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

NCT06287827 | Completed

• 1 other identifier: 190224
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Malnutrition in Childhood; Wasting; Child Malnutrition

Keywords

Severe acute malnutrition; Moderate acute malnutrition; Ready-to-use therapeutic food; Malnutrition treatment; Venezuela; Mid-upper arm circumference; Wasting; Simplified protocol; Standard protocol

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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.

• 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

• 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 Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Simplified protocol PROCEDURE

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).

Simplified protocol

Standard protocol PROCEDURE

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.

Standard protocol

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNICEF - Venezuela: lead

Study Sites (4)

Bolivar State Centers

Puerto Ordaz and San Felix, Bolívar, 8050, Venezuela

Location

Ditrict Capital centers

Caracas, Distrito Federal, 1090, Venezuela

Location

Miranda State Centers

Santa Lucía, Miranda, 1214, Venezuela

Location

La Guaira State Centers

La Guaira, 1160, Venezuela

Location

Related 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.

  PMID: 29580238 BACKGROUND

• 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.

  PMID: 25069293 BACKGROUND

• 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.

  PMID: 26423737 BACKGROUND

• 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 non-inferiority trial in Kenya and South Sudan. PLoS Med. 2020 Jul 9;17(7):e1003192. doi: 10.1371/journal.pmed.1003192. eCollection 2020 Jul.

  PMID: 32645109 RESULT

• 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 Malnutrition. Curr Dev Nutr. 2021 Feb 2;5(2):nzab007. doi: 10.1093/cdn/nzab007. eCollection 2021 Feb.

  PMID: 33659773 RESULT

• 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 Oct;11(4):859-69. doi: 10.1111/mcn.12192. Epub 2015 Apr 7.

  PMID: 25850698 RESULT

• 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 single-arm proof-of-concept trial in Burkina Faso. Br J Nutr. 2020 Apr 14;123(7):756-767. doi: 10.1017/S0007114519003258. Epub 2019 Dec 10.

  PMID: 31818335 RESULT

• 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 facility-based model: a cluster randomized controlled trial. Eur J Nutr. 2021 Oct;60(7):3853-3860. doi: 10.1007/s00394-021-02550-y. Epub 2021 Apr 20.

  PMID: 33880645 RESULT

• 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/s13063-018-2594-7.

  PMID: 29690899 RESULT

• 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(1):251. doi: 10.1186/s13063-018-2643-2.

  PMID: 29690916 RESULT

MeSH Terms

Conditions

Cachexia; Child Nutrition Disorders; Severe Acute Malnutrition

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Nutrition Disorders; Nutritional and Metabolic Diseases; Malnutrition

Study Officials

• Pablo Hernandez, MSc

  Nutri Consult

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 1, 2024
• Study Start: February 14, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

VE (4)