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

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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Simplified protocol cohort  MUAC <125 mm or Weight-Height/length Z Score <-2 or Mild bipedal pitting oedema.  And all the following:  No medical complications  Positive appetite test.  Standard protocol cohort  SAM:  MUAC <115 mm or Weight-Height/length Z Score <-3 or Mild bipedal pitting oedema  And all the following:  No medical complications Positive appetite test  MAM (Although MAM cases are not traditionally included, in this study they will be incorporated if they meet the following criteria):  MUAC ≥ 115 mm to < 125 mm or Weight-Height/length Z Score ≥ -3 to < -2 and No nutritional oedema  And at least one the following:  Failing to recover from moderate wasting after receiving other interventions (counselling alone). Having relapsed to moderate wasting History of severe wasting Households' low socioeconomic status (Determined by Graffar-Mendez-Castellanos method) Co-morbidity (HIV, tuberculosis, or a physical or mental disability that does not jeopardize the anthropometric measurements)  Exclusion Criteria:  Both cohorts:  Congenital malformations that make anthropometric measurements impossible. Family that intends to leave the study area before four months. Presence of medical condition requiring referral for hospitalization. Presence of medical condition requiring referral for hospitalization. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 59 Months - StdAgeList: Child - StudyPopulation: The research population consisted of children with uncomplicated moderate or severe acute malnutrition who are admitted to the nutritional care program in care centers and associated institutions in Bolívar, Capital District, La Guaira, and Miranda.  Given the observational nature of the research, the sample size of the population will not be calculated. Rather, a research group or intentional sample will be analyzed, made up of all children who attend the care centers and meet the inclusion criteria of the research during a collection period of two months in each cohort. - SamplingMethod: Non-Probability Sample