Evaluation of the Treatment of Moderate and Severe Acute Malnutrition in Outpatient Care Services in Venezuela: a Multicentric and Prospective Cohort Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 4
- 主要终点
- Mid-Upper Arm Circumference (MUAC) gain
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- •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.
结局指标
主要结局
Mid-Upper Arm Circumference (MUAC) gain
时间窗: 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
Average Mid-Upper Arm Circumference (MUAC) change in each protocol.
Prevalence of child morbidity
时间窗: From date of enrolment until the date of recovery, last documented progression or date of death from any cause, whichever came first.
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
Duration of the treatment
时间窗: 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
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
Weight gain
时间窗: 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
Average weight change in each protocol.
Recovery rate
时间窗: 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
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.
Number of RUTF delivered per child
时间窗: 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
Average number of RUTF delivered per child (SAM/MAM) in each protocol
Cost per child
时间窗: 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
Average number of dollars that cost to recovery a child in each cohort
次要结局
- 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)