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

NCT06287827 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 299

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

  • Acute Malnutrition in Childhood
  • Wasting
  • Child Malnutrition

Interventions

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.

Sponsors & Collaborators

  • UNICEF - Venezuela

    lead OTHER

Principal Investigators

  • Pablo Hernandez, MSc · Nutri Consult

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287827 on ClinicalTrials.gov