protocolSection identificationModule nctId: NCT06287827, orgStudyIdInfo id: 190224, briefTitle: Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: UNICEF - Venezuela, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Malnutrition in Childhood, conditions: Wasting, conditions: Child Malnutrition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Simplified protocol, interventions name: Standard protocol, outcomesModule primaryOutcomes measure: Recovery rate, primaryOutcomes measure: Weight gain, primaryOutcomes measure: Mid-Upper Arm Circumference (MUAC) gain, primaryOutcomes measure: Duration of the treatment, primaryOutcomes measure: Prevalence of child morbidity, primaryOutcomes measure: Number of RUTF delivered per child, primaryOutcomes measure: Cost per child, secondaryOutcomes measure: Prevalence of child stunting, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Bolivar State Centers, status: RECRUITING, city: Puerto Ordaz, state: Bolivar, zip: 8050, country: Venezuela, contacts name: Mary Lares, PhD, role: CONTACT, phone: +584166203588, email: marylares@hotmail.com, contacts name: Mary Lares, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.29829, lon: -62.72198, locations facility: Ditrict Capital centers, status: RECRUITING, city: Caracas, state: Capital District, zip: 1090, country: Venezuela, contacts name: Pablo Hernandez, MSc, role: CONTACT, phone: +584142561345, email: doctuscumliber@gmail.com, contacts name: Pablo Hernandez, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 10.48801, lon: -66.87919, locations facility: Miranda State Centers, status: RECRUITING, city: Santa Lucia, state: Miranda, zip: 1214, country: Venezuela, contacts name: Pablo Hernandez, MSc, role: CONTACT, phone: +584142561345, email: doctuscumliber@gmail.com, contacts name: Pablo Hernandez, MSc, role: PRINCIPAL_INVESTIGATOR, locations facility: La Guaira State Centers, status: RECRUITING, city: La Guaira, zip: 1160, country: Venezuela, contacts name: Claret Mata, MSc, role: CONTACT, phone: +584142052498, email: clujaym@gmail.com, contacts name: Claret Mata, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 10.59901, lon: -66.9346, hasResults: False