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

Completed

• Conditions: Wasting; Acute Malnutrition in Childhood; Child Malnutrition
• Interventions: Procedure: Standard protocol; Procedure: Simplified protocol

• Registration Number: NCT06287827
• Lead Sponsor: UNICEF - Venezuela

Brief 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.

Study Timeline

• Study Start: 2024-02-14
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard protocol	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.
Simplified protocol	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.

Primary Outcome Measures

Name	Time	Method
Mid-Upper Arm Circumference (MUAC) gain	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.
Prevalence of child morbidity	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
Duration of the treatment	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
Weight gain	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.
Recovery rate	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.
Number of RUTF delivered per child	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
Cost per child	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

Secondary Outcome Measures

Name	Time	Method
Prevalence of child stunting	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

Trial Locations

Locations (4)

Bolivar State Centers; 🇻🇪 Puerto Ordaz, Bolivar, Venezuela

Ditrict Capital centers; 🇻🇪 Caracas, Capital District, Venezuela

Miranda State Centers; 🇻🇪 Santa Lucia, Miranda, Venezuela

La Guaira State Centers; 🇻🇪 La Guaira, Venezuela