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

September 30, 2024 updated by: UNICEF - Venezuela

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Venezuela
      • La Guaira, Venezuela, 1160
        • La Guaira State Centers
    • Bolivar
      • Puerto Ordaz, Bolivar, Venezuela, 8050
        • Bolivar State Centers
    • Capital District
      • Caracas, Capital District, Venezuela, 1090
        • Ditrict Capital centers
    • Miranda
      • Santa Lucia, Miranda, Venezuela, 1214
        • Miranda State Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Simplified protocol

The first cohort will be composed of all children between 6 and 59 months of age who attend predefined outpatient care points in the states Distrito Capital, Miranda, and La Guaira. These children must meet the inclusion criteria for the research. For those selected in these centers, the method of nutritional treatment for acute malnutrition will be the simplified protocol. Adaptations in this protocol include:

  1. Use of a single treatment product (Ready to use therapeutic food).
  2. Reduced dose.
  3. Expanded cut-offs.
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).
Standard protocol
The second cohort will be composed of all children between 6 and 59 months of age who attend other predefined outpatient care points in the four states and met the inclusion criteria for this research. Nutritional treatment will be administered to these children, following the WHO Standard Protocol.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery rate
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
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.
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
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
Average weight change in each protocol.
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
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
Average Mid-Upper Arm Circumference (MUAC) change in each protocol.
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
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
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
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
Time Frame: From date of enrolment until the date of recovery, last documented progression or date of death from any cause, whichever came first.
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
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
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
Average number of RUTF delivered per child (SAM/MAM) in each protocol
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
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
Average number of dollars that cost to recovery a child in each cohort
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of child stunting
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
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
At the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICEF - Venezuela

Investigators

  • Principal Investigator: Pablo Hernandez, MSc, Nutri Consult

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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