NCT06287827

Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research

Evaluation of the Treatment of Moderate and Severe Acute Malnutrition in Outpatient Care Services in Venezuela: a Multicentric and Prospective Cohort Research

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 299 (actual)
• Sponsor: UNICEF - Venezuela · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Malnutrition in Childhood
• Wasting
• Child Malnutrition

Interventions

Type	Name	Description
PROCEDURE	Simplified protocol	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).
PROCEDURE	Standard protocol	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.

Timeline

• Start date: 2024-02-14
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-03-01
• Last updated: 2024-10-02

Locations

4 sites across 1 country: Venezuela