Clinical trial NCT06287827: Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research
Official title: Evaluation of the Treatment of Moderate and Severe Acute Malnutrition in Outpatient Care Services in Venezuela: a Multicentric and Prospective Cohort Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: UNICEF - Venezuela
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 299
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recovery rate
timeFrame: 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
measure: Weight gain
timeFrame: 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
measure: Mid-Upper Arm Circumference (MUAC) gain
timeFrame: 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
measure: Duration of the treatment
timeFrame: 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
measure: Prevalence of child morbidity
timeFrame: From date of enrolment until the date of recovery, last documented progression or date of death from any cause, whichever came first.
measure: Number of RUTF delivered per child
timeFrame: 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
measure: Cost per child
timeFrame: 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:
measure: Prevalence of child stunting
timeFrame: At the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Other outcomes:
Locations:
city: Puerto Ordaz
country: Venezuela
facility: Bolivar State Centers
state: Bolivar
city: Caracas
country: Venezuela
facility: Ditrict Capital centers
state: Capital District
city: Santa Lucia
country: Venezuela
facility: Miranda State Centers
state: Miranda
city: La Guaira
country: Venezuela
facility: La Guaira State Centers
Study officials:
affiliation: Nutri Consult
name: Pablo Hernandez, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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 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.
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 Malnutrition. Curr Dev Nutr. 2021 Feb 2;5(2):nzab007. doi: 10.1093/cdn/nzab007. eCollection 2021 Feb.
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 Oct;11(4):859-69. doi: 10.1111/mcn.12192. Epub 2015 Apr 7.
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 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.
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 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.
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/s13063-018-2594-7.
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(1):251. doi: 10.1186/s13063-018-2643-2.