Stopped: The sponsoring organization UNICEF-Venezuela with administrative control over the study decided to terminate it.
Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ \<-2 or MUAC \<125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Recovery rate
Timeframe: Up to 4 months, 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
Weight gain
Timeframe: Up to 4 months, 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
MUAC gain
Timeframe: Up to 4 months, 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
Duration of the treatment
Timeframe: Up to 4 months, 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
Prevalence of relapse after discharge from the treatment
Timeframe: at six months after the admission
Number of RUTF delivered per child
Timeframe: Up to 4 months, 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
Cost per child
Timeframe: Up to 4 months, 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