An observational study in Acute Malnutrition in Childhood, Wasting and Child Malnutrition, sponsored by UNICEF - Venezuela. Completed at 4 sites in Venezuela. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by UNICEF - Venezuela · Observational
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 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.
331 studies on the registry are indexed under Cachexia; 75 are open to participants now.
This study's enrollment of 299 is above the median of 150 across 88 observational studies indexed under Cachexia.
Browse Cachexia studies →UNICEF - Venezuela is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Simplified protocol cohort
And all the following:
Positive appetite test.
SAM:
And all the following:
MAM (Although MAM cases are not traditionally included, in this study they will be incorporated if they meet the following criteria):
And at least one the following:
Exclusion Criteria:
Both cohorts:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Simplified 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.
Procedure: Standard 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).
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.
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.
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
Weight gain
Average weight change in each protocol.
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
Mid-Upper Arm Circumference (MUAC) gain
Average Mid-Upper Arm Circumference (MUAC) change in each protocol.
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
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
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
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
Time frame: From date of enrolment until the date of recovery, last documented progression or date of death from any cause, whichever came first.
Number of RUTF delivered per child
Average number of RUTF delivered per child (SAM/MAM) in each protocol
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
Cost per child
Average number of dollars that cost to recovery a child in each cohort
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
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
Time frame: At the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Plan to share: No
Ran from Feb 2024 to primary completion in Aug 2024, 6 months.
Of 38 observational studies under Cachexia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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UNICEF - Venezuela