed/reported in the recall period
Time frame: 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
Average number of RUTF delivered per child (SAM/MAM) in each protocol
Time frame: 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
Average number of dollars that cost to recovery a child in each cohort
Time frame: 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 stunting
Proportion of children with Height-for-age Z-score (LAZ)\<-2 (according to the 2006 World Health Organization reference) at the end of the study
Time frame: At the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.