Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research
NCT ID: NCT06287827
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
299 participants
OBSERVATIONAL
2024-02-14
2024-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
59 Months
ALL
No
Sponsors
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UNICEF - Venezuela
OTHER
Responsible Party
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Principal Investigators
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Pablo Hernandez, MSc
Role: PRINCIPAL_INVESTIGATOR
Nutri Consult
Locations
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Bolivar State Centers
Puerto Ordaz and San Felix, Bolívar, Venezuela
Ditrict Capital centers
Caracas, Distrito Federal, Venezuela
Miranda State Centers
Santa Lucía, Miranda, Venezuela
La Guaira State Centers
La Guaira, , Venezuela
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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190224
Identifier Type: -
Identifier Source: org_study_id
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