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

Child Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287827
• Other study ID #: 190224
• Status: Recruiting
• Start date: February 14, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: UNICEF - Venezuela
• Contact: Pablo Hernandez, MSc
• Phone: +584142561345
• Email: doctuscumliber[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Child Malnutrition
• Child Nutrition Disorders
• Malnutrition
• Severe Acute Malnutrition
• Wasting

Intervention

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
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.

Locations

Country	Name	City	State
Venezuela	Ditrict Capital centers	Caracas	Capital District
Venezuela	La Guaira State Centers	La Guaira
Venezuela	Bolivar State Centers	Puerto Ordaz	Bolivar
Venezuela	Miranda State Centers	Santa Lucia	Miranda

Sponsors (1)

Lead Sponsor	Collaborator
UNICEF - Venezuela

Country where clinical trial is conducted

Venezuela, 

References & Publications (10)

Alvarez Moran JL, Ale GBF, Charle P, Sessions N, Doumbia S, Guerrero S. The effectiveness of treatment for Severe Acute Malnutrition (SAM) delivered by community health workers compared to a traditional facility based model. BMC Health Serv Res. 2018 Mar 27;18(1):207. doi: 10.1186/s12913-018-2987-z. — View Citation

Bahwere P. Severe acute malnutrition during emergencies: burden management, and gaps. Food Nutr Bull. 2014 Jun;35(2 Suppl):S47-51. doi: 10.1177/15648265140352S107. — View Citation

Bailey J, Lelijveld N, Marron B, Onyoo P, Ho LS, Manary M, Briend A, Opondo C, Kerac M. Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial. Trials. 2018 Apr 24;19( — View Citation

Bailey J, Opondo C, Lelijveld N, Marron B, Onyo P, Musyoki EN, Adongo SW, Manary M, Briend A, Kerac M. A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled — View Citation

Daures M, Phelan K, Issoufou M, Kouanda S, Sawadogo O, Issaley K, Cazes C, Seri B, Ouaro B, Akpakpo B, Mendiboure V, Shepherd S, Becquet R. New approach to simplifying and optimising acute malnutrition treatment in children aged 6-59 months: the OptiMA si — View Citation

Hussain I, Habib A, Ariff S, Khan GN, Rizvi A, Channar S, Hussain A, Fazal S, Kumar D, Alvarez JL, Guerrero S, Grant A, Soofi SB. Effectiveness of management of severe acute malnutrition (SAM) through community health workers as compared to a traditional — View Citation

James PT, Van den Briel N, Rozet A, Israel AD, Fenn B, Navarro-Colorado C. Low-dose RUTF protocol and improved service delivery lead to good programme outcomes in the treatment of uncomplicated SAM: a programme report from Myanmar. Matern Child Nutr. 2015 — View Citation

Lelijveld N, Bailey J, Mayberry A, Trenouth L, N'Diaye DS, Haghparast-Bidgoli H, Puett C. The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation. Trials. 2018 Apr 24;19(1):252. doi: 10.1186/s13063-01 — View Citation

Maust A, Koroma AS, Abla C, Molokwu N, Ryan KN, Singh L, Manary MJ. Severe and Moderate Acute Malnutrition Can Be Successfully Managed with an Integrated Protocol in Sierra Leone. J Nutr. 2015 Nov;145(11):2604-9. doi: 10.3945/jn.115.214957. Epub 2015 Sep 30. — View Citation

Stephenson KB, Agapova SE, Hendrixson DT, Koroma AS, Manary MJ. An Optimized Dose of Therapeutic Feeding Results in Noninferior Growth in Midupper Arm Circumference Compared with a Standard Dose in Children in Sierra Leone Recovering from Acute Malnutriti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	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
Primary	Weight gain	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
Primary	Mid-Upper Arm Circumference (MUAC) gain	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
Primary	Duration of the treatment	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
Primary	Prevalence of child morbidity	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.
Primary	Number of RUTF delivered per child	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
Primary	Cost per child	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	Prevalence of child stunting	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