AzTrials
AzTrials

Acute Malnutrition in ChildhoodNCT06287827

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

An observational study of Acute Malnutrition in Childhood and Wasting, run by UNICEF - Venezuela at 4 sites in Venezuela.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 6 to 59 months
What is being tested?
Simplified protocol and Standard protocol
Type of treatment
Surgery or procedure
How many people
299 participants
Where
4 sitesVenezuela
Study dates
14 Feb 2024to 31 Aug 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 59 months
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • 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
Show all 25Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

Venezuela4 sites

  • Ditrict Capital centers

    Caracas, Distrito Federal, 1090

  • La Guaira State Centers

    La Guaira, 1160

  • Bolivar State Centers

    Puerto Ordaz and San Felix, Bolívar, 8050

  • Miranda State Centers

    Santa Lucía, Miranda, 1214

Other trials in Venezuela

About this study

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

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:

Read more

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.

Read the 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.

Being tested
Simplified protocol, Standard protocol
Keywords
Severe acute malnutrition, Moderate acute malnutrition, Ready-to-use therapeutic food, Malnutrition treatment, Venezuela, Mid-upper arm circumference, Wasting, Simplified protocol, Standard protocol
Medical subject headings
Cachexia, Child Nutrition Disorders, Severe Acute Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simplified protocolProcedure or surgery

    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 protocolProcedure or surgery

    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.
Study groups in NCT06287827
Study groupRoleWhat they receive
Simplified protocolThe 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.
Receives: Procedure: Simplified protocol
Standard protocolThe 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.
Receives: Procedure: Standard protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. Weight gain

    Average weight change in each protocol.

    Measured: 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

  3. Mid-Upper Arm Circumference (MUAC) gain

    Average Mid-Upper Arm Circumference (MUAC) change in each protocol.

    Measured: 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

  4. 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

    Measured: 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

  5. 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

    Measured: From date of enrolment until the date of recovery, last documented progression or date of death from any cause, whichever came first.

  6. Number of RUTF delivered per child

    Average number of RUTF delivered per child (SAM/MAM) in each protocol

    Measured: 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

  7. Cost per child

    Average number of dollars that cost to recovery a child in each cohort

    Measured: 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)

  1. 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

    Measured: At the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2024
  2. Study start14 Feb 2024
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06287827
Sponsor's protocol ID
190224
Status last verified
Sep 2024
First submitted
19 Feb 2024
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29580238

  • 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.

    PubMed 25069293

  • 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.

    PubMed 26423737

  • 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.

    PubMed 32645109

  • 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.

    PubMed 33659773

  • 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.

    PubMed 25850698

  • 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.

    PubMed 31818335

  • 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.

    PubMed 33880645

  • 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.

    PubMed 29690899

  • 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.

    PubMed 29690916

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Malnutrition in Childhood and Wasting, run by UNICEF - Venezuela at 4 sites in Venezuela.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery rate (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06287827, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in