Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287827
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Brief Title:
Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela a Prospective Cohort Research
Sponsor:
UNICEF - Venezuela
Organization:
UNICEF - Venezuela
Study Overview
Official Title:
Evaluation of the Treatment of Moderate and Severe Acute Malnutrition in Outpatient Care Services in Venezuela a Multicentric and Prospective Cohort Research
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None